CHOCO-CABANA Trial

Klinikum Rosenheim120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Atherosclerosis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

LKH-Univ. Klinikum Graz

Graz, Austria

Hanusch-Krankenhaus Kardiovaskuläres Zentrum

Vienna, Austria

SRH Klinikum Karlsbad-Langensteinbach GmbH

Karlsbad (Baden), Baden-Wuettenberg, Germany

Herzzentrum Bad Krozingen

Bad Krozingen, Baden-Wurttemberg, Germany

Tepe

Rosenheim, Baden-Wurttemberg, Germany

Uniklinik Tübingen

Tübingen, Baden-Wurttemberg, Germany

Elblandklinikum Radebeul Interdisziplinäres Gefäßzentrum Radebeul / Riesa

Radebeul, Germany

Auckland City Hospital

Grafton, New Zealand

Outcomes

Primary Outcomes

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

Time frame: 15-30 min after study intervention

Secondary Outcomes

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%

Time frame: 6 month

the re-occlusion rate at 6 months (measured by MRA)

lumen = 0 mm = recocclusion

Time frame: 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

Time frame: immedetely after the intervention

Wound status at 1 and 6 months:

as estimated by the patient (healed, improved, no change, worsened)

Time frame: 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

Time frame: 1 and 6 months

Amputation rate at 1 and 6 months

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 6 month