Search

Abstract Background Calcified lesions are one of the most challenging cases for PCI, where optimal angiographic results and satisfying outcomes are hard to achieve. Methods We evaluated the baseline clinical, procedures characteristics and outcomes of patients with severe coronary artery calcification (CAC) who underwent coronary intravascular lithotripsy (IVL) and rotational atherectomy (RA). Results Respectively 152 and 238 patients who underwent IVL and RA are enrolled from January 2023 to November 2023. Regarding demographic characteristics, the gender proportion, medical history of PCI and smoke history among groups reach statistical significance. Left anterior descending and right coronary artery were the main vessels treated in both groups. The 2.5 and 3.0 mm IVL balloons and 1.5 mm burr were the most commonly used. 99.3% cases were successfully implanted drug-eluting stents after IVL balloon pre-treatment, which was higher than in the group treated with RA. During hospitalization, there were no serious adverse events in the IVL group, but there were two adverse events in the RA group. Procedural complications were higher in the RA group than the IVL group (5.5% vs. 0.7%, P = 0.027). Conclusions IVL appears to be safe and effective for the treatment of severe CAC lesions compared to RA.

Background: Calcified lesions are one of the most challenging cases for PCI, where optimal angiographic results and satisfying outcomes are hard to achieve. Methods: We evaluated the baseline clinical, procedures characteristics and outcomes of patients with severe coronary artery calcification (CAC) who underwent coronary intravascular lithotripsy (IVL) and rotational atherectomy (RA). Results: Respectively 152 and 238 patients who underwent IVL and RA are enrolled from January 2023 to November 2023. Regarding demographic characteristics, the gender proportion, medical history of PCI and smoke history among groups reach statistical significance. Left anterior descending and right coronary artery were the main vessels treated in both groups. The 2.5 and 3.0 mm IVL balloons and 1.5 mm burr were the most commonly used. 99.3% cases were successfully implanted drug-eluting stents after IVL balloon pre-treatment, which was higher than in the group treated with RA. During hospitalization, there were no serious adverse events in the IVL group, but there were two adverse events in the RA group. Procedural complications were higher in the RA group than the IVL group (5.5% vs. 0.7%, P = 0.027). Conclusions: IVL appears to be safe and effective for the treatment of severe CAC lesions compared to RA. [ABSTRACT FROM AUTHOR]

Abstract Background Current research results show that drug-coated balloons (DCB) have unique advantages in the treatment of in-stent restenosis, small vessel disease, bifurcation lesions, and de novo lesions, but the data regarding rotational atherectomy (RA) followed by DCB treatment in calcified lesions, especially severe coronary artery calcification (CAC), are limited. Methods A retrospective study was conducted on 318 individuals with severe CAC who underwent RA-assisted PCI at the First Affiliated Hospital of Zhengzhou University from May 2018 to July 2021. Among them, 57 patients (RA/DCB group) were treated with DCB, and 261 patients (RA/DES group) were treated with drug-eluting stents (DES). The two groups' clinical baseline data, lesion characteristics, intraoperative complications, in-hospital adverse events, and major adverse cardiovascular and cerebrovascular events (MACCE) were compared throughout the follow-up period. Results The baseline clinical data, intraoperative complications, and in-hospital adverse events were not significantly different between the two groups. The anatomical categories in the RA/DES group were more complex and included left main coronary disease, bifurcation disease, and multivessel disease. Although target lesion revascularization (13.79% vs. 7.02%) and MACCE (18.77% vs. 12.28%) occurred more frequently in the RA/DES group than in the RA/DCB group, there was no statistically significant difference (p > 0.05). Multivariate Cox regression analysis showed that bifurcation lesions (HR 2.284, 95% CI 1.063–4.908, p = 0.034), total length of DCB/DES (HR 1.023, 95% CI 1.005–1.047, p = 0.014) and SYNTAX score (HR 1.047, 95% CI 1.013–1.082, p = 0.006) were independent risk factors for MACCE during the follow-up period. Conclusion Drug-coated balloon treatment after rotational atherectomy appears safe and effective in selected severe coronary artery calcification.

