Chocolate Balloon Angioplasty Registry

Completed

Conditions studied: Peripheral Arterial Disease

In brief

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.

Key facts

Study ID

NCT01589042

Run by

TriReme Medical, LLC

People needed

490

Starts

2012-05-01

Expected to finish

2015-12-01

Last updated by the study team

2018-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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