Peripheral Arterial Disease
Conditions
Keywords
Biodegradable stent, PAD
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.
Interventions
None listed
Sponsors
be Medical
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence of clinically driven target lesion revascularization at 12 months. | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Primary and secondary patency rate | 12 months | defined as \< 50% diameter reduction and peak systolic velocity \< 2.4 at 12 months. |
| Rutherford-Becker classification of chronic limb ischemia | 1, 6 and 12 months | — |
| Clinically driven target vessel revascularization | 6 and 12 months | — |
| 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 | — |
| Ankle-Brachial Index improvement of ≥ 0.1 | 1, 6 and 12 months | — |
Countries
Belgium
Outcome results
None listed