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

NCT02464501 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2019-11-08

No results posted yet for this study

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.

Conditions

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
2015-05-20
Primary Completion
2019-09-30
Completion
2019-11-30
FDA Device
Yes

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 NCT02464501 on ClinicalTrials.gov