CHOCO-CABANA Trial

Klinikum Rosenheim

Status and phase: Unknown; Phase 4

Conditions: Atherosclerosis

Treatments: Device: conventional balloon angioplasty; Device: Chocolate PTA Balloon

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04539145

RO-012020

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. >18 years of age

2. Chronic stenotic or occlusive atherosclerotic disease of the infrapopliteal arteries

3. Patients with clinical conditions requiring assessment of vessel patency of treated BTK lesion 6 months post procedure as part of clinical standard of care to prevent amputa-tions as consequence of non-detected re-stenosis

4. BTK intervention with lesions between 1 and 25 cm

5. Sufficient outflow of the treated artery to the foot (less than 50% stenosis or sufficient collaterals)

6. All BTK lesions either to be treated with conventional PTA or with the Chocolate PTA balloon (if inclusion criteria 4 and 5 apply)*

   * The longest lesion will be taken as primary lesion. All other lesions will be also analyzed within the study protocol but separately evaluated. If a secondary lesion does not fulfill the inclusion criteria 4 and 5, the lesion can be treated upon the decision of the operator and will not be analyzed within the study protocol.

7. Rutherford 3-5 patients

8. Patients who are able to be followed to assess vessel patency according to standard lo-cal hospital care (e.g. DUS, MRA)

9. Successfully treated inflow lesions up to TASC B

Exclusion criteria

1. Acute or sub-acute thrombosis
2. In-stent restenosis
3. Rutherford 1-2 and 6
4. Patient who is not fit for follow-up (including contraindication for MRA)
5. Vessel preparation with cutting balloon, lithotripsie, atherectomy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Chocolate PTA balloon

Experimental group

Treatment:

Device: Chocolate PTA Balloon

POBA

Other group

Description:

Intervention with regular baloon

Treatment:

Device: conventional balloon angioplasty