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

Horizons International Peripheral Group4 sites in 1 country11 target enrollmentMarch 11, 2015

ConditionsCardiovascular Diseases Peripheral Vascular Disease Arterial Occlusive Diseases Peripheral Arterial Disease Critical Limb Ischemia

Overview

Phase: N/A
Intervention: Not specified
Conditions: Cardiovascular Diseases
Sponsor: Horizons International Peripheral Group
Enrollment: 11
Locations: 4
Primary Endpoint: Freedom from clinically driven target lesion revascularization (CD-TLR)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 11, 2015

End Date

February 23, 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Horizons International Peripheral Group

Responsible Party

Sponsor

Eligibility Criteria

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.

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;