Chocolate Balloon Angioplasty Registry (Chocolate BAR)

September 7, 2018 updated by: TriReme Medical, LLC
To collect data from real-world use with the Chocolate PTA Balloon Catheter to support the effectiveness of the device for use during percutaneous transluminal angioplasty (PTA) procedures.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

490

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • Arizona Heart Institute
    • California
      • Rancho Mirage, California, United States
        • Desert Cardiology
    • Florida
      • Gainesville, Florida, United States
        • Cardiovascular Research of North Florida
      • Miami, Florida, United States
        • Mount Sinai Medical Center
    • Illinois
      • Elk Grove Village, Illinois, United States
        • Alexian Brothers Heart and Vascular
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • St. Elizabeth's Medical Center
    • Michigan
      • Detroit, Michigan, United States
        • St. John's Hospital
      • Wyoming, Michigan, United States, 49519
        • Metro Health Hospital
    • Mississippi
      • Jackson, Mississippi, United States
        • Jackson Heart Clinic
    • North Carolina
      • Raleigh, North Carolina, United States
        • Rex Health
    • Texas
      • Dallas, Texas, United States
        • Cardiovascular Research of Dallas
      • Dallas, Texas, United States
        • VA North Texas
    • Wisconsin
      • Racine, Wisconsin, United States
        • Wheaton Franciscan Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Peripheral Arterial Disease appropriate for treatment with balloon angioplasty

Description

Inclusion Criteria:

  1. >18 years of age
  2. Lesion successfully crossed with a guide-wire
  3. Reference Vessel Diameter (RVD) within the treatment range of the Chocolate PTA Catheter used at the target lesion appropriate for 1:1 dilatation
  4. Patient has given consent for their information to be submitted to this registry

Exclusion Criteria:

  1. Lesion required stenting as the primary treatment approach
  2. Life expectancy <12 months
  3. Patient is enrolled in another clinical study that may impact the results of this registry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Above the Knee
Patients treated with the Chocolate balloon for a lesion located above the knee
Below the Knee
Patients treated with the Chocolate balloon for a lesion located below the knee

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achievement of Optimal PTA
Time Frame: average of 2 hours
Percentage of PTA cases in which <30% diameter stenosis without a flow limiting dissection is achieved without the need for bail-out stenting
average of 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TriReme Medical, LLC

Investigators

  • Principal Investigator: Lawrence Garcia, MD, St Elizabeth's Med Center / Tufts Univ School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 27, 2012

First Submitted That Met QC Criteria

April 30, 2012

First Posted (Estimate)

May 1, 2012

Study Record Updates

Last Update Posted (Actual)

September 11, 2018

Last Update Submitted That Met QC Criteria

September 7, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLP782

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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