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Drug-Coated Chocolate PTA Balloon in Patients With Peripheral Arterial Disease - The ENDURE Trial

NCT02129127 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2017-04-14

No results posted yet for this study

Summary

This first-in-man study is to evaluate the Drug-Coated Chocolate (DCC) Balloon for percutaneous arterial angioplasty in patients with symptomatic peripheral arterial disease. The study focuses on acute device performance and peri-procedural safety and also seeks to further characterize the performance of the device.

Conditions

  • Peripheral Vascular Disease

Interventions

DEVICE

Paclitaxel Coated Chocolate Balloon Angioplasty

Balloon Angioplasty with the Chocolate Balloon resulting in vessel dilatation and localized delivery of Paclitaxel

Sponsors & Collaborators

  • TriReme Medical, LLC

    lead INDUSTRY

Principal Investigators

  • Andrew Holden, MD · Auckland City Hospital

  • Thomas Zeller, MD · Universitats Herzzentrum Bad Krozingen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-06-30
Completion
2017-04-30

Countries

  • Germany
  • New Zealand

Study Locations

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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 NCT02129127 on ClinicalTrials.gov