The COPPER-B Trial

Cardiovascular Diseases Clinical Trial

— COPPER-B  

Official title:

The Occlusion Perfusion Catheter for Optimal Delivery of Paclitaxel for the Prevention of Endovascular Restenosis - Below the Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02395744
• Other study ID #: HIPG-CLIN-2015-01
• Status: Completed
• Phase: N/A
• First received: March 12, 2015
• Last updated: February 24, 2017
• Start date: March 11, 2015
• Est. completion date: February 23, 2017

Study information

• Verified date: February 2017
• Source: Horizons International Peripheral Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 23, 2017
• Est. primary completion date: August 15, 2016
• 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 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 Exclusion Criteria

• Flow limiting dissection requiring stent placement;

• Post PTA residual stenosis > 30% as visualized by treating physician;

• Perforation requiring a covered stent;

• Lesion is above the trifurcation;

• In-stent restenosis in target vessel;

• Significant (= 50% DS) inflow lesion or occlusion left untreated in the ipsilateral Iliac, SFA, or popliteal artery proximal to the target lesion;

• Lesions in the target vessel not treated with the OPC;

• Visible thrombus in the target artery or proximal to the target artery.

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Cardiovascular Diseases
• Critical Limb Ischemia
• Ischemia
• 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	Michigan Outpatient Vascular Institute	Dearborn	Michigan
United States	Cardiology Associates	Fairhope	Alabama
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	Cardiovascular Associates of East Texas	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	Freedom from clinically driven target lesion revascularization (CD-TLR)		6 months
Primary	Freedom from major adverse events (MAEs)		6 months
Secondary	Device success		Index Procedure
Secondary	Improvement in Rutherford category		6 Months
Secondary	Improvement in ABI		6 months
Secondary	Freedom from Target Vessel Revascularization		6 Months
Secondary	Improvement in wound healing		6 months
Secondary	Device or procedure related serious adverse events (SAEs)		1 month
Secondary	Treatment related anticipated adverse events (AEs)		1, 3, and 6 months
Secondary	Treatment related serious adverse events (SAEs)		3 and 6 months