Paclitaxel-coated Balloons in Femoral Indication to Defeat Restenosis

Study Overview
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Brief Summary
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The aim of the study is correlating efficacy of the treatment to the proportion of paclitaxel-dose supplied by the catheter. Forty-five patients each will be treated by paclitaxel-coated or uncoated conventional balloon catheters in randomized order in 3 study centers. Main inclusion criteria are Rutherford class 2 - 5, ≥70% stenosis or occlusion in the superficial femoral or popliteal artery, main exclusion criteria are related to the use of paclitaxel and the need for follow-up examinations. Either clinical or angiographic follow-up examinations are planned 6, 12 and 24 months following the intervention. Primary endpoint is 6-month angiographic late lumen loss. Secondary endpoints are further angiographic and clinical efficacy and various safety criteria.

Detailed Description
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Paclitaxel-coated balloons have been shown to reduce late lumen loss, restenosis rates and the need for repeat target lesion revascularization compared to conventional uncoated balloon catheters. The aim of the study is correlating efficacy of the treatment to the proportion of paclitaxel-dose supplied by the catheter. To this end paclitaxel loss of catheters in the introductory sheaths and residual paclitaxel on used balloons will be determined and correlated to individual data indicating inhibition of neointimal proliferation. According to the study protocol 45 patients each will be treated by paclitaxel-coated or uncoated conventional balloon catheters in randomized order in 3 study centers. Main inclusion criteria are Rutherford class 2 - 5, ≥70% stenosis or occlusion in the superficial femoral or popliteal artery, 3 to 30 cm of length; beyond common contraindications against PTA main exclusion criteria are related to the use of paclitaxel and the need for follow-up examinations. Patients will be blinded against treatment. Blinding of investigators after assignment of a patient to a treatment is not possible due to differences in the appearance of coated and uncoated catheters. Either clinical or angiographic follow-up examinations are planned 6, 12 and 24 months following the intervention. Primary endpoint is 6-month angiographic late lumen loss evaluated by a blinded independent core lab. Secondary endpoints are interventional success rate, restenosis rates, minimal lumen diameter, target lesion revascularization, change in Rutherford class, change in ankle-brachial-index, major amputations, a composite safety endpoint (defined as MAE =death of any cause, target limb amputation, clinically / DUS driven TLR) and all kinds of serious adverse events possibly related to the treatment.

Official Title
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Paclitaxel-coated Balloons in Femoral Indication to Defeat Restenosis

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Device: Percutaneous transluminal angioplasty (PTA)
* Combination Product: DCB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with PAOD, Rutherford stage 2-5, Occlusion or stenosis >70% in diameter of at least 3 cm length in the superficial femoral artery and/ or popliteal artery Exclusion Criteria: Acute thrombus or aneurysm in the index limb/ vessel Doubts in the willingness or capability of the patient to allow follow up examination
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>Angioplasty of SFA with uncoated balloon catheters | Device: Percutaneous transluminal angioplasty (PTA)<br>* Angioplasty of superficial femoral artery (SFA)<br>* Other names: uncoated PTA;|
| Experimental: Drug coated balloon<br>Angioplasty of SFA with paclitaxel-coated balloon catheters | Combination Product: DCB<br>* Drug Coated Balloon Angioplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late lumen loss | Efficacy of paclitaxel coated percutaneous transluminal angioplasty (PTA) balloons in inhibiting restenosis of femoropopliteal arteries (late lumen loss) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic and clinical efficacy measures | Various angiographic and clinical efficacy measures, safety and tolerance of paclitaxel coated PTA balloons in inhibiting restenosis of femoropopliteal arteries: Target lesion revascularization (Target lesion revascularization is defined as any reintervention or artery bypass graft surgery involving the target lesion.) Change in Rutherford stage compared to pretreatment Major amputations at the index limb Pre-defined event free survival | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pAVK, PTA, drug coated balloon