Status:
COMPLETED
Remedy, Biodegradable Peripheral Stent Registry
Lead Sponsor:
be Medical
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
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. Pati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01420120
Start Date
January 1 2011
End Date
September 1 2014
Last Update
July 16 2015
Active Locations (1)
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1
University Hospital Ghent
Ghent, Belgium