Overview

This trial is active, not recruiting.

Condition peripheral arterial disease
Treatment in.pact admiral™ drug eluting balloon
Phase phase 4
Sponsor Medtronic Endovascular
Start date May 2012
End date April 2016
Trial size 1538 participants
Trial identifier NCT01609296, 10048613

Summary

The purpose of this study is to collect safety and efficacy data on the IN.PACT Admiral™ Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial femoral and/or popliteal arteries in a "real world" patient population.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
The subjects in this trial will be treated with the IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon (hereinafter referred as "IN.PACT Admiral™ DEB")manufactured by Medtronic. The IN.PACT Admiral™ is a CE (Conformité Europeénne, European Confirmity) marked medical device utilized within its intended use in the IN.PACT Global trial.
in.pact admiral™ drug eluting balloon
IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon.

Primary Outcomes

Measure
Primary Endpoint Clinical Cohort
time frame: 12 months
Primary Endpoint Imaging Cohort
time frame: 12 months
Primary Safety Endpoint
time frame: 12 months

Secondary Outcomes

Measure
MAEs
time frame: 30 days, 6, 12, 24, 36, 48 and 60 months
All-cause mortality
time frame: at 30 days, 6, 12, 24, 36, 48 and 60 months.
Clinically-driven TLR
time frame: at 30 days, 6, 24, 36, 48 and 60 months.
Clinically-driven TVR
time frame: at 30 days, 6, 12, 24, 36, 48 and 60 months.
TLR
time frame: at 6, 12, 24, 36, 48 and 60 months
TVR
time frame: at 6, 12, 24, 36, 48 and 60 months.
Major target limb amputation
time frame: at 30 days, 6, 12, 24, 36, 48 and 60 months.
Time to first clinically-driven TLR
time frame: through 60 months post-index procedure.
Time to all-cause mortality
time frame: through 60 months post-index procedure.
Primary sustained clinical improvement
time frame: at 6, 12, 24, 36 months.
Secondary sustained clinical improvement
time frame: at 6, 12, 24, 36 months.
Immediate hemodynamic improvement
time frame: at post-index procedure.
Sustained hemodynamic improvement
time frame: at 6, 12, 24, 36 months.
Walking impairment evaluation by Walking Impairment Questionnaire (WIQ)
time frame: at 6, 12, 24, 36 months.
Walking distance as measured by 6 Minute Walk Test
time frame: at 6, 12, 24, 36 months.
Health related Quality of life scores (EQ5D)
time frame: at 6, 12, 24, 36 months
Device success
time frame: Index-procedure
Clinical success
time frame: prior to discharge
Imaging cohort: Duplex-defined binary restenosis (PSVR > 2.0) of the target lesion
time frame: at 12 months, or at the time of re-intervention.
Imaging cohort: 21. Duplex-defined binary restenosis (PSVR > 3.4) of the target lesion
time frame: at 12 months, or at the time of re-intervention.

Eligibility Criteria

Male or female participants at least 18 years old.

General inclusion Criteria: - Age ≥ 18 years or minimum age as required by local regulations. - Subject with documented diagnosis of peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and/or popliteal artery (PA) (including P1, P2, P3) classified as Rutherford class 2-3-4. - Angiographically documented single or multiple lesions/occlusions (de novo or re-stenotic lesion(s) or in-stent restenosis) within the target vessels with a minimum lesion length of 2 cm including bilateral disease if both limbs are treated within 35 days. General exclusion Criteria: - High probability of non-adherence to Clinical Investigation Protocol follow-up requirements. - Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations). - Lesion within or adjacent to an aneurysm or presence of a popliteal aneurysm.

Additional Information

Official title The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral™ Drug-Eluting Balloon.
Principal investigator Gunnar Tepe, MD
Description Peripheral artery disease (PAD) commonly results from progressive narrowing of the arteries in the lower extremities, usually due to atherosclerosis. Progression of PAD can result in critical limb ischemia(CLI), manifested by ischemic pain at rest or in the breakdown of the skin, resulting in ulcers or gangrene which ultimately may lead to amputation and death. The IN.PACT Global Clinical Study aims to expand and understand the safety and efficacy data on the IN.PACT Admiral™ DEB in a real world population of subjects with intermittent claudication and/or rest pain (Rutherford class 2-3-4) due to obstructive disease of the superficial femoral and/or popliteal arteries.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Medtronic Endovascular.