CHOCO-CABANA Trial
Primary Purpose
Atherosclerosis
Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Chocolate PTA Balloon
conventional balloon angioplasty
Sponsored by

About this trial
This is an interventional treatment trial for Atherosclerosis
Eligibility Criteria
Inclusion Criteria:
- >18 years of age
- Chronic stenotic or occlusive atherosclerotic disease of the infrapopliteal arteries
- 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
- BTK intervention with lesions between 1 and 25 cm
- Sufficient outflow of the treated artery to the foot (less than 50% stenosis or sufficient collaterals)
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.
- Rutherford 3-5 patients
- Patients who are able to be followed to assess vessel patency according to standard lo-cal hospital care (e.g. DUS, MRA)
- Successfully treated inflow lesions up to TASC B
Exclusion Criteria:
- Acute or sub-acute thrombosis
- In-stent restenosis
- Rutherford 1-2 and 6
- Patient who is not fit for follow-up (including contraindication for MRA)
- Vessel preparation with cutting balloon, lithotripsie, atherectomy
Sites / Locations
- LKH-Univ. Klinikum Graz
- Hanusch-Krankenhaus Kardiovaskuläres Zentrum
- SRH Klinikum Karlsbad-Langensteinbach GmbH
- Herzzentrum Bad Krozingen
- Tepe
- Uniklinik Tübingen
- Elblandklinikum Radebeul Interdisziplinäres Gefäßzentrum Radebeul / Riesa
- Auckland City Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Chocolate PTA balloon
POBA
Arm Description
Intervention with regular baloon
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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%
the re-occlusion rate at 6 months (measured by MRA)
lumen = 0 mm = recocclusion
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
Wound status at 1 and 6 months:
as estimated by the patient (healed, improved, no change, worsened)
target lesion revascularization TLR rate at 1 and 6 months
if an endovascular of surgical therapy of the lesion which was treated is performed
Amputation rate at 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
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)
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
Full Information
NCT ID
NCT04539145
First Posted
August 4, 2020
Last Updated
August 31, 2020
Sponsor
Klinikum Rosenheim
Collaborators
Medtronic, Herz-Zentrums Bad Krozingen, University Hospital Tuebingen, Klinikum Karlsbad-Langensteinbach, Elblandklinikum Radebeul Interdisziplinäres Gefäßzentrum Radebeul / Riesa, LKH-Universitätsklinikum Graz Univ. Klinik für Innere Medizin Klin. Abteilung für Angiologie, Hanusch-Krankenhaus Kardiovaskuläres Zentrum, Auckland City Hospital, SCO:SSiS, coreLab Black Forest GmbH, Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT04539145
Brief Title
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
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 4, 2020 (Actual)
Primary Completion Date
March 27, 2022 (Anticipated)
Study Completion Date
March 27, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Klinikum Rosenheim
Collaborators
Medtronic, Herz-Zentrums Bad Krozingen, University Hospital Tuebingen, Klinikum Karlsbad-Langensteinbach, Elblandklinikum Radebeul Interdisziplinäres Gefäßzentrum Radebeul / Riesa, LKH-Universitätsklinikum Graz Univ. Klinik für Innere Medizin Klin. Abteilung für Angiologie, Hanusch-Krankenhaus Kardiovaskuläres Zentrum, Auckland City Hospital, SCO:SSiS, coreLab Black Forest GmbH, Charite University, Berlin, Germany
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
Masking
Participant
Masking Description
Randomization per envelope
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chocolate PTA balloon
Arm Type
Experimental
Arm Title
POBA
Arm Type
Other
Arm Description
Intervention with regular baloon
Intervention Type
Device
Intervention Name(s)
Chocolate PTA Balloon
Intervention Description
Chocolate PTA Balloon
Intervention Type
Device
Intervention Name(s)
conventional balloon angioplasty
Intervention Description
conventional bal-loon angioplasty
Primary Outcome Measure Information:
Title
Recoil (lumen loss > 30%) 15-30 min after study intervention angiographically documented and analyzed by a core-lab
Description
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 Outcome Measure Information:
Title
the loss of patency greater than 50% in the MRA after six month
Description
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
Title
the re-occlusion rate at 6 months (measured by MRA)
Description
lumen = 0 mm = recocclusion
Time Frame
6 month
Title
Residual stenosis (MLD post compared to RVD, % of RVD) >50% after the invention
Description
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
Title
Wound status at 1 and 6 months:
Description
as estimated by the patient (healed, improved, no change, worsened)
Time Frame
1 and 6 months
Title
target lesion revascularization TLR rate at 1 and 6 months
Description
if an endovascular of surgical therapy of the lesion which was treated is performed
Time Frame
1 and 6 months
Title
Amputation rate at 1 and 6 months
Time Frame
1 and 6 months
Title
Clinical presentation (Rutherford 0, 1, 2, 3, 4, 5 or 6 at 30 days and 6 months
Description
Rutherford 0 = no symptoms, Rutherford 6 = worst symptoms
Time Frame
1 and 6 month
Title
Ancle brachial index (ABI) compared to baseline and post intervention and 6 months
Description
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
Title
DUS vs. MRA at 6 months
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
>18 years of age
Chronic stenotic or occlusive atherosclerotic disease of the infrapopliteal arteries
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
BTK intervention with lesions between 1 and 25 cm
Sufficient outflow of the treated artery to the foot (less than 50% stenosis or sufficient collaterals)
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.
Rutherford 3-5 patients
Patients who are able to be followed to assess vessel patency according to standard lo-cal hospital care (e.g. DUS, MRA)
Successfully treated inflow lesions up to TASC B
Exclusion Criteria:
Acute or sub-acute thrombosis
In-stent restenosis
Rutherford 1-2 and 6
Patient who is not fit for follow-up (including contraindication for MRA)
Vessel preparation with cutting balloon, lithotripsie, atherectomy
Facility Information:
Facility Name
LKH-Univ. Klinikum Graz
City
Graz
Country
Austria
Facility Name
Hanusch-Krankenhaus Kardiovaskuläres Zentrum
City
Wien
ZIP/Postal Code
1140
Country
Austria
Facility Name
SRH Klinikum Karlsbad-Langensteinbach GmbH
City
Karlsbad (Baden)
State/Province
Baden-Wuettenberg
ZIP/Postal Code
76307
Country
Germany
Facility Name
Herzzentrum Bad Krozingen
City
Bad Krozingen
State/Province
BW
ZIP/Postal Code
73000
Country
Germany
Facility Name
Tepe
City
Rosenheim
State/Province
BW
ZIP/Postal Code
83022
Country
Germany
Facility Name
Uniklinik Tübingen
City
Tuebingen
State/Province
BW
ZIP/Postal Code
73022
Country
Germany
Facility Name
Elblandklinikum Radebeul Interdisziplinