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Chocolate Balloon Angioplasty Registry (Chocolate BAR)

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ClinicalTrials.gov Identifier: NCT01589042
Recruitment Status : Completed
First Posted : May 1, 2012
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
TriReme Medical, LLC

Study Description
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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.

Condition or disease
Peripheral Arterial Disease

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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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
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
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Information from the National Library of Medicine

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


Locations
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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
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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
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Responsible Party: TriReme Medical, LLC
ClinicalTrials.gov Identifier: NCT01589042     History of Changes
Other Study ID Numbers: CLP782
First Posted: May 1, 2012    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases