4-French-compatible endovascular material is safe and effective in the treatment of femoropopliteal occlusive disease: results of the 4-EVER trial

J Endovasc Ther. 2013 Dec;20(6):746-56. doi: 10.1583/13-4437MR.1.


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.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Alloys
  • Angioplasty, Balloon / adverse effects
  • Angioplasty, Balloon / instrumentation*
  • Belgium
  • Equipment Design
  • Female
  • Femoral Artery* / diagnostic imaging
  • Femoral Artery* / physiopathology
  • Germany
  • Humans
  • Male
  • Middle Aged
  • Peripheral Arterial Disease / diagnosis
  • Peripheral Arterial Disease / therapy*
  • Popliteal Artery* / diagnostic imaging
  • Popliteal Artery* / physiopathology
  • Prospective Studies
  • Radiography
  • Stents
  • Time Factors
  • Treatment Outcome
  • Ultrasonography, Doppler, Duplex
  • Vascular Access Devices*
  • Vascular Patency


  • Alloys
  • nitinol

Associated data

  • ClinicalTrials.gov/NCT01413139