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Chocolate Balloon Angioplasty Registry (Chocolate BAR)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: May 1, 2012
Last Update Posted: June 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
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.

Peripheral Arterial Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chocolate Balloon Angioplasty Registry

Resource links provided by NLM:

Further study details as provided by TriReme Medical, LLC:

Primary Outcome Measures:
  • 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

Enrollment: 490
Study Start Date: May 2012
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Peripheral Arterial Disease appropriate for treatment with balloon angioplasty

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01589042

United States, Arizona
Arizona Heart Institute
Phoenix, Arizona, United States
United States, California
Desert Cardiology
Rancho Mirage, California, United States
United States, Florida
Cardiovascular Research of North Florida
Gainesville, Florida, United States
Mount Sinai Medical Center
Miami, Florida, United States
United States, Illinois
Alexian Brothers Heart and Vascular
Elk Grove Village, Illinois, United States
United States, Massachusetts
St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
United States, Michigan
St. John's Hospital
Detroit, Michigan, United States
Metro Health Hospital
Wyoming, Michigan, United States, 49519
United States, Mississippi
Jackson Heart Clinic
Jackson, Mississippi, United States
United States, North Carolina
Rex Health
Raleigh, North Carolina, United States
United States, Texas
Cardiovascular Research of Dallas
Dallas, Texas, United States
VA North Texas
Dallas, Texas, United States
United States, Wisconsin
Wheaton Franciscan Healthcare
Racine, Wisconsin, United States
Sponsors and Collaborators
TriReme Medical, LLC
Principal Investigator: Jihad Mustapha, MD Metro Health Hospital
Principal Investigator: Lawrence Garcia, MD St Elizabeth's Med Center / Tufts Univ School of Medicine
  More Information

Responsible Party: TriReme Medical, LLC
ClinicalTrials.gov Identifier: NCT01589042     History of Changes
Other Study ID Numbers: CLP782
First Submitted: April 27, 2012
First Posted: May 1, 2012
Last Update Posted: June 3, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases