CHOCO-CABANA Trial

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

DEVICE

Chocolate PTA Balloon

Chocolate PTA Balloon

DEVICE

conventional balloon angioplasty

conventional bal-loon angioplasty

Sponsors & Collaborators

• Medtronic

  collaborator INDUSTRY

• Herz-Zentrums Bad Krozingen

  collaborator OTHER

• University Hospital Tuebingen

  collaborator OTHER

• Klinikum Karlsbad-Langensteinbach

  collaborator OTHER

• Elblandklinikum Radebeul Interdisziplinäres Gefäßzentrum Radebeul / Riesa

  collaborator UNKNOWN

• LKH-Universitätsklinikum Graz Univ. Klinik für Innere Medizin Klin. Abteilung für Angiologie

  collaborator UNKNOWN

• Hanusch-Krankenhaus Kardiovaskuläres Zentrum

  collaborator UNKNOWN

• Auckland City Hospital

  collaborator OTHER_GOV

• SCO:SSiS

  collaborator UNKNOWN

• coreLab Black Forest GmbH

  collaborator UNKNOWN

• Charite University, Berlin, Germany

  collaborator OTHER

• Klinikum Rosenheim

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-04

Primary Completion

2022-03-27

Completion

2022-03-27

Countries

• Austria
• Germany
• New Zealand

Study Locations