Overview

This trial is active, not recruiting.

Conditions femoral artery stenosis, popliteal artery stenosis, femoral artery occlusion, popliteal artery occlusion
Treatments drug-coated balloon (dcb), pta balloon: balloon angioplasty
Phase phase 2
Sponsor Medtronic Endovascular
Start date March 2012
End date February 2014
Trial size 331 participants
Trial identifier NCT01566461, 10031540DOC

Summary

The purpose of the study is to demonstrate the safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) in comparison to any standard balloon for treatment of peripheral arterial disease (PAD) in the superficial femoral artery and proximal popliteal artery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
IN.PACT Admiral: Balloon Angioplasty
drug-coated balloon (dcb)
Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
(Active Comparator)
Standard Percutaneous Balloon Angioplasty (PTA) Balloon: Balloon Angioplasty
pta balloon: balloon angioplasty
Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

Primary Outcomes

Measure
Primary Patency
time frame: 12 month
Primary Safety Composite
time frame: 12 month

Secondary Outcomes

Measure
Major Adverse Event (MAE) Composite
time frame: 12 month
All-cause Death
time frame: 12 month
Target Vessel Revascularization (TVR)
time frame: 12 month
Target Lesion Revascularization (TLR)
time frame: 12 month
Time to First Clinically Driven Target Lesion Revascularization (CD-TLR)
time frame: 12 month
Major Target Limb Amputation
time frame: 12 month
Thrombosis at the Target Lesion
time frame: 12 month
Primary Sustained Clinical Improvement
time frame: 12 month
Secondary Sustained Clinical Improvement
time frame: 12 month
Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >2.4)
time frame: 12 month
Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >3.4)
time frame: 12 month
Quality of Life Assessment by EuroQol Group 5-Dimension Self-Report Questionnaire (EQ5D)
time frame: 12 month
Change in Walking Distance as Assessed by Six Minute Walk Test (6MWT)
time frame: From baseline to 12 month
Walking Capacity Assessment by Walking Impairment Questionnaire (WIQ)
time frame: 12 month
Device Success
time frame: Day 1
Procedural Success
time frame: Day 1
Clinical Success
time frame: Day 1
Days of Hospitalization Due to the Index Lesion
time frame: 12 month

Eligibility Criteria

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

Inclusion Criteria: - Age: > or equal to 18 years and < or equal to 85 years - Documented ischemia with Rutherford classification 2, 3, or 4 - Target lesion in the SFA and/or PPA - Angiographic evidence that target lesion consists of a single de novo or non-stented restenotic lesion or is a combination lesion that meets the following criteria: 1. 70 - 99% occlusion by visual estimate with lesion length > or equal to 4 cm and < or equal to 18 cm 2. 100% occlusion by visual estimate with lesion length < or equal to 10 cm 3. Combination lesions must have a total lesion length of > or equal to 4 cm and < or equal to 18 cm with an occluded segment that is < or equal to 10 cm (by visual estimate) - Target vessel diameter > or equal to 4 mm and < or equal to 7 mm - Angiographic evidence of adequate distal run-off to the ankle - Able to walk without assistive devices Exclusion Criteria: - Stroke or heart attack within 3 months prior to enrollment - Enrolled in another investigational drug, device or biologic study - Any surgical procedure or intervention performed within 30 days prior to or post index procedure - SFA or PPA disease in the opposite leg that requires treatment at the index procedure - Failure to successfully cross the target lesion - Angiographic evidence of severe calcification - Target lesion requires treatment with alternative therapies such as stenting, laser, atherectomy, cryoplasty, brachytherapy, re-entry devices) - Known allergies or sensitivity to heparin, aspirin, other anticoagulant/antiplatelet therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure - Chronic kidney disease

Additional Information

Official title Randomized Trial of IN.PACT (Paclitaxel) Admiral Drug-Coated Balloon (DCB) vs. Standard Percutaneous Transluminal Angioplasty (PTA) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA)
Description The IN.PACT SFA Trial enrolled in 2 phases: IN.PACT SFA I and IN.PACT SFA II. The 150-patient IN.PACT SFA I phase is intended to support the second phase IN.PACT SFA II IDE trial with congruent design and protocol. Aggregate data from the two phases is intended to provide statistical power for the 12-month primary safety and effectiveness endpoints.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Medtronic Endovascular.