Chocolate Balloon Angioplasty Registry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01589042

Acronym

Chocolate BAR

Enrollment

490

Registered

2012-05-01

Start date

2012-05-31

Completion date

2015-12-31

Last updated

2018-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results