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Purpose: To report the 1-year results of a prospective multicenter trial to evaluate the safety and efficacy of treating symptomatic femoropopliteal occlusive disease using 4-F-compatible materials and no closure device., Methods: The non-randomized 4-EVER trial (4-F endovascular treatment approach to infrainguinal disease) was conducted at 5 European hospitals (ClinicalTrials.gov identifier NCT01413139). The protocol mandated the use of only 4-F sheaths, self-expanding nitinol stents (Astron Pulsar or Pulsar-18 stent), and balloons from a single manufacturer. Between June 2010 and June 2011, 120 symptomatic patients (82 men; mean age 71±9.7 years, range 47-90), primarily claudicants, treated for 120 femoropopliteal lesions (>90% TASC A/B) were enrolled. The mean lesion length was 71.0±45.9 mm. Follow-up evaluations were scheduled on day 1 and at 1, 6, 12, and 24 months. A duplex ultrasound was performed on all follow-up visits to determine vessel patency (primary outcome measure at 1 year), and biplanar radiography was performed at 12 and 24 months to assess stent fracture., Results: Stents were successfully implanted in all patients: an Astron Pulsar stent in 70 (58.3%) lesions and a Pulsar-18 stent in 46 (38.3%); 4 (3.3%) patients had both stents implanted for flow-limiting dissection after predilation. No closure devices were used; the mean manual compression time was 8.1 minutes (2-15). Four (3.3%) patients developed significant hematoma at the puncture site, but none required surgical repair. The overall 12-month primary patency rate was 81.4%: 85.2% for the Astron Pulsar and 73.4% for the Pulsar-18 (p=0.236). Freedom from target lesion revascularization at 12 months for the entire cohort was 89.3%., Conclusion: Compared to published historical data for superficial femoral artery type A/B lesion stenting using 6-F devices, the 4-F devices applied in this trial showed similar patency at 12 months, fewer access site complications, and shorter manual compression times, supporting the supposition that 4-F endovascular treatment is safe and effective.

The importance of angioplasty and stenting in the treatment of carotid artery disease cannot be underestimated. Successful carotid stenting does not only depend on the operator's skills and experience but also on an adequate selection of cerebral protection devices, and carotid stents can help avoid neurological complications. A broad spectrum of carotid devices is currently on the market, and because each of them has its own advantages and disadvantages, it is virtually impossible to claim that one specific device is the best. The individual characteristics of each specific protection system or stent may make it an attractive choice in one circumstance but render it a less desirable option in other situations. The applicability depends primarily on the arterial anatomy and the specific details of the lesion being treated. But certainly, personal preferences and familiarity with a specific device may legitimately influence the decision to choose one over another.

Purpose: To report the preliminary 3-month follow-up of a recently developed absorbable metal stent (AMS) for treatment of infrapopliteal lesions in patients with critical limb ischemia (CLI)., Methods: Between December 2003 and January 2004, 20 patients (10 men; mean age 76 years, range 59-96) with symptomatic critical limb ischemia (CLI) due to high-grade (80% to 100%) infrapopliteal stenoses received 1 or 2 AMS devices for suboptimal angioplasty. Clinical examination and color-flow duplex imaging were performed in all patients at discharge and at 1 and 3 months., Results: Angiographic procedural success was achieved in all 20 patients. One patient died (non-procedure-related) during the periprocedural period. Three months after the procedure, primary clinical patency was 89.5% (17/19). No major or minor amputation was necessary in any of the patients, yielding a limb salvage rate of 100%. The average improvement in Rutherford class was 2.3 at the 3-month assessment. A comparison of postprocedural and 1-month color-flow duplex ultrasound and magnetic resonance images clearly indicated the ongoing absorption process of the AMS., Conclusions: After 3 months, the primary clinical patency and limb salvage rates suggest a potentially promising performance of these AMS devices in the treatment of below-knee lesions in CLI patients.