The COPPER-A Trial: The Occlusion Perfusion Catheter for Optimal Delivery of Paclitaxel for the Prevention of Endovascular Restenosis - Above and Below the Knee

Status: Completed
Location: See all (17) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to assess the safety and efficacy of paclitaxel administration using the occlusion perfusion catheter (OPC) for the prevention of restenosis in infrainguinal de novo, restenotic femoropopliteal and infrapopliteal stenoses and occlusions, and in-stent restenosis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Willing and able to provide informed consent and comply with all study requirements;

• Candidate for peripheral vascular femoropopliteal or infrapopliteal percutaneous intervention;

• Must be ≥ 18 years of age;

• Rutherford category 2, 3, 4, or 5;

• Willing and able to tolerate dual anti-platelet therapy (DAPT) for a minimum of one (1) month;

• Lab work within acceptable limits according to standard of care;

• INR < 2.0 if on warfarin or not on warfarin;

• Minimum sheath size used for the interventional procedure

• 7x8 OPC Catheter - 7FR.

• 3x15 OPC, 3x15 PRESSANA(TM), or 3x8 PRESSANA(TM) - 6FR.

Locations
United States
Alabama
Cardiology Associates
Fairhope
Florida
First Coast Cardiovascular Institute
Jacksonville
Coastal Vascular and Interventional
Pensacola
Iowa
Vascular Institute of the Midwest
Davenport
Louisiana
Cardiovascular Institute of the South
Houma
Michigan
Michigan Outpatient Vascular Institute
Dearborn
St. John Hospital
Detroit
Mid-Michigan Heart & Vascular Center
Saginaw
Mississippi
Hattiesburg Clinic
Hattiesburg
North Carolina
Novant Health
Charlotte
South Carolina
Medical University of South Carolina
Charleston
Tennessee
University Surgical Associates
Chattanooga
Kore Cardiovascular Research
Jackson
Texas
Huntsville Memorial Hospital
Huntsville
North Dallas Research Associates
Mckinney
Cardiovascular Associates of East Texas
Tyler
Tyler Cardiovascular Consultants
Tyler
Time Frame
Start Date: May 20, 2015
Completion Date: November 2019
Participants
Target number of participants: 112
Treatments
Experimental: OPC Treatment
Paclitaxel administration using the OPC for the prevention of restenosis in infrainguinal de novo and restenotic femoropopliteal lesions. Subjects will be treated with the endovascular intervention selected by the treating physician in reference vessels ranging from 4mm to 7mm in diameter. Following the achievement of optimal interventional results (less than thirty (30) percent residual stenosis without stenting) the OPC will be placed at the interventional treatment area and paclitaxel will be delivered to the treated segment. Data will be collected to assess acute safety, long-term safety and durability to demonstrate the safety and efficacy of paclitaxel delivered with the ACT, Inc. OPC device.
Sponsors
Leads: Horizons International Peripheral Group
Collaborators: Advanced Catheter Therapies, Inc.

This content was sourced from clinicaltrials.gov

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