Clinical trial NCT02464501: The OPC for Optimal Delivery of Paclitaxel for the Prevention of Endovascular Restenosis - Above and Below the Knee
Official title: The COPPER-A Trial: The Occlusion Perfusion Catheter for Optimal Delivery of Paclitaxel for the Prevention of Endovascular Restenosis - Above and Below the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Cardiovascular Disease
Peripheral Vascular Disease
Keywords: PAD
COPPER-A
Peripheral Arterial Disease
OPC
Occlusion Perfusion Catheter
Paclitaxel
Pressana
Precision Delivery System
Lead sponsor: Horizons International Peripheral Group
Sponsor class: OTHER
Collaborators: name: Advanced Catheter Therapies, Inc.
First posted: 2015-06-08
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: General 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.

General 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;
* Use of glycoprotein (GP) IIb/IIIa inhibitors during the procedure visit within 30 days following the index procedure;
* Target lesion treated with a cryoplasty balloon at the time of the index procedure;
* Hemorrhagic stroke within six (6) 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 treated with dialysis);
* Prior vascular surgery of the index limb;
* 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.

Angiographic Inclusion Criteria:

* Reference vessel diameter (RVD) ≥ 4 mm and ≤ 7 mm for femoropopliteal arteries or ≥ 2 mm and ≤ 4 mm for infrapopliteal arteries;
* Either single or multiple lesions in the SFA and/or popliteal artery or single or multiple lesions in the infrapopliteal arteries (AT, PT, peroneal);
* For single lesion treatment, minimum lesion length ≥ 20 mm;
* Minimum of one patent infrapopliteal vessel;
* Pre-intervention percent DS ≥ 70%.

Angiographic Exclusion Criteria:

* Flow limiting dissection necessitating stent placement prior to OPC use;
* Post PTA residual stenosis ≥ 30% as visualized by treating physician;
* Perforation requiring a covered stent;
* For femoropopliteal target lesion or occlusion location extends distally beyond the P2 region of the popliteal artery or infrapopliteal lesion or occlusion location is at or proximal to the origin of the trifurcation vessel or below the ankle (top of the talus bone);
* Target lesion within a fractured stent;
* Target lesion within a stent and restenosed two (2) or more times;
* Significant (≥ 50% DS) inflow lesion or occlusion left untreated in the ipsilateral Iliac, SFA, or popliteal artery proximal to the target lesion;
* A lesion treated distal to the target lesion results in compromising inline flow distal to the target lesion;
* Visible thrombus in the target artery or proximal to the target artery.

Primary outcomes:
measure: Primary Patency
timeFrame: 12 months
measure: Primary Patency
timeFrame: 6 months
measure: Freedom from major adverse events (MAEs)
timeFrame: 1 month
Secondary outcomes:
measure: Primary Patency
timeFrame: 6 months
measure: Primary Patency
timeFrame: 12 months
measure: Improvement in Rutherford category
timeFrame: 3, 6, and 12 months
measure: Primary Assisted Patency
timeFrame: 1, 3, 6, and 12 months
measure: Secondary Patency
timeFrame: 1, 3, 6, and 12 months
measure: Freedom from target lesion revascularization (TLR)
timeFrame: 1, 3, 6, and 12 months
measure: Freedom from target vessel revascularization (TVR)
timeFrame: 1, 3, 6, and 12 months
measure: Improvement in Walking Impairment Questionnaire scores
timeFrame: 6 and 12 months
measure: Device Success
timeFrame: Day 1 - Index Procedure
measure: Freedom from major adverse events (MAEs)
timeFrame: 1, 3, 6, and 12 months
measure: Anticipated adverse events
timeFrame: 1, 3, 6, and 12 months
Other outcomes:
Locations:
city: Fairhope
country: United States
facility: Cardiology Associates
state: Alabama
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: Pensacola
country: United States
facility: Coastal Vascular and Interventional
state: Florida
city: Davenport
country: United States
facility: Vascular Institute of the Midwest
state: Iowa
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Dearborn
country: United States
facility: Michigan Outpatient Vascular Institute
state: Michigan
city: Detroit
country: United States
facility: St. John Hospital
state: Michigan
city: Saginaw
country: United States
facility: Mid-Michigan Heart & Vascular Center
state: Michigan
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: Charlotte
country: United States
facility: Novant Health
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Chattanooga
country: United States
facility: University Surgical Associates
state: Tennessee
city: Jackson
country: United States
facility: Kore Cardiovascular Research
state: Tennessee
city: Huntsville
country: United States
facility: Huntsville Memorial Hospital
state: Texas
city: McKinney
country: United States
facility: North Dallas Research Associates
state: Texas
city: Tyler
country: United States
facility: Cardiovascular Associates of East Texas
state: Texas
city: Tyler
country: United States
facility: Tyler Cardiovascular Consultants
state: Texas
Study officials:
affiliation: Cardiology Associates
name: Frank Bunch, MD, FACC
role: PRINCIPAL_INVESTIGATOR
References: