Paclitaxel Eluting Balloon and Conventional Balloon for In-Stent Restenosis of the Superficial Femoral Artery

Study Overview
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Brief Summary
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The aim of this study is to perform a randomized, controlled trial to compare percutaneous transluminal angioplasty using paclitaxel eluting balloon (PEB) or using a conventional balloon for treatment of superficial femoral artery in-stent restenosis.

Detailed Description
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The superficial femoral artery is a common place for arteriosclerosis in patients symptomatic for lower extremity vascular disease. Advances in percutaneous transluminal angioplasty (PTA) and stenting have provided new options for the treatment of the disease in this arterial segment. Restenosis after PTA occurs in 40-60% within one year. A novel attempt to reduce restenosis is the use of paclitaxel eluting balloons (PEB). First clinical studies suggest that the use of PEBs during percutaneous treatment of femoropopliteal disease is associated with significant reductions in late lumen loss and target-lesion revascularization. There is no randomized comparison of these treatments in patients with in stent restenosis of the superficial femoral artery. Thus, the aim of this study was to compare the efficacy of PTA with conventional balloon or PEB for in stent restenosis in the SFA in terms of reduction of diameter stenosis at follow-up angiogram.

Official Title
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Randomized Trial of Paclitaxel Eluting Balloon or Conventional Balloon for Treatment of In-Stent Restenosis of the Superficial Femoral Artery in Patients With Symptomatic Peripheral Artery Disease (ISAR-PEBIS)

Conditions
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Peripheral Vascular Disease

Intervention / Treatment
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* Device: PTA
* Device: PTA with PEB
* Procedure: Percutaneous Transluminal Angioplasty (PTA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic ≥ 70% in-stent restenosis of the AFS, (Rutherford stage 2-6) Written, informed consent by the patient or her/his legally-authorized representative for participation in the study Exclusion Criteria: Acute ischemia and/or acute thrombosis of the SFA Untreated ipsilateral iliac artery stenosis >70% Not at least one vessel run-off Popliteal involvement with stenosis >70% Severe renal insufficiency (GFR <30 ml/min/m2) Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance. Pregnancy (present, suspected or planned) or positive pregnancy test. Previous enrollment in this trial. Patient's inability to fully cooperate with the study protocol.

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional PTA<br>In stent restenosis is treated with PTA using a conventional balloon. | Device: PTA<br>* PTA using a conventional balloon<br>* Other names: PACIFIC XTREME, Invatec;Procedure: Percutaneous Transluminal Angioplasty (PTA)<br>* Percutaneous transluminal angioplasty with conventional balloon or paclitaxel-eluting balloon<br>* Other names: PACIFIC XTREME or IN.PACT PACIFIC balloons;|
| Experimental: PTA with PEB<br>In stent restenosis is treated with PTA using a paclitaxel eluting balloon. | Device: PTA with PEB<br>* PTA using a paclitaxel eluting balloon<br>* Other names: IN.PACT PACIFIC, Invatec;Procedure: Percutaneous Transluminal Angioplasty (PTA)<br>* Percutaneous transluminal angioplasty with conventional balloon or paclitaxel-eluting balloon<br>* Other names: PACIFIC XTREME or IN.PACT PACIFIC balloons;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage diameter stenosis |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 6 and 24 months | 
| Major adverse peripheral events (MAPE) defined as acute thrombosis of SFA or ipsilateral amputation or revascularization (PTA or bypass surgery) |  | 6 Months | 
| Time to onset of any of MAPE |  | 3-24 months | 
| Binary restenosis rate |  | 6 months | 
| Percentage diameter stenosis in duplex ultrasound |  | 6 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTA, paclitaxel, restenosis