Chocolate Balloon Angioplasty Registry
Chocolate BAR
1 other identifier
observational
490
1 country
13
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2012
Typical duration for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2012
CompletedFirst Posted
Study publicly available on registry
May 1, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedSeptember 11, 2018
September 1, 2018
3.6 years
April 27, 2012
September 7, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Achievement of Optimal PTA
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
Study Arms (2)
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
Eligibility Criteria
Patients with Peripheral Arterial Disease appropriate for treatment with balloon angioplasty
You may qualify if:
- \>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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Arizona Heart Institute
Phoenix, Arizona, United States
Desert Cardiology
Rancho Mirage, California, United States
Cardiovascular Research of North Florida
Gainesville, Florida, United States
Mount Sinai Medical Center
Miami, Florida, United States
Alexian Brothers Heart and Vascular
Elk Grove Village, Illinois, United States
St. Elizabeth's Medical Center
Boston, Massachusetts, 02135, United States
St. John's Hospital
Detroit, Michigan, United States
Metro Health Hospital
Wyoming, Michigan, 49519, United States
Jackson Heart Clinic
Jackson, Mississippi, United States
Rex Health
Raleigh, North Carolina, United States
Cardiovascular Research of Dallas
Dallas, Texas, United States
VA North Texas
Dallas, Texas, United States
Wheaton Franciscan Healthcare
Racine, Wisconsin, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jihad Mustapha, MD
Metro Health Hospital
- PRINCIPAL INVESTIGATOR
Lawrence Garcia, MD
St Elizabeth's Med Center / Tufts Univ School of Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2012
First Posted
May 1, 2012
Study Start
May 1, 2012
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
September 11, 2018
Record last verified: 2018-09