Chocolate Balloon Angioplasty Registry

Completed

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT01589042
• Lead Sponsor: TriReme Medical, LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-27
• Study First Submitted QC: 2012-04-30
• Study Start: 2012-05
• Study First Posted: 2012-05-01
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-07
• Last Update Posted: 2018-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 490

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Achievement of Optimal PTA	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

Trial Locations

Locations (13)

Rex Health; 🇺🇸 Raleigh, North Carolina, United States

VA North Texas; 🇺🇸 Dallas, Texas, United States

Desert Cardiology; 🇺🇸 Rancho Mirage, California, United States

St. Elizabeth's Medical Center; 🇺🇸 Boston, Massachusetts, United States

Cardiovascular Research of Dallas; 🇺🇸 Dallas, Texas, United States

St. John's Hospital; 🇺🇸 Detroit, Michigan, United States

Alexian Brothers Heart and Vascular; 🇺🇸 Elk Grove Village, Illinois, United States

Arizona Heart Institute; 🇺🇸 Phoenix, Arizona, United States

Jackson Heart Clinic; 🇺🇸 Jackson, Mississippi, United States

Cardiovascular Research of North Florida; 🇺🇸 Gainesville, Florida, United States

Mount Sinai Medical Center; 🇺🇸 Miami, Florida, United States

Wheaton Franciscan Healthcare; 🇺🇸 Racine, Wisconsin, United States

Metro Health Hospital; 🇺🇸 Wyoming, Michigan, United States