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Results From the VISIBILITY Iliac Study: Primary and Cohort Outcomes at 9 Months.
- Source :
- Journal of Endovascular Therapy; Jun2017, Vol. 24 Issue 3, p342-348, 7p, 1 Diagram, 4 Charts, 1 Graph
- Publication Year :
- 2017
-
Abstract
- <bold>Purpose: </bold>To evaluate the safety and effectiveness of primary stenting of the common (CIA) or external iliac artery (EIA) using the Visi-Pro Balloon-Expandable Peripheral Stent System for treatment of stenotic, restenotic, or occluded lesions.<bold>Methods: </bold>Between 2011 and 2012, 75 patients (mean age 64.2±8.9 years; 46 men) with Rutherford category 2-4 ischemia and atherosclerotic lesions ≤10 cm in length underwent iliac artery stenting at 17 centers in the United States and Europe. The primary outcome of the study was the major adverse event (MAE) rate at 9 months postprocedure [composite of periprocedural death, in-hospital myocardial infarction, clinically driven target lesion revascularization (CD-TLR), and amputation of the treated limb]. Secondary outcomes included 30-day MAE rate, 9-month primary patency, changes in ankle-brachial index (ABI) and the Walking Impairment Questionnaire at 30 days and 9 months postprocedure, device success, and clinically driven target vessel revascularization (CD-TVR) at 30 days and 9 months. Outcomes in specific patient cohorts (ie, gender, stent location, calcification severity, and lesion grade) were analyzed.<bold>Results: </bold>Eighty-one stents were implanted in 61 CIA and 15 EIA lesions (41 with moderate/severe calcification). The mean lesion treated length was 29.3±13.9 mm. All devices were successfully deployed. MAE occurred in 3 (4.0%) of 75 subjects at 9 months. Primary patency and freedom from CD-TVR at 9 months were both 95.8%. ABI improved from 0.67±0.14 at baseline to 0.94±0.14 and 0.96±0.16 at 30 days and 9-month follow-up, respectively (p<0.001 for both). There were no differences with respect to any of the analyzed patient characteristics, including gender.<bold>Conclusion: </bold>Nine-month results of the VISIBILITY Iliac stent study ( ClinicalTrials.gov identifier NCT01402700) demonstrated safety and effectiveness for the treatment of atherosclerotic CIA and EIA lesions with the Visi-Pro stent across all treated cohorts. [ABSTRACT FROM AUTHOR]
- Subjects :
- PERIPHERAL vascular disease treatment
AMPUTATION
COMPARATIVE studies
ILIAC artery
LIMB salvage
LONGITUDINAL method
VASCULAR resistance
RESEARCH methodology
MEDICAL cooperation
PERIPHERAL vascular diseases
PROGNOSIS
RESEARCH
SURGICAL stents
TIME
TRANSLUMINAL angioplasty
EVALUATION research
STENOSIS
TREATMENT effectiveness
SEVERITY of illness index
ANKLE brachial index
KAPLAN-Meier estimator
EQUIPMENT & supplies
Subjects
Details
- Language :
- English
- ISSN :
- 15266028
- Volume :
- 24
- Issue :
- 3
- Database :
- Complementary Index
- Journal :
- Journal of Endovascular Therapy
- Publication Type :
- Academic Journal
- Accession number :
- 123120647
- Full Text :
- https://doi.org/10.1177/1526602817692960