The COPPER-B Trial

NCT02395744 | Completed

• 1 other identifier: HIPG-CLIN-2015-01
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 4

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.

Conditions

Cardiovascular Diseases; Peripheral Vascular Disease; Arterial Occlusive Diseases; Peripheral Arterial Disease; Critical Limb Ischemia

Outcome Measures

Primary Outcomes (2)

• Freedom from clinically driven target lesion revascularization (CD-TLR)

  6 months

• Freedom from major adverse events (MAEs)

  6 months

Secondary Outcomes (8)

• Device success

  Index Procedure

• Improvement in Rutherford category

  6 Months

• Improvement in ABI

  6 months

• Freedom from Target Vessel Revascularization

  6 Months

• Improvement in wound healing

  6 months

Study Arms (1)

OPC Treatment

EXPERIMENTAL

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. Subjects will be treated with the endovascular intervention selected by the treating physician in reference vessels ranging from 2mm to 4mm in diameter. Following the achievement of optimal interventional results (≤ 30 percent residual stenosis without stenting and without flow-limiting dissection) the OPC will be placed at the interventional treatment area and paclitaxel will be delivered to the treated segment.

Other: Paclitaxel administration using the OPC

Interventions

Paclitaxel administration using the OPC OTHER

OPC Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Horizons International Peripheral Group: lead
• Advanced Catheter Therapies, Inc.: collaborator

Study Sites (4)

Cardiology Associates

Fairhope, Alabama, 36532, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70361, United States

Location

Michigan Outpatient Vascular Institute

Dearborn, Michigan, 48124, United States

Location

Cardiovascular Associates of East Texas

Tyler, Texas, 75701, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Peripheral Vascular Diseases; Arterial Occlusive Diseases; Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Vascular Diseases; Atherosclerosis; Arteriosclerosis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Frank Bunch, MD, FACC

  Cardiology Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: March 24, 2015
• Study Start: March 11, 2015
• Primary Completion: August 15, 2016
• Study Completion: February 23, 2017
• Last Updated: February 27, 2017

Record last verified: 2017-02

Locations

US (4)