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

Instituto Dante Pazzanese de Cardiologia

Status and phase

Completed

Phase 4

Conditions

Paclitaxel

Peripheral Vascular Diseases

Critical Limb Ischemia

Arterial Occlusive Diseases

Cardiovascular Diseases

Arteriosclerosis

Peripheral Arterial Disease

Atherosclerosis

Plaque, Atherosclerotic

Treatments

Device: Nitinol stenting

Device: Drug Eluting Balloon Angioplasty

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02212470

IDPC_3 2014

Details and patient eligibility

About

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.

Enrollment

85 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)