Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
490 participants
OBSERVATIONAL
2012-05-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Above the Knee
Patients treated with the Chocolate balloon for a lesion located above the knee
No interventions assigned to this group
Below the Knee
Patients treated with the Chocolate balloon for a lesion located below the knee
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
2. Life expectancy \<12 months
3. Patient is enrolled in another clinical study that may impact the results of this registry
18 Years
ALL
No
Sponsors
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TriReme Medical, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Jihad Mustapha, MD
Role: PRINCIPAL_INVESTIGATOR
Metro Health Hospital
Lawrence Garcia, MD
Role: PRINCIPAL_INVESTIGATOR
St Elizabeth's Med Center / Tufts Univ School of Medicine
Locations
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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, United States
St. John's Hospital
Detroit, Michigan, United States
Metro Health Hospital
Wyoming, Michigan, 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
Countries
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Other Identifiers
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CLP782
Identifier Type: -
Identifier Source: org_study_id
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