Clinical trial NCT04539145: CHOCO-CABANA Trial
Official title: Chocolate PTA Balloon Compared to Conventional Balloon Angioplasty for Sustained Lumen Gain in Below the Knee Arteries - CHOCO-CABANA Trial-
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atherosclerosis
Lead sponsor: Klinikum Rosenheim
Sponsor class: OTHER
Collaborators: name: Medtronic
name: Herz-Zentrums Bad Krozingen
name: University Hospital Tuebingen
name: Klinikum Karlsbad-Langensteinbach
name: Elblandklinikum Radebeul Interdisziplinäres Gefäßzentrum Radebeul / Riesa
name: LKH-Universitätsklinikum Graz Univ. Klinik für Innere Medizin Klin. Abteilung für Angiologie
name: Hanusch-Krankenhaus Kardiovaskuläres Zentrum
name: Auckland City Hospital
name: SCO:SSiS
name: coreLab Black Forest GmbH
name: Charite University, Berlin, Germany
First posted: 2020-09-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Recoil (lumen loss > 30%) 15-30 min after study intervention angiographically documented and analyzed by a core-lab
timeFrame: 15-30 min after study intervention
Secondary outcomes:
measure: the loss of patency greater than 50% in the MRA after six month
timeFrame: 6 month
measure: the re-occlusion rate at 6 months (measured by MRA)
timeFrame: 6 month
measure: Residual stenosis (MLD post compared to RVD, % of RVD) >50% after the invention
timeFrame: immedetely after the intervention
measure: Wound status at 1 and 6 months:
timeFrame: 1 and 6 months
measure: target lesion revascularization TLR rate at 1 and 6 months
timeFrame: 1 and 6 months
measure: Amputation rate at 1 and 6 months
timeFrame: 1 and 6 months
measure: Clinical presentation (Rutherford 0, 1, 2, 3, 4, 5 or 6 at 30 days and 6 months
timeFrame: 1 and 6 month
measure: Ancle brachial index (ABI) compared to baseline and post intervention and 6 months
timeFrame: directly after the intervention and 6 month
measure: DUS vs. MRA at 6 months
timeFrame: 6 month
Other outcomes:
Locations:
city: Graz
country: Austria
facility: LKH-Univ. Klinikum Graz
city: Wien
country: Austria
facility: Hanusch-Krankenhaus Kardiovaskuläres Zentrum
city: Karlsbad (Baden)
country: Germany
facility: SRH Klinikum Karlsbad-Langensteinbach GmbH
state: Baden-Wuettenberg
city: Bad Krozingen
country: Germany
facility: Herzzentrum Bad Krozingen
state: BW
city: Rosenheim
country: Germany
facility: Tepe
state: BW
city: Tuebingen
country: Germany
facility: Uniklinik Tübingen
state: BW
city: Radebeul
country: Germany
facility: Elblandklinikum Radebeul Interdisziplinäres Gefäßzentrum Radebeul / Riesa
city: Grafton
country: New Zealand
facility: Auckland City Hospital
Study officials:
References: