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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Government body
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04539145