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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
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Scientific title
Chocolate PTA Balloon Compared to Conventional Balloon Angioplasty for Sustained Lumen Gain in Below the Knee Arteries - CHOCO-CABANA Trial-
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Secondary ID [1]
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RO-012020
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atherosclerosis
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Recoil (lumen loss > 30%) 15-30 min after study intervention angiographically documented and analyzed by a core-lab
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Assessment method [1]
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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
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Timepoint [1]
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15-30 min after study intervention
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Secondary outcome [1]
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the loss of patency greater than 50% in the MRA after six month
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Assessment method [1]
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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%
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Timepoint [1]
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6 month
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Secondary outcome [2]
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the re-occlusion rate at 6 months (measured by MRA)
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Assessment method [2]
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lumen = 0 mm = recocclusion
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Timepoint [2]
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6 month
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Secondary outcome [3]
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Residual stenosis (MLD post compared to RVD, % of RVD) >50% after the invention
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Assessment method [3]
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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
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Timepoint [3]
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immedetely after the intervention
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Secondary outcome [4]
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Wound status at 1 and 6 months:
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Assessment method [4]
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as estimated by the patient (healed, improved, no change, worsened)
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Timepoint [4]
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1 and 6 months
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Secondary outcome [5]
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target lesion revascularization TLR rate at 1 and 6 months
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Assessment method [5]
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if an endovascular of surgical therapy of the lesion which was treated is performed
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Timepoint [5]
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1 and 6 months
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Secondary outcome [6]
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Amputation rate at 1 and 6 months
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Assessment method [6]
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Timepoint [6]
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1 and 6 months
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Secondary outcome [7]
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Clinical presentation (Rutherford 0, 1, 2, 3, 4, 5 or 6 at 30 days and 6 months
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Assessment method [7]
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Rutherford 0 = no symptoms, Rutherford 6 = worst symptoms
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Timepoint [7]
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1 and 6 month
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Secondary outcome [8]
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Ancle brachial index (ABI) compared to baseline and post intervention and 6 months
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Assessment method [8]
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Blood pressure in the arm divided by blood pressure in the distal leg (normal value: 0.8-1.2)
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Timepoint [8]
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directly after the intervention and 6 month
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Secondary outcome [9]
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DUS vs. MRA at 6 months
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Assessment method [9]
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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
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Timepoint [9]
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6 month
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/08/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
27/03/2022
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Actual
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Sample size
Target
120
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Graz
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Country [2]
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Austria
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State/province [2]
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Wien
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Germany
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State/province [3]
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Baden-Wuettenberg
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Germany
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State/province [4]
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BW
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Germany
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State/province [5]
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Radebeul
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Country [6]
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New Zealand
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State/province [6]
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Grafton
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Funding & Sponsors
Primary sponsor type
Other
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Name
Klinikum Rosenheim
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Medtronic
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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Herz-Zentrums Bad Krozingen
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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University Hospital Tuebingen
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Address [3]
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Other collaborator category [4]
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Other
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Name [4]
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Klinikum Karlsbad-Langensteinbach
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Address [4]
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Other collaborator category [5]
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Other
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Name [5]
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Elblandklinikum Radebeul Interdisziplinäres Gefäßzentrum Radebeul / Riesa
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Address [5]
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Other collaborator category [6]
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Other
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Name [6]
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LKH-Universitätsklinikum Graz Univ. Klinik für Innere Medizin Klin. Abteilung für Angiologie
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Address [6]
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Other collaborator category [7]
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Other
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Name [7]
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Hanusch-Krankenhaus Kardiovaskuläres Zentrum
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Address [7]
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Other collaborator category [8]
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Government body
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Name [8]
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Auckland City Hospital
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Address [8]
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Other collaborator category [9]
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Other
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Name [9]
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SCO:SSiS
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Address [9]
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Other collaborator category [10]
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Other
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Name [10]
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coreLab Black Forest GmbH
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Address [10]
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Other collaborator category [11]
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Other
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Name [11]
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Charite University, Berlin, Germany
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Address [11]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT04539145
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Fax
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Email
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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
Download to PDF