CHOCO-CABANA Trial

Study Overview
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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.

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

Conditions
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Atherosclerosis

Intervention / Treatment
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* Device: Chocolate PTA Balloon
* Device: conventional balloon angioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years of age Chronic stenotic or occlusive atherosclerotic disease of the infrapopliteal arteries 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 BTK intervention with lesions between 1 and 25 cm Sufficient outflow of the treated artery to the foot (less than 50% stenosis or sufficient collaterals) 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. Rutherford 3-5 patients Patients who are able to be followed to assess vessel patency according to standard lo-cal hospital care (e.g. DUS, MRA) Successfully treated inflow lesions up to TASC B Exclusion Criteria: Acute or sub-acute thrombosis In-stent restenosis Rutherford 1-2 and 6 Patient who is not fit for follow-up (including contraindication for MRA) Vessel preparation with cutting balloon, lithotripsie, atherectomy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 120 patients (60 per group) Special balloon (chocolate balloon with a special nitiol cage around the balloon - not drug coated) versus standard uncoated balloon
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chocolate PTA balloon<br> | Device: Chocolate PTA Balloon<br>* Chocolate PTA Balloon<br>|
| Other: POBA<br>Intervention with regular baloon | Device: conventional balloon angioplasty<br>* conventional bal-loon angioplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recoil (lumen loss > 30%) 15-30 min after study intervention angiographically documented and analyzed by a core-lab | The minimal lumen of the artery in the area of Intervention in mm will be compared directly after the Intervention and at 15-30 minuntes | 15-30 min after study intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the loss of patency greater than 50% in the MRA after six month | the lumen of the artery directly after the Intervention, 15 min after the Intervention and at 6 months will be compared (in mm). It is a secondary outcome if the loss is greater than 50% | 6 month | 
| the re-occlusion rate at 6 months (measured by MRA) | lumen = 0 mm = recocclusion | 6 month | 
| Residual stenosis (MLD post compared to RVD, % of RVD) >50% after the invention | interventional success: lumen of the artery directly after the Intervention (compared to the healthy vessel next to the lesion - in mm) - RVD = reference vessel Diameter, MLD = Minimum lumen diameter | immedetely after the intervention | 
| Wound status at 1 and 6 months: | as estimated by the patient (healed, improved, no change, worsened) | 1 and 6 months | 
| target lesion revascularization TLR rate at 1 and 6 months | if an endovascular of surgical therapy of the lesion which was treated is performed | 1 and 6 months | 
| Amputation rate at 1 and 6 months |  | 1 and 6 months | 
| Clinical presentation (Rutherford 0, 1, 2, 3, 4, 5 or 6 at 30 days and 6 months | Rutherford 0 = no symptoms, Rutherford 6 = worst symptoms | 1 and 6 month | 
| Ancle brachial index (ABI) compared to baseline and post intervention and 6 months | Blood pressure in the arm divided by blood pressure in the distal leg (normal value: 0.8-1.2) | directly after the intervention and 6 month | 
| DUS vs. MRA at 6 months | both by DUS and MRA % Stenosis of the index lesion will be calculated. They will be compared in order to see if DUS has the same value as MRA | 6 month |