Background: Current research results show that drug-coated balloons (DCB) have unique advantages in the treatment of in-stent restenosis, small vessel disease, bifurcation lesions, and de novo lesions, but the data regarding rotational atherectomy (RA) followed by DCB treatment in calcified lesions, especially severe coronary artery calcification (CAC), are limited. Methods: A retrospective study was conducted on 318 individuals with severe CAC who underwent RA-assisted PCI at the First Affiliated Hospital of Zhengzhou University from May 2018 to July 2021. Among them, 57 patients (RA/DCB group) were treated with DCB, and 261 patients (RA/DES group) were treated with drug-eluting stents (DES). The two groups' clinical baseline data, lesion characteristics, intraoperative complications, in-hospital adverse events, and major adverse cardiovascular and cerebrovascular events (MACCE) were compared throughout the follow-up period. Results: The baseline clinical data, intraoperative complications, and in-hospital adverse events were not significantly different between the two groups. The anatomical categories in the RA/DES group were more complex and included left main coronary disease, bifurcation disease, and multivessel disease. Although target lesion revascularization (13.79% vs. 7.02%) and MACCE (18.77% vs. 12.28%) occurred more frequently in the RA/DES group than in the RA/DCB group, there was no statistically significant difference (p > 0.05). Multivariate Cox regression analysis showed that bifurcation lesions (HR 2.284, 95% CI 1.063–4.908, p = 0.034), total length of DCB/DES (HR 1.023, 95% CI 1.005–1.047, p = 0.014) and SYNTAX score (HR 1.047, 95% CI 1.013–1.082, p = 0.006) were independent risk factors for MACCE during the follow-up period. Conclusion: Drug-coated balloon treatment after rotational atherectomy appears safe and effective in selected severe coronary artery calcification. [ABSTRACT FROM AUTHOR]

Abstract Background The interventional treatment of calcified lesions with severe tortuosity in the left anterior descending artery (LAD) was challenging and the report of rotational atherectomy with mother-and-child technique has been scarce. Case presentation An 84-year-old woman was hospitalized for non-ST-segment acute coronary syndrome. Coronary angiography revealed a calcified nodule in the LAD. During rotational atherectomy of the calcified and tortuous lesion in the proximal LAD, eccentric cutting due to wire bias nearly caused perforation. The burr seemed to protrude from the contrast media during angiography. Intravascular ultrasound imaging revealed that extremely eccentric ablation almost reached the adventitia. We successfully ablated the distal calcified nodule by preventing proximal overcutting of the tortuous lesion with support from a guide extension catheter, i.e., the mother-and-child technique, followed by the deployment of the drug-eluting stent. The patient was discharged without chest symptoms and no symptom recurred during 12-month follow-up. Conclusion This case demonstrated that safe ablation of a calcified nodule located distal to a tortuous and calcified lesion in the proximal LAD with the mother-and-child technique.

Abstract Background To compare the effect and outcomes of optical coherence tomography (OCT)-guided rotational atherectomy (RA) with intravascular ultrasound (IVUS)-guided RA in the treatment of calcified coronary lesions. Methods Data of calcified coronary lesions treated with RA that underwent OCT-guided or IVUS-guided from January 2016 to December 2019 at a single-center registry were retrospectively analyzed. The effect and outcomes between underwent OCT-guided RA and IVUS-guided RA were compared. Results A total of 33 lesions in 32 patients received OCT-guided RA and 51 lesions in 47 patients received IVUS-guided RA. There was no significant difference between OCT-guided RA group and IVUS-guided RA group in clinical baselines characteristics. Comparing the procedural and lesions characteristics of the two groups, the contrast volume was larger [(348.8 ± 110.6) ml vs. (275.2 ± 76.8) ml, P = 0.002] and the scoring balloon was more frequently performed (33.3% vs. 3.9%, P = 0.001) after RA and before stenting in the OCT-guided RA group. Comparing the intravascular imaging findings of the two groups, stent expansion was significantly larger in the OCT-guided RA group ([82 ± 8]% vs. [75 ± 9]%, P = 0.001). Both groups achieved procedural success immediately. There were no significantly differences in the incidence of complications. Although there was no statistical difference in the occurrence of MACE at 1 year between OCT-guided RA group and IVUS-guided RA group (3.1% vs. 6.4%, P = 0.517), no cardiovascular death, TVR and stent thrombosis occurred in OCT-guided RA group. Conclusions OCT-guided RA compared to IVUS-guided RA for treating calcified coronary lesions resulted in better stent expansion and may have improved prognosis.

