Chocolate Balloon Angioplasty Registry (Chocolate BAR)

TriReme Medical

Status: Completed

Conditions: Peripheral Arterial Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT01589042

CLP782

Details and patient eligibility

About

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.

Enrollment: 490 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

490 participants in 2 patient groups

Above the Knee

Description:

Patients treated with the Chocolate balloon for a lesion located above the knee

Below the Knee

Description:

Patients treated with the Chocolate balloon for a lesion located below the knee