A Prospective Multicenter Registry to Evaluate Safety and Performance of REMEDY, Biodegradable Peripheral Stent for the Treatment of Occluded or Stenotic Superficial Femoral Arteries.

be Medical1 site in 1 country100 target enrollmentJanuary 2011

ConditionsPeripheral Arterial Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Peripheral Arterial Disease
Sponsor: be Medical
Enrollment: 100
Locations: 1
Primary Endpoint: Absence of clinically driven target lesion revascularization at 12 months.
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

September 2014

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

be Medical

Eligibility Criteria

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-
•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.

Outcomes

Primary Outcomes

Absence of clinically driven target lesion revascularization at 12 months.

Time Frame: 12 months

Secondary Outcomes

Primary and secondary patency rate(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)
Clinical success(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)