Abstract Background Stent ablation with rotational atherectomy has been considered a bail-out strategy for the treatment of severe stent underexpansion. Only a few reports have yet shown rotational ablation for double-layer metal struts. Case presentation We present a case of 80-year-old female patient presented to our hospital because of worsening effort angina. Coronary angiography revealed severe in-stent restenosis in the proximal left anterior descending artery. Optical coherence tomography (OCT) examinations found that severe stenosis occurred at the overlap region with 2-layer underexpanded stents and circumferential calcification beneath them. Under the guidance of 2-dimensional (2D) and 3-dimensional (3D) OCT, we successfully performed percutaneous coronary intervention (PCI) of this lesion after adequate stent ablation, high-pressure balloon dilatation, and subsequent everolimus-eluting stent implantation. The patient recovered well uneventfully and discharged from hospital 7 days later. No restenosis occurred after 12 months. Conclusions We report a very rare case of in-stent restenosis due to double-layer underexpanded stents. The entire percutaneous coronary intervention procedure was performed step by step under the guidance of high-resolution OCT. Our findings highlight the specific value of 2D and 3D OCT guidance in double-layer stents rotational ablation.

Background: The interventional treatment of calcified lesions with severe tortuosity in the left anterior descending artery (LAD) was challenging and the report of rotational atherectomy with mother-and-child technique has been scarce.Case Presentation: An 84-year-old woman was hospitalized for non-ST-segment acute coronary syndrome. Coronary angiography revealed a calcified nodule in the LAD. During rotational atherectomy of the calcified and tortuous lesion in the proximal LAD, eccentric cutting due to wire bias nearly caused perforation. The burr seemed to protrude from the contrast media during angiography. Intravascular ultrasound imaging revealed that extremely eccentric ablation almost reached the adventitia. We successfully ablated the distal calcified nodule by preventing proximal overcutting of the tortuous lesion with support from a guide extension catheter, i.e., the mother-and-child technique, followed by the deployment of the drug-eluting stent. The patient was discharged without chest symptoms and no symptom recurred during 12-month follow-up.Conclusion: This case demonstrated that safe ablation of a calcified nodule located distal to a tortuous and calcified lesion in the proximal LAD with the mother-and-child technique. [ABSTRACT FROM AUTHOR]

Abstract Background The interventional treatment of chronic total occlusion (CTO) with stent fracture as well as severe calcification was extremely difficult and no effective technique has been reported. Case presentation A 50-year-old woman was hospitalized for angina, angiography revealed triple vessel disease, CTO accompanied with stent fracture in right coronary artery (RCA). Treatment using conventional coronary intervention was expected to be difficult. Therefore, we performed RASER technique, which was a combination of excimer laser coronary atherectomy (ELCA) with rotational atherectomy (RA), followed by the deployment of drug-eluting stents. Intravascular ultrasound (IVUS) revealed well attachment of the stents, the patient was discharged 3 days after the procedure and no recurrent chest discomfort was reported in a follow-up time of 10 months. Conclusion This case report provided a first report of RASER technique in the treatment of CTO with stent fracture and severe calcification.

Background: To compare the effect and outcomes of optical coherence tomography (OCT)-guided rotational atherectomy (RA) with intravascular ultrasound (IVUS)-guided RA in the treatment of calcified coronary lesions.Methods: Data of calcified coronary lesions treated with RA that underwent OCT-guided or IVUS-guided from January 2016 to December 2019 at a single-center registry were retrospectively analyzed. The effect and outcomes between underwent OCT-guided RA and IVUS-guided RA were compared.Results: A total of 33 lesions in 32 patients received OCT-guided RA and 51 lesions in 47 patients received IVUS-guided RA. There was no significant difference between OCT-guided RA group and IVUS-guided RA group in clinical baselines characteristics. Comparing the procedural and lesions characteristics of the two groups, the contrast volume was larger [(348.8 ± 110.6) ml vs. (275.2 ± 76.8) ml, P = 0.002] and the scoring balloon was more frequently performed (33.3% vs. 3.9%, P = 0.001) after RA and before stenting in the OCT-guided RA group. Comparing the intravascular imaging findings of the two groups, stent expansion was significantly larger in the OCT-guided RA group ([82 ± 8]% vs. [75 ± 9]%, P = 0.001). Both groups achieved procedural success immediately. There were no significantly differences in the incidence of complications. Although there was no statistical difference in the occurrence of MACE at 1 year between OCT-guided RA group and IVUS-guided RA group (3.1% vs. 6.4%, P = 0.517), no cardiovascular death, TVR and stent thrombosis occurred in OCT-guided RA group.Conclusions: OCT-guided RA compared to IVUS-guided RA for treating calcified coronary lesions resulted in better stent expansion and may have improved prognosis. [ABSTRACT FROM AUTHOR]

