Remedy, Biodegradable Peripheral Stent Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No