CHOCO-CABANA Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-04

Study Completion Date

2022-03-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

120 patients (60 per group) Special balloon (chocolate balloon with a special nitiol cage around the balloon - not drug coated) versus standard uncoated balloon

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Randomization per envelope

Study Groups

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Chocolate PTA balloon

Group Type EXPERIMENTAL

Chocolate PTA Balloon

Intervention Type DEVICE

Chocolate PTA Balloon

POBA

Intervention with regular baloon

Group Type OTHER

conventional balloon angioplasty

Intervention Type DEVICE

conventional bal-loon angioplasty

Interventions

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Chocolate PTA Balloon

Intervention Type DEVICE

conventional balloon angioplasty

conventional bal-loon angioplasty

Intervention Type DEVICE

Eligibility Criteria

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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)

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No