Background: Stent ablation with rotational atherectomy has been considered a bail-out strategy for the treatment of severe stent underexpansion. Only a few reports have yet shown rotational ablation for double-layer metal struts.Case Presentation: We present a case of 80-year-old female patient presented to our hospital because of worsening effort angina. Coronary angiography revealed severe in-stent restenosis in the proximal left anterior descending artery. Optical coherence tomography (OCT) examinations found that severe stenosis occurred at the overlap region with 2-layer underexpanded stents and circumferential calcification beneath them. Under the guidance of 2-dimensional (2D) and 3-dimensional (3D) OCT, we successfully performed percutaneous coronary intervention (PCI) of this lesion after adequate stent ablation, high-pressure balloon dilatation, and subsequent everolimus-eluting stent implantation. The patient recovered well uneventfully and discharged from hospital 7 days later. No restenosis occurred after 12 months.Conclusions: We report a very rare case of in-stent restenosis due to double-layer underexpanded stents. The entire percutaneous coronary intervention procedure was performed step by step under the guidance of high-resolution OCT. Our findings highlight the specific value of 2D and 3D OCT guidance in double-layer stents rotational ablation. [ABSTRACT FROM AUTHOR]

Abstract Background Percutaneous coronary interventions (PCI) of old calcified saphenous vein grafts (SVGs) is challenging and is associated with a considerably high risk of adverse ischemic events in the short- and long-term as compared to native coronary arteries. We report a case in which a non-dilatable, calcified SVG lesion is successfully treated with rotational atherectomy followed by PCI and stenting with local stent delivery (LSD) technique using the Guidezilla™ guide extension catheter (5-in-6 Fr) in the “child-in-mother” fashion. Case presentation A 70 years-old man with a dilated ischemic cardiomyopathy, triple coronary artery bypass grafting (CABG) in 1990 and chronic renal failure (baseline GFR: 45 ml/min/1.73 m2) underwent a coronary angiography for a Non-ST segment elevation myocardial infarction (NSTEMI). Native coronary circulation was completely occluded at the proximal segments. Grafts angiography showed a tandem calcified lesions of SVG on distal right coronary artery (RCA) and an ostial stenosis of the SVG on first obtuse marginal branch (OM1). Left internal mammary artery on the mid left anterior descending artery was patent. Ad Hoc PCI of SVG on RCA was attempted. The proximal calcified stenosis has been crossed with a 1.5 x 12 mm balloon only with the support of Guidezilla™, however the non-compliant (NC) balloon 2.5 x 15 mm was unable to break the hard and calcified plaque. After several attempts, the procedure was interrupted with a suboptimal result. An elective transradial PCI of SVG on RCA with rotational atherectomy was performed. Two runs with 1.25 mm burr and 2 runs with 1.5 mm burr were carried out. Then, the use of distal anchoring balloon warranted support and tracking, made as centring rail for the advance of the tip of the “mother-and-child” catheter into the SVG. During slow deflation of the balloon, the Guidezilla™ was advanced distal to the stenoses to be stented, thus allowing the placement of two long drug eluting stents according to a LSD technique. Conclusions Rotational atherectomy is a feasible option for non-dilatable stenoses in old SVGs when there is no evidence of thrombus or vessel dissection and the subsequent use of “mother-and-child” catheter has a key role, especially in case of radial approach, for long stents delivery.

