Drug Eluting Balloon Angioplasty Versus Nitinol Stent Implantation in the Superficial Femoral Artery

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether the results of drug eluting balloon are non-inferior to the Nitinol stent implantation in the femoropopliteal segment.

Official Title
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Randomized Controlled Trial of Paclitaxel Drug-coated Balloons vs. Nitinol Stent for Femoropopliteal Obstructions - The PAVENST Trial

Conditions
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Peripheral Arterial Disease, Arterial Occlusive Diseases, Atherosclerosis, Arteriosclerosis, Cardiovascular Diseases, Peripheral Vascular Diseases, Paclitaxel, Plaque, Atherosclerotic, Critical Limb Ischemia

Intervention / Treatment
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* Device: Drug Eluting Balloon Angioplasty
* Device: Nitinol stenting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years with critical lower limb ischemia, Ruhtherford 3 or higher, with angiographic documentation of greater than 70% or occlusion in the superficial femoral artery, with a maximum extension of 10 cm stenosis. The popliteal artery and at least one leg artery must be patent. Exclusion Criteria: Pregnancy, thrombophilia, coagulation disorders, presence of active or recent bleeding, severe allergy to iodinated contrast, renal or hepatic disease, acute limb ischemia, prior surgical bypass or angioplasty (with or without stent) on the target artery, obstructive disease (stenosis> 50%) of the aortoiliac segment ipsilateral to the target (if the aortoiliac is pre-treated, the patient may be included)

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
Interventional Model Description: Prospective, randomized, single-center, single-blind, non-inferiority, clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drug Eluting Balloon<br>Admiral In.Pact Drug Eluting Balloon | Device: Drug Eluting Balloon Angioplasty<br>* Angioplasty with Drug eluting balloon after pre dilatation<br>* Other names: Admiral In.Pact;|
| Active Comparator: Nitinol Stent<br>Complete SE Self-expandible Nitinol stent | Device: Nitinol stenting<br>* Nitinol stent deployment<br>* Other names: Complete SE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency | Evaluations will be conducted after 3, 6 and 12 months of the procedure. The ultrasonographic evaluation of the degree of stenosis will use the Systolic Velocity Index (division of the velocity of flow at the point of greatest stenosis by the velocity of flow in normal prior segment). Rates higher than 2.4 indicate stenosis greater than 50% | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rutherford classification | Change in classification from Rutherford evaluated in 3, 6 and 12 months. | 12 months | 
| Ankle braquial Index | Change in the Ankle braquial Index evaluated in 3, 6 and 12 months | 12 months | 
| Target Lesion Revascularization | Target Lesion Revascularization rate evaluated in 3, 6 and 12 months | 12 months | 
| Stent fracture | Stent fracture rate evaluated in 3, 6 and 12 months | 12 months | 
| Amputation | Major amputation defined as amputation that requires prosthesis | 12 months | 
| Acute myocardial infarct | Acute myocardial infarct rate evaluated in 3, 6 and 12 months | 12 months | 
| Death | Death rate evaluated in 3, 6 and 12 months | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Artery, Atherosclerosis, Peripheral, Arterial, Plaque, PTA, Angioplasty, Femoropopliteal, Self Expandable Nitinol Stents