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Understanding Angioplasty by the Chocolate PTA Balloon Catheter Compared to Conventional PTA Balloons Via OCT Imaging

NCT02237066 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-03-19

No results posted yet for this study

Summary

The purpose of this study is to compare the Chocolate PTA Balloon to standard Percutaneous Transluminal Angioplasty (PTA) catheters. The investigators will use Optical Coherence Tomography (OCT) and Quantitative Vascular Angiography to evaluate the acute vascular response of vessels treated with the Chocolate Balloon to a standard balloon catheter, with the primary endpoint being luminal gain assessed by OCT lumen volume measurements.

Conditions

  • Infrainguinal Peripheral Arterial Disease

Interventions

DEVICE

Chocolate PTA Balloon Angioplasty

OCT imaging of diseased vessel is treated with an Angioplasty Procedure using the Chocolate PTA Balloon Catheter followed by OCT imaging of the treated area immediately after balloon use and 10 minutes later

DEVICE

Standard PTA Balloon Angioplasty

OCT imaging of diseased vessel is treated with an Angioplasty Procedure using a standard PTA Balloon Catheter followed by OCT imaging of the treated area immediately after balloon use and 10 minutes later

Sponsors & Collaborators

  • University Hospitals Cleveland Medical Center

    collaborator OTHER

  • TriReme Medical, LLC

    lead INDUSTRY

Principal Investigators

  • Sahil A Parikh, MD · Harrington Heart and Vascular Institute University Hospitals Case Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

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 NCT02237066 on ClinicalTrials.gov