Chocolate Balloon Angioplasty Registry

TriReme Medical, LLC490 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

490

Conditions

Peripheral Arterial Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

Arizona Heart Institute

Phoenix, Arizona, United States

Desert Cardiology

Rancho Mirage, California, United States

Cardiovascular Research of North Florida

Gainesville, Florida, United States

Outcomes

Primary Outcomes

Achievement of Optimal PTA

Percentage of PTA cases in which \<30% diameter stenosis without a flow limiting dissection is achieved without the need for bail-out stenting

Time frame: average of 2 hours

Data from ClinicalTrials.gov

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