Arterial Occlusive Diseases, Cardiovascular Diseases, Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
Conditions
Brief summary
The purpose of the COPPER - B study is to assess the feasibility, safety, and initial efficacy of paclitaxel administration using the OPC for the prevention of restenosis in infrapopliteal de novo and restenotic lesions and occlusions using a novel catheter, the OPC.
Interventions
Sponsors
Advanced Catheter Therapies, Inc.
Horizons International Peripheral Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria: * Willing and able to provide informed consent and comply with all study requirements; * Candidate for an infrapopliteal percutaneous intervention; * Must be ≥ 18 years of age; * Rutherford category 3-6; * Willing and able to tolerate dual anti-platelet therapy (DAPT) for a minimum of one (1) month; * Labwork within acceptable limits according to standard of care; * INR \< 2.0 if on warfarin or not on warfarin; * Sheath size used for the interventional procedure 6F, 7F, or 8F. General
Exclusion criteria
* Life expectancy \< one (1) year; * 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 vessel with a drug eluting balloon, or drug delivery catheter; * 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; * Use of glycoprotein (GP) IIb/IIIa inhibitors during the procedure visit within 30 days prior to the index procedure; * Target lesion treated with a cryoplasty balloon at the time of the index procedure; * Current enrollment in another investigational device or drug study; * After obtaining informed consent, at any point up to introduction of the OPC, the investigator determines the study subject is not appropriate for the study; * Hemorrhagic stroke within three (3) months; * Renal failure or chronic kidney disease with GFR ≤30 ml/min or MDRD GFR ≤30 ml/min per 1.73 m2 (or serum creatinine ≥2.5 mg/L within 30 days of index procedure or patient is on dialysis); * Prior vascular surgery of the index limb. Angiographic Inclusion Criteria * Reference vessel diameter (RVD) ≥ 2mm and ≤ 4mm; * Single or multiple lesions in the infrapopliteal arteries (AT, PT, peroneal); * If single lesion treatment, the minimum lesion length required is 2cm; * Lesion location must in the area from the origin of the trifurcation vessel to the ankle (top of the talus bone); * Minimum of one vessel run-off; * Pre-intervention percent DS ≥ 70%; * Target vessel reconstitutes at/above the ankle; * Infrapopliteal treatment prior to infrapopliteal OPC treatment resulting in ≤ 30% residual stenosis; * Infrapopliteal interventional treatment length is within the area of 1cm below the level of the knee joint to the malleolus, except in the case where an anomalous take-off of an infrapopliteal artery comes of at mid-knee joint. Angiographic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from clinically driven target lesion revascularization (CD-TLR) | 6 months |
| Freedom from major adverse events (MAEs) | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in ABI | 6 months |
| Freedom from Target Vessel Revascularization | 6 Months |
| Improvement in wound healing | 6 months |
| Device success | Index Procedure |
| Treatment related anticipated adverse events (AEs) | 1, 3, and 6 months |
| Treatment related serious adverse events (SAEs) | 3 and 6 months |
| Device or procedure related serious adverse events (SAEs) | 1 month |
| Improvement in Rutherford category | 6 Months |
Countries
United States
Outcome results
None listed