NCT04539145

CHOCO-CABANA Trial

Chocolate PTA Balloon Compared to Conventional Balloon Angioplasty for Sustained Lumen Gain in Below the Knee Arteries - CHOCO-CABANA Trial-

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Klinikum Rosenheim · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will be performed 120 patients at about 6 to 8 study centers. Only patients with clinical conditions requiring assessment of patency of the treated BTK lesions at 6 months post procedure by MRA as part of standard care to prevent amputations as consequence of non-detected re-stenosis/occlusions will be included in the study. The sequence in which the individual patients will be treated will be randomized with the Chocolate PTA balloon and the uncoated conventional PTA balloon at each center. 60 patients will be randomized to uncoated conventional PTA balloon treatment and 60 patients to treatment with the Chocolate PTA balloon. All lesions in each patient (lesions that fulfill the inclusion/exclusion criteria) should be treated as the patient is randomized. In patients with long lesions more than one balloon may be used. Overlapping of balloons (at least 10mm) is mandatory to avoid untreated gaps between sequential treatments. Follow up will be performed at 1 and 6 months.

Conditions

• Atherosclerosis

Interventions

Type	Name	Description
DEVICE	Chocolate PTA Balloon	Chocolate PTA Balloon
DEVICE	conventional balloon angioplasty	conventional bal-loon angioplasty

Timeline

• Start date: 2020-08-04
• Primary completion: 2022-03-27
• Completion: 2022-03-27
• First posted: 2020-09-04
• Last updated: 2020-09-04

Locations

8 sites across 3 countries: Austria, Germany, New Zealand