Chocolate Balloon Angioplasty Registry (Chocolate BAR)
This study is currently recruiting participants.
Verified December 2012 by TriReme Medical, Inc.
Sponsor:
TriReme Medical, Inc.
Information provided by (Responsible Party):
TriReme Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01589042
First received: April 27, 2012
Last updated: December 5, 2012
Last verified: December 2012
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Purpose
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.
| Condition |
|---|
|
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, Inc.:
Primary Outcome Measures:
- Achievement of Optimal PTA [ Time Frame: average of 2 hours ] [ Designated as safety issue: Yes ]Percentage of PTA cases in which <30% diameter stenosis without a flow limiting dissection is achieved without the need for bail-out stenting
| Estimated Enrollment: | 200 |
| Study Start Date: | May 2012 |
| Groups/Cohorts |
|---|
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with Peripheral Arterial Disease appropriate for treatment with balloon angioplasty
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589042
Contacts
| Contact: Erin Tims, MS | 925-931-1300 ext 212 | etims@trirememedical.com |
Locations
| United States, Arizona | |
| Arizona Heart Institute | Recruiting |
| Phoenix, Arizona, United States | |
| Principal Investigator: Venkatesh Ramiah, MD | |
| United States, California | |
| Desert Cardiology | Recruiting |
| Rancho Mirage, California, United States | |
| Principal Investigator: Puneet Khanna, MD | |
| United States, Florida | |
| Cardiovascular Research of North Florida | Recruiting |
| Gainesville, Florida, United States | |
| Principal Investigator: Arthur Lee, MD | |
| Mount Sinai Medical Center | Recruiting |
| Miami, Florida, United States | |
| Principal Investigator: Robert Beasley, MD | |
| United States, Illinois | |
| Alexian Brothers Heart and Vascular | Recruiting |
| Elk Grove Village, Illinois, United States | |
| Principal Investigator: Sarah Johnson, MD | |
| United States, Massachusetts | |
| St. Elizabeth's Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02135 | |
| Principal Investigator: Lawrence Garcia, MD | |
| United States, Michigan | |
| St. John's Hospital | Recruiting |
| Detroit, Michigan, United States | |
| Principal Investigator: Tom Davis, MD | |
| Metro Health Hospital | Recruiting |
| Wyoming, Michigan, United States, 49519 | |
| Principal Investigator: Jihad Mustapha, MD | |
| United States, Mississippi | |
| Jackson Heart Clinic | Recruiting |
| Jackson, Mississippi, United States | |
| Principal Investigator: Huey McDaniel, MD | |
| United States, North Carolina | |
| Rex Health | Recruiting |
| Raleigh, North Carolina, United States | |
| Principal Investigator: George Adams | |
| United States, Texas | |
| VA North Texas | Recruiting |
| Dallas, Texas, United States | |
| Principal Investigator: Subhash Banerjee, MD | |
| Cardiovascular Research of Dallas | Recruiting |
| Dallas, Texas, United States | |
| Principal Investigator: Tony Das, MD | |
| United States, Wisconsin | |
| Wheaton Franciscan Healthcare | Recruiting |
| Racine, Wisconsin, United States | |
| Principal Investigator: Thomas Shimshak, MD | |
Sponsors and Collaborators
TriReme Medical, Inc.
Investigators
| 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
No publications provided
| Responsible Party: | TriReme Medical, Inc. |
| ClinicalTrials.gov Identifier: | NCT01589042 History of Changes |
| Other Study ID Numbers: | CLP782 |
| Study First Received: | April 27, 2012 |
| Last Updated: | December 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Peripheral Arterial Disease Peripheral Vascular Diseases Atherosclerosis Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013