Background: The interventional treatment of chronic total occlusion (CTO) with stent fracture as well as severe calcification was extremely difficult and no effective technique has been reported.Case Presentation: A 50-year-old woman was hospitalized for angina, angiography revealed triple vessel disease, CTO accompanied with stent fracture in right coronary artery (RCA). Treatment using conventional coronary intervention was expected to be difficult. Therefore, we performed RASER technique, which was a combination of excimer laser coronary atherectomy (ELCA) with rotational atherectomy (RA), followed by the deployment of drug-eluting stents. Intravascular ultrasound (IVUS) revealed well attachment of the stents, the patient was discharged 3 days after the procedure and no recurrent chest discomfort was reported in a follow-up time of 10 months.Conclusion: This case report provided a first report of RASER technique in the treatment of CTO with stent fracture and severe calcification. [ABSTRACT FROM AUTHOR]

Background: Percutaneous coronary interventions (PCI) of old calcified saphenous vein grafts (SVGs) is challenging and is associated with a considerably high risk of adverse ischemic events in the short- and long-term as compared to native coronary arteries. We report a case in which a non-dilatable, calcified SVG lesion is successfully treated with rotational atherectomy followed by PCI and stenting with local stent delivery (LSD) technique using the Guidezilla™ guide extension catheter (5-in-6 Fr) in the "child-in-mother" fashion.Case Presentation: A 70 years-old man with a dilated ischemic cardiomyopathy, triple coronary artery bypass grafting (CABG) in 1990 and chronic renal failure (baseline GFR: 45 ml/min/1.73 m2) underwent a coronary angiography for a Non-ST segment elevation myocardial infarction (NSTEMI). Native coronary circulation was completely occluded at the proximal segments. Grafts angiography showed a tandem calcified lesions of SVG on distal right coronary artery (RCA) and an ostial stenosis of the SVG on first obtuse marginal branch (OM1). Left internal mammary artery on the mid left anterior descending artery was patent. Ad Hoc PCI of SVG on RCA was attempted. The proximal calcified stenosis has been crossed with a 1.5 x 12 mm balloon only with the support of Guidezilla™, however the non-compliant (NC) balloon 2.5 x 15 mm was unable to break the hard and calcified plaque. After several attempts, the procedure was interrupted with a suboptimal result. An elective transradial PCI of SVG on RCA with rotational atherectomy was performed. Two runs with 1.25 mm burr and 2 runs with 1.5 mm burr were carried out. Then, the use of distal anchoring balloon warranted support and tracking, made as centring rail for the advance of the tip of the "mother-and-child" catheter into the SVG. During slow deflation of the balloon, the Guidezilla™ was advanced distal to the stenoses to be stented, thus allowing the placement of two long drug eluting stents according to a LSD technique.Conclusions: Rotational atherectomy is a feasible option for non-dilatable stenoses in old SVGs when there is no evidence of thrombus or vessel dissection and the subsequent use of "mother-and-child" catheter has a key role, especially in case of radial approach, for long stents delivery. [ABSTRACT FROM AUTHOR]

Background: Heavy coronary artery calcification is responsible for stent underexpansion, which is associated with increased in-stent restenosis. Here we report a case in which optical coherence tomography (OCT) demonstrated that the metal component of an underexpanded stent previously implanted in a heavy calcified lesion had been completely removed after ablation with rotational atherectomy. Case presentation: An 83-year-old man with exertional angina was referred to our hospital. Coronary angiography revealed severe stenosis in the proximal portion of the right coronary artery and left circumflex artery and chronic total occlusion (CTO) in the mid portion of the left anterior descending artery (LAD). We performed complete revascularization with percutaneous coronary intervention. Because the CTO lesion in LAD contained napkin-ring heavy calcifications, rotational atherectomy with a 1.75-mm burr was undergone, followed by the deployment of drug-eluting stents and postdilation with a high-pressure balloon. However, expansion of the stent was incomplete. To address the recurrence of in-stent restenosis and resistance to the dilation with the high-pressure balloon, we decided to simultaneously ablate both the heavy calcification and underexpanded stent. Longitudinal stent ablation with 1.75- and 2.0-mm burrs was successful, and OCT demonstrated that the metallic component of the underexpanded stent had been completely removed. Conclusion: If a stent fails to completely extend in heavy calcification, longitudinal stent ablation by rotational atherectomy could be an effective remedy. [ABSTRACT FROM AUTHOR]

