Remedy, Biodegradable Peripheral Stent Registry

Completed

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT01420120
• Lead Sponsor: be Medical

Brief Summary

This is a prospective multicenter registry to evaluate safety and performance of the REMEDY, biodegradable peripheral stent for the treatment of occluded or stenotic superficial femoral arteries. Patients will be followed for a period of 1 year.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-08-16
• Study First Submitted QC: 2011-08-18
• Study First Posted: 2011-08-19
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-15
• Last Update Posted: 2015-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with symptomatic leg ischemia requiring treatment of SFA artery or proximal popliteal artery located within the following parameters:

  • 1 cm from the femoral bifurcation in the SFA
  • 3 cm from the proximal margin of the intercondylar fossa

• Rutherford-Becker Category 2-5. In patients with bilateral lesions, the highest Rutherford Category limb should be treated. Only 1 leg can be included.

• Single lesion which can be covered by one stent.

• Target vessel reference diameter ≥ 4 mm and ≤ 6 mm (by visual estimate)

• A patent popliteal artery free from significant stenosis (>50%) with at least one patent vessel runoff as confirmed by baseline angiography

• Signed informed consent.

Exclusion Criteria

• Pregnancy
• Previous stenting of target lesion
• Acute ischemia
• Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion). Inclusion of a patient is allowed in case inflow lesions are successfully treated during the index-procedure yielding less than 30% diameter stenosis.
• Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
• Known intolerance to study medications or contrast agents.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absence of clinically driven target lesion revascularization at 12 months.	12 months

Secondary Outcome Measures

Name	Time	Method
Primary and secondary patency rate	12 months	defined as \< 50% diameter reduction and peak systolic velocity \< 2.4 at 12 months.
Ankle-Brachial Index improvement of ≥ 0.1	1, 6 and 12 months
Clinically driven target vessel revascularization	6 and 12 months
Technical success	During procedure	Defined as a successful access and deployment of the device and determined by less than 30% residual stenosis by angiography at the baseline procedure.
Clinical success	During procedure	Defined as technical success without the occurrence of serious adverse events during procedure
Major complications at 6 and 12 months, including amputation of a part of the foot, the leg below and above the knee.	6 and 12 months
Rutherford-Becker classification of chronic limb ischemia	1, 6 and 12 months

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium