Chocolate Balloon Angioplasty Registry (Chocolate BAR)
![]() |
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. |
ClinicalTrials.gov Identifier: NCT01589042 |
Recruitment Status :
Completed
First Posted : May 1, 2012
Last Update Posted : September 11, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Peripheral Arterial Disease |
Study Type : | Observational |
Actual Enrollment : | 490 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Chocolate Balloon Angioplasty Registry |
Study Start Date : | May 2012 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | December 2015 |
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
|
- 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

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, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- >18 years of age
- Lesion successfully crossed with a guide-wire
- Reference Vessel Diameter (RVD) within the treatment range of the Chocolate PTA Catheter used at the target lesion appropriate for 1:1 dilatation
- Patient has given consent for their information to be submitted to this registry
Exclusion Criteria:
- Lesion required stenting as the primary treatment approach
- Life expectancy <12 months
- Patient is enrolled in another clinical study that may impact the results of this registry

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 |
Principal Investigator: | Jihad Mustapha, MD | Metro Health Hospital | |
Principal Investigator: | Lawrence Garcia, MD | St Elizabeth's Med Center / Tufts Univ School of Medicine |
Responsible Party: | TriReme Medical, LLC |
ClinicalTrials.gov Identifier: | NCT01589042 |
Other Study ID Numbers: |
CLP782 |
First Posted: | May 1, 2012 Key Record Dates |
Last Update Posted: | September 11, 2018 |
Last Verified: | September 2018 |
Peripheral Arterial Disease Peripheral Vascular Diseases Atherosclerosis Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |