A Prospective, Multi-center, Single Arm Study With a Nitinol Self-Expanding Paclitaxel-Eluting Stent in the Treatment of Atherosclerotic Tibial-peroneal Arteries

Flanders Medical Research Program5 sites in 1 country70 target enrollmentJanuary 2012

ConditionsPeripheral Arterial Disease

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Peripheral Arterial Disease
Sponsor: Flanders Medical Research Program
Enrollment: 70
Locations: 5
Primary Endpoint: Primary patency
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this clinical study is to evaluate the immediate and long-term (up to 12 month) safety and effectiveness of a Nitinol Self-Expanding Paclitaxel-Eluting stent for the treatment of patients with critical limb ischemia (i.e. rest pain or non-healing foot ulcers) due to the presence of arterial lesions in the below-the-knee arteries of maximally 50mm long.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

October 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Flanders Medical Research Program

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient presenting with rest pain or minor tissue loss (Rutherford Clinical Category 4 or 5)
•Patient is willing to comply with specified follow-up evaluations at the specified times
•Patient is \>18 years old
•Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
•Patient has a projected life-expectancy of at least 12 months
•Patient is eligible for treatment with a Self-Expanding Paclitaxel-Eluting stent
•Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure
•Evidence at screening of ≥50% de novo lesion (or restenosis after previous PTA) in the infrapopliteal arteries, confirmed by angiography
•Reference vessel diameter visually estimated to be ≥3.0mm and ≤4.5mm
•Identifiable distal target vessel which upon completion of the intervention, is anticipated to provide reconstitution of blood flow to the foot.

Exclusion Criteria

•Untreated flow-limiting inflow lesions
•Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
•Has had a previous peripheral bypass affecting the target limb
•Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
•Non-atherosclerothic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
•Patient has a contra-indication or known untreated allergy to anti-platelet therapy, anticoagulants, thrombolytic drugs or any other drug anticipated to be used
•Patient has hypersensitivity to contrast or device material that cannot be adequately pretreated
•Patient has known uncontrollable hypercoagulable condition, or refuses blood transfusion
•Life expectancy of less than 12 months
•Patient is currently participating in an investigational drug or another device study that may clinically interfere with the study endpoints

Outcomes

Primary Outcomes

Primary patency

Time Frame: 12 months

Primary patency at 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on angiography, verified by Core Lab