The OPC for Optimal Delivery of Paclitaxel for the Prevention of Endovascular Restenosis - Above and Below the Knee

Cardiovascular Disease Clinical Trial

— COPPER-A  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02464501
• Other study ID #: HIPG-CLIN-2015-02
• Status: Completed
• Phase: N/A
• Start date: May 20, 2015
• Est. completion date: November 2019

Study information

• Verified date: November 2019
• Source: Horizons International Peripheral Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: November 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Other:
• Paclitaxel administration using the OPC

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Novant Health	Charlotte	North Carolina
United States	University Surgical Associates	Chattanooga	Tennessee
United States	Vascular Institute of the Midwest	Davenport	Iowa
United States	Michigan Outpatient Vascular Institute	Dearborn	Michigan
United States	St. John Hospital	Detroit	Michigan
United States	Cardiology Associates	Fairhope	Alabama
United States	Hattiesburg Clinic	Hattiesburg	Mississippi
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	Huntsville Memorial Hospital	Huntsville	Texas
United States	Kore Cardiovascular Research	Jackson	Tennessee
United States	First Coast Cardiovascular Institute	Jacksonville	Florida
United States	North Dallas Research Associates	McKinney	Texas
United States	Coastal Vascular and Interventional	Pensacola	Florida
United States	Mid-Michigan Heart & Vascular Center	Saginaw	Michigan
United States	Cardiovascular Associates of East Texas	Tyler	Texas
United States	Tyler Cardiovascular Consultants	Tyler	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Horizons International Peripheral Group	Advanced Catheter Therapies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Patency	Femoropopliteal Lesions: Measured by duplex Doppler ultrasound (DUS) - demonstrated by Peak Systolic Velocity Ratio (PSVR) = 2.5 and clinically free from Target Lesion Revascularization.	12 months
Primary	Primary Patency	Infrapopliteal Lesions: Measured by duplex Doppler ultrasound (DUS) - demonstrated by freedom from target lesion occlusion and clinically free from Target Lesion Revascularization.	6 months
Primary	Freedom from major adverse events (MAEs)	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.	1 month
Secondary	Primary Patency	Femoropopliteal Lesions: Measured by duplex Doppler ultrasound (DUS) - demonstrated by Peak Systolic Velocity Ratio (PSVR) = 2.5 and clinically free from Target Lesion Revascularization.	6 months
Secondary	Primary Patency	Infrapopliteal Lesions: Measured by duplex Doppler ultrasound (DUS) - demonstrated by freedom from target lesion occlusion and clinically free from Target Lesion Revascularization.	12 months
Secondary	Improvement in Rutherford category		3, 6, and 12 months
Secondary	Primary Assisted Patency	Patency of the target lesion following endovascular re-intervention of the target lesion due to symptomatic restenosis.	1, 3, 6, and 12 months
Secondary	Secondary Patency	Measured by patency of the target lesion after treatment of a (re)occlusion of the index lesion during the follow-up period.	1, 3, 6, and 12 months
Secondary	Freedom from target lesion revascularization (TLR)		1, 3, 6, and 12 months
Secondary	Freedom from target vessel revascularization (TVR)		1, 3, 6, and 12 months
Secondary	Improvement in Walking Impairment Questionnaire scores		6 and 12 months
Secondary	Device Success	Defined as the ability to deliver paclitaxel to the interventional treatment length as intended.	Day 1 - Index Procedure
Secondary	Freedom from major adverse events (MAEs)		1, 3, 6, and 12 months
Secondary	Anticipated adverse events		1, 3, 6, and 12 months