Remedy, Biodegradable Peripheral Stent Registry

BE Medical

Status: Completed

Conditions: Peripheral Arterial Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT01420120

BM-REM-03-003

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.