Overview

This trial is active, not recruiting.

Condition peripheral arterial disease (pad)
Treatments drug eluting balloon, standard percutaneous transluminal angioplasty (pta) balloon
Sponsor Medtronic Endovascular
Start date September 2010
End date February 2014
Trial size 150 participants
Trial identifier NCT01175850, P990

Summary

The objective of this Study is to evaluate the safety and efficacy of the IN.PACT Admiral(TM) drug eluting PTA balloon, utilized for the dilatation of the narrowed sections of the artery, as compared to other standard (non drug eluting) PTA balloons. The IN.PACT Admiral(TM), besides the mechanical dilatation effect typical of all PTA balloons, releases a drug (paclitaxel) from the balloon surface into the vessel walls. This drug absorption is intended to limit the chances and the entity of artery re-narrowing over time.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
drug eluting balloon
balloon dilatation and provisional stenting with IN.PACT DEB
(Active Comparator)
standard percutaneous transluminal angioplasty (pta) balloon
balloon dilatation and provisional stenting with standard non-coated PTA balloon

Primary Outcomes

Measure
Primary Efficacy
time frame: 12 Months
Primary Safety
time frame: 30 days

Secondary Outcomes

Measure
Secondary Safety Endpoint
time frame: 60 Months

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

General Inclusion Criteria: - Age ≥18 years and ≤85 years - Patient or patient's legal representative is informed of the nature of the study, agrees to participate and has signed an EC approved consent form Angiographic Inclusion Criteria: - Target vessel is the superficial femoral artery and/or proximal popliteal artery (above the knee) General Exclusion Criteria: - Patient unwilling or unlikely to comply with follow-up schedule - Stroke or STEMI within 3 months prior enrolment Angiographic Exclusion Criteria: - Acute or sub-acute thrombus in the target vessel

Additional Information

Official title Randomized Trial of IN.PACT Admiral(TM) Drug Eluting Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease
Principal investigator Gunnar Tepe, Prof Dr. Med
Description The efficacy of the IN.PACT Admiral(TM) balloon will be evaluated by assessing the primary patency rate of the treated arteries in the thighs of all patients included in the Study. Primary patency is a measure of the durability up to 1 year of the free lumen in the artery as restored during the procedure and is based on: - the need for re-dilatation of the previously treated vessel segment - an ultrasound examination The safety of the IN.PACT Admiral(TM) will be assessed by evaluating the incidence of deaths, amputations and re-dilatation of the pre-treated arteries in all patients included in the Study.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Medtronic Endovascular.