Standard Balloon Angioplasty Versus Angioplasty With a Paclitaxel-eluting Balloon for Femoral Artery In-stent Restenosis

Study Overview
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Brief Summary
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Comparison of recurrent-restenosis rates 6 months after angioplasty of in-stent restenoses or in-stent reocclusions in the superficial femoral artery (SFA) using either a standard balloon (Admiral Xtreme, Invatec) or a paclitaxel-eluting balloon (In.Pact™ Admiral, Invatec).

Official Title
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Femoral Artery In-Stent Restenosis (FAIR) Trial

Conditions
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Peripheral Vascular Disease

Intervention / Treatment
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* Device: Admiral Xtreme
* Device: In.Pact Admiral


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 21 years old. Patient must sign informed consent form. Patient must agree to participate in the study and comply with follow-up requirements. Clinically, all patients must be in Rutherford category 2 to 4. Angiographic Inclusion Criteria: Planned angioplasty of in-stent restenoses (degree of stenosis 70-100%) within the SFA. The target lesion must not extend beyond the stent margins. In cases of two or more stenotic regions within the stented segment, these are considered separate lesions if there is a nonstenotic or only mildly stenotic (< 30%) segment of at least 2 cm in length between them. Otherwise, they are considered a single lesion. In case of separate lesions, only the proximal lesion will be taken as the target lesion! The length of the in-stent lesion should be at least 1 cm and maximally 20 cm (measurement by radiopaque ruler). The degree of target lesion stenosis must be determined by pre-interventional duplex ultrasound. The target lesion region starts at the origin of the SFA and ends distally at the femoropopliteal crossover (crossing by SFA of medial rim of femur in the PA projection). Patency (< 50% stenosis) of popliteal artery and at least 1 infragenicular artery. Exclusion Criteria: General: Patient is currently participating in another clinical trial. Pregnancy or pregnancy planned during study duration. Life expectancy less than 1 year. Co-morbidities preventing study participation. Severe coagulation disorders. Current treatment with anticoagulants other than aspirin, ticlopidine, clopidogrel or prasugrel. Active gastric ulcer or gastrointestinal bleeding. Thrombotic occlusion of the target vessel within previous 4 weeks. Treatment of target lesion with laser or atherectomy devices. Dialysis dependency. Manifest hyperthyreosis. Known allergy against contrast agent that cannot be adequately controlled by usual premedication. Known heparin intolerance. Known paclitaxel intolerance. Angiographic: Target lesion extends into the popliteal artery. Symptomatic untreated inflow lesion > 50% in ipsilateral iliac arteries. Pretreatment of iliac stenoses is possible. SFA lesions > 50% stenosis proximal and/or distal to the target lesion that require treatment. Target lesion extends beyond the stent margins.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standart balloon angioplasty<br>Admiral Xtreme, Invatec | Device: Admiral Xtreme<br>* For balloon angioplasty of in-stent restenosis in the superficial femoral artery<br>* Other names: Admiral Xtreme, Invatec;|
| Active Comparator: Paclitaxel-eluting balloon arm<br>In.Pact Admiral, Invatec | Device: In.Pact Admiral<br>* For balloon angioplasty of in-stent restenosis in the superficial femoral artery<br>* Other names: In.Pact Admiral, Invatec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duplex-ultrasound determined recurrent restenosis in the superficial femoral artery (SFA) | Binary restenosis rate by Duplex-ultrasound >= 50% measured as proximal peak velocity ratio PVR[prox] >= 2.4 | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent restenosis within the stent at 12 month | Recurrent restenosis >= 50% measured as proximal peak velocity ratio PVR[prox] >= 2.4 | 12 month | 
| Clinically driven target lesion revascularization (TLR) at 6 and 12 month |  | 6 and 12 month | 
| Recurrent stenosis >= 70% within the stent at 6 and 12 month | Recurrent restenosis >= 70% measured as proximal peak velocity ratio PVR[prox] >= 3.4 | 6 and 12 month | 
| Clinical and hemodynamic parameters | Walking distance, ABI, Rutherford category | at 1, 6 and 12 month | 
| Primary angiographic success rate | Angiographic sucess: <50% residual stenosis | 12 month | 
| Major adverse vascular events (MAVE) |  | 12 month | 
| Death |  | 12 month | 
| Impact of bail-out stent-in-stent placement on 6-and 12-month end points |  | 6 and 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Standard balloon angioplasty, POBA, Angioplasty with paclitaxel-eluting balloon, Superficial femoral artery