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

Instituto Dante Pazzanese de Cardiologia1 site in 1 country85 target enrollmentJuly 2014

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

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Peripheral Arterial Disease
Sponsor: Instituto Dante Pazzanese de Cardiologia
Enrollment: 85
Locations: 1
Primary Endpoint: Primary patency
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 2014

End Date

October 2019

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Instituto Dante Pazzanese de Cardiologia

Responsible Party

Principal Investigator

Fabio H Rossi

MD, PHD

Instituto Dante Pazzanese de Cardiologia

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Primary patency

Time Frame: 12 months

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%