Trial record 1 of 1 for:    Chocolate Bar Registry
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Chocolate Balloon Angioplasty Registry (Chocolate BAR)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
TriReme Medical, LLC
ClinicalTrials.gov Identifier:
NCT01589042
First received: April 27, 2012
Last updated: May 11, 2015
Last verified: December 2014
  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, LLC:

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
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01589042

Locations
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
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, LLC
ClinicalTrials.gov Identifier: NCT01589042     History of Changes
Other Study ID Numbers: CLP782
Study First Received: April 27, 2012
Last Updated: May 11, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 21, 2015