Background: This study investigated whether, for patients with severely calcified coronary lesions, use of a cutting balloon (CB) during rotational atherectomy (RA) before placing a drug-eluting stent will improve periprocedural outcomes, compared to RA with a conventional plain balloon.Methods: In a randomized controlled trial, patients with severely calcified lesions of calcium arc ≥180° were apportioned to receive intensive plaque modification with RA and CB (RA + CB; n = 35) or RA with conventional plain balloon (RA; n = 36). Intravascular ultrasound was applied for quantitative or qualitative analyses of percutaneous coronary intervention outcomes. The primary outcome was acute lumen gain after drug-eluting stent.Results: The RA + CB and RA groups were similar in baseline mean arcs of superficial calcium, and minimum lumen cross-sectional areas (CSAs). The mean minimum stent CSA after percutaneous coronary intervention (PCI) of the RA + CB group (5.9 ± 1.7 mm(2)) was significantly larger than that of the RA group (5.0 ± 1.4 mm(2); P = 0.021). Patients in the RA + CB group achieved significantly larger acute CSA gain after PCI (4.5 ± 1.5 mm(2)) relative to the RA group (3.8 ± 1.5 mm(2); P = 0.035). The groups were similar in rates of periprocedural complications, but at the 1-year follow-up the RA + CB had a lower rate of revascularization for restenosis of the target vessel and MACE (5.7 %) than did the RA group (22.2 %, P = 0.046).Conclusion: Aggressive plaque preparation with RA and CB seems to be safe and effective for patients with severely calcified coronary lesions.Trial Registration: Current Controlled Trials ChiCTR-INR-16008274 . Retrospectively registered 12 April 2016. [ABSTRACT FROM AUTHOR]

Background: Heavy coronary artery calcification is responsible for stent underexpansion, which is associated with increased in-stent restenosis. Here we report a case in which optical coherence tomography (OCT) demonstrated that the metal component of an underexpanded stent previously implanted in a heavy calcified lesion had been completely removed after ablation with rotational atherectomy., Case Presentation: An 83-year-old man with exertional angina was referred to our hospital. Coronary angiography revealed severe stenosis in the proximal portion of the right coronary artery and left circumflex artery and chronic total occlusion (CTO) in the mid portion of the left anterior descending artery (LAD). We performed complete revascularization with percutaneous coronary intervention. Because the CTO lesion in LAD contained napkin-ring heavy calcifications, rotational atherectomy with a 1.75-mm burr was undergone, followed by the deployment of drug-eluting stents and postdilation with a high-pressure balloon. However, expansion of the stent was incomplete. To address the recurrence of in-stent restenosis and resistance to the dilation with the high-pressure balloon, we decided to simultaneously ablate both the heavy calcification and underexpanded stent. Longitudinal stent ablation with 1.75- and 2.0-mm burrs was successful, and OCT demonstrated that the metallic component of the underexpanded stent had been completely removed., Conclusion: If a stent fails to completely extend in heavy calcification, longitudinal stent ablation by rotational atherectomy could be an effective remedy.

Background: This study investigated whether, for patients with severely calcified coronary lesions, use of a cutting balloon (CB) during rotational atherectomy (RA) before placing a drug-eluting stent will improve periprocedural outcomes, compared to RA with a conventional plain balloon., Methods: In a randomized controlled trial, patients with severely calcified lesions of calcium arc ≥180° were apportioned to receive intensive plaque modification with RA and CB (RA + CB; n = 35) or RA with conventional plain balloon (RA; n = 36). Intravascular ultrasound was applied for quantitative or qualitative analyses of percutaneous coronary intervention outcomes. The primary outcome was acute lumen gain after drug-eluting stent., Results: The RA + CB and RA groups were similar in baseline mean arcs of superficial calcium, and minimum lumen cross-sectional areas (CSAs). The mean minimum stent CSA after percutaneous coronary intervention (PCI) of the RA + CB group (5.9 ± 1.7 mm(2)) was significantly larger than that of the RA group (5.0 ± 1.4 mm(2); P = 0.021). Patients in the RA + CB group achieved significantly larger acute CSA gain after PCI (4.5 ± 1.5 mm(2)) relative to the RA group (3.8 ± 1.5 mm(2); P = 0.035). The groups were similar in rates of periprocedural complications, but at the 1-year follow-up the RA + CB had a lower rate of revascularization for restenosis of the target vessel and MACE (5.7 %) than did the RA group (22.2 %, P = 0.046)., Conclusion: Aggressive plaque preparation with RA and CB seems to be safe and effective for patients with severely calcified coronary lesions., Trial Registration: Current Controlled Trials ChiCTR-INR-16008274 . Retrospectively registered 12 April 2016.