The COPPER-A Trial: The Occlusion Perfusion Catheter for Optimal Delivery of Paclitaxel for the Prevention of Endovascular Restenosis - Above and Below the Knee
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- Horizons International Peripheral Group
- Enrollment
- 112
- Locations
- 17
- Primary Endpoint
- Primary Patency
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Detailed Description
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. Subjects will be treated with the endovascular intervention selected by the treating physician in SFA reference vessels ranging from 4mm to 7mm in diameter and infrapopliteal vessels ranging from 2mm to 4mm. 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •Life expectancy \< three (3) years;
- •Planned amputation prior to procedure;
- •Pregnancy or nursing (a pregnancy test is required for all women of childbearing capabilities ≤ 7 days prior to the index procedure);
- •Previous intervention of the target lesion with a drug eluting balloon or drug delivery catheter;
- •Any treatment in the target vessel with drug eluting balloon;
- •Acute limb ischemia
- •Known allergy to paclitaxel;
- •Known hypersensitivity to other drugs manufactured in Cremophor® EL (polyoxyethylated castor oil; e.g. Drugs containing polyoxyethylated castor oil are drugs such as miconazole, cyclosporine injection, nelfinavir mesylate, saperconazole, tacrolimus, and xenaderm ointment);
- •Known allergy to anticoagulants;
- •Known TRUE acetylsalicylic acid (ASA) allergy;
Outcomes
Primary Outcomes
Primary Patency
Time Frame: 6 months
Infrapopliteal Lesions: Measured by duplex Doppler ultrasound (DUS) - demonstrated by freedom from target lesion occlusion and clinically free from Target Lesion Revascularization.
Freedom from major adverse events (MAEs)
Time Frame: 1 month
MAEs are defined as target limb related death, major amputation in the target limb (amputation above the metatarsals), or target lesion revascularization (TLR) within one (1) month.
Secondary Outcomes
- Primary Patency(12 months)
- Improvement in Rutherford category(3, 6, and 12 months)
- Primary Assisted Patency(1, 3, 6, and 12 months)
- Secondary Patency(1, 3, 6, and 12 months)
- Freedom from target lesion revascularization (TLR)(1, 3, 6, and 12 months)
- Freedom from target vessel revascularization (TVR)(1, 3, 6, and 12 months)
- Improvement in Walking Impairment Questionnaire scores(6 and 12 months)
- Device Success(Day 1 - Index Procedure)
- Freedom from major adverse events (MAEs)(1, 3, 6, and 12 months)
- Anticipated adverse events(1, 3, 6, and 12 months)