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OpenTrials
Completed

NCT Number: NCT01589042

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.

Completed

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Arizona Heart Institute, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >18 years of age
  • Lesion successfully crossed with a guide-wire
  • Reference Vessel Diameter (RVD) within the treatment range of the Chocolate PTA Catheter used at the target lesion appropriate for 1:1 dilatation
  • Patient has given consent for their information to be submitted to this registry

Exclusion criteria

  • Lesion required stenting as the primary treatment approach
  • Life expectancy <12 months
  • Patient is enrolled in another clinical study that may impact the results of this registry

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

TriReme Medical, LLC

Industry

Registry information

Acronym: Chocolate BAR

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 1, 2012
Registry last updated
Sep 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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