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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04539145




Registration number
NCT04539145
Ethics application status
Date submitted
4/08/2020
Date registered
4/09/2020
Date last updated
4/09/2020

Titles & IDs
Public title
CHOCO-CABANA Trial
Scientific title
Chocolate PTA Balloon Compared to Conventional Balloon Angioplasty for Sustained Lumen Gain in Below the Knee Arteries - CHOCO-CABANA Trial-
Secondary ID [1] 0 0
RO-012020
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Chocolate PTA Balloon
Treatment: Devices - conventional balloon angioplasty

Experimental: Chocolate PTA balloon -

Other: POBA - Intervention with regular baloon


Treatment: Devices: Chocolate PTA Balloon
Chocolate PTA Balloon

Treatment: Devices: conventional balloon angioplasty
conventional bal-loon angioplasty
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recoil (lumen loss > 30%) 15-30 min after study intervention angiographically documented and analyzed by a core-lab
Timepoint [1] 0 0
15-30 min after study intervention
Secondary outcome [1] 0 0
the loss of patency greater than 50% in the MRA after six month
Timepoint [1] 0 0
6 month
Secondary outcome [2] 0 0
the re-occlusion rate at 6 months (measured by MRA)
Timepoint [2] 0 0
6 month
Secondary outcome [3] 0 0
Residual stenosis (MLD post compared to RVD, % of RVD) >50% after the invention
Timepoint [3] 0 0
immedetely after the intervention
Secondary outcome [4] 0 0
Wound status at 1 and 6 months:
Timepoint [4] 0 0
1 and 6 months
Secondary outcome [5] 0 0
target lesion revascularization TLR rate at 1 and 6 months
Timepoint [5] 0 0
1 and 6 months
Secondary outcome [6] 0 0
Amputation rate at 1 and 6 months
Timepoint [6] 0 0
1 and 6 months
Secondary outcome [7] 0 0
Clinical presentation (Rutherford 0, 1, 2, 3, 4, 5 or 6 at 30 days and 6 months
Timepoint [7] 0 0
1 and 6 month
Secondary outcome [8] 0 0
Ancle brachial index (ABI) compared to baseline and post intervention and 6 months
Timepoint [8] 0 0
directly after the intervention and 6 month
Secondary outcome [9] 0 0
DUS vs. MRA at 6 months
Timepoint [9] 0 0
6 month

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/03/2022
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Wien
Country [3] 0 0
Germany
State/province [3] 0 0
Baden-Wuettenberg
Country [4] 0 0
Germany
State/province [4] 0 0
BW
Country [5] 0 0
Germany
State/province [5] 0 0
Radebeul
Country [6] 0 0
New Zealand
State/province [6] 0 0
Grafton

Funding & Sponsors
Primary sponsor type
Other
Name
Klinikum Rosenheim
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Medtronic
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Herz-Zentrums Bad Krozingen
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University Hospital Tuebingen
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Klinikum Karlsbad-Langensteinbach
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Elblandklinikum Radebeul Interdisziplinäres Gefäßzentrum Radebeul / Riesa
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
LKH-Universitätsklinikum Graz Univ. Klinik für Innere Medizin Klin. Abteilung für Angiologie
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Hanusch-Krankenhaus Kardiovaskuläres Zentrum
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Auckland City Hospital
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
SCO:SSiS
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
coreLab Black Forest GmbH
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
Charite University, Berlin, Germany
Address [11] 0 0
Country [11] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04539145
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04539145