Chocolate Balloon Angioplasty Registry (Chocolate BAR)

This study is currently recruiting participants.
Verified December 2012 by TriReme Medical, Inc.
Sponsor:
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
  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:

  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
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 April 16, 2014