The COPPER-B Trial

NCT02395744 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2017-02-27

No results posted yet for this study

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

Interventions

OTHER

Paclitaxel administration using the OPC

Sponsors & Collaborators

  • Advanced Catheter Therapies, Inc.

    collaborator INDUSTRY
  • Horizons International Peripheral Group

    lead OTHER

Principal Investigators

  • Frank Bunch, MD, FACC · Cardiology Associates

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-11
Primary Completion
2016-08-15
Completion
2017-02-23

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02395744 on ClinicalTrials.gov