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Chocolate Balloon Angioplasty Registry (Chocolate BAR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TriReme Medical, LLC
ClinicalTrials.gov Identifier:
NCT01589042
First received: April 27, 2012
Last updated: June 1, 2016
Last verified: June 2016

April 27, 2012
June 1, 2016
May 2012
December 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01589042 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
Chocolate Balloon Angioplasty Registry
Chocolate Balloon Angioplasty Registry
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample
Patients with Peripheral Arterial Disease appropriate for treatment with balloon angioplasty
Peripheral Arterial Disease
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
490
Not Provided
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01589042
CLP782
No
Not Provided
Not Provided
TriReme Medical, LLC
TriReme Medical, LLC
Not Provided
Principal Investigator: Jihad Mustapha, MD Metro Health Hospital
Principal Investigator: Lawrence Garcia, MD St Elizabeth's Med Center / Tufts Univ School of Medicine
TriReme Medical, LLC
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP