Drug Eluting Balloon in peripherAl inTErvention: the DEBATE SFA Study

Leonardo Bolognese, MD1 site in 1 country104 target enrollmentNovember 2010

ConditionsPeripheral Arterial Disease

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Peripheral Arterial Disease
Sponsor: Leonardo Bolognese, MD
Enrollment: 104
Locations: 1
Primary Endpoint: angiographic binary restenosis
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed by nitinol stent implantation versus nitinol stent implantation in superficial femoral artery and popliteal artery stenosis.

Registry

clinicaltrials.gov

Start Date

November 2010

End Date

September 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Leonardo Bolognese, MD

Responsible Party

Sponsor Investigator

Principal Investigator

Leonardo Bolognese, MD

Director of Cardiovascular Department

Ospedale San Donato

Eligibility Criteria

Inclusion Criteria

•age\>18 years
•intermittent claudication(Fontane III or IV)
•angiographic stenosis\>50% or occlusion of superficial femoral-popliteal artery\>40mm
•at least one below-knee vessel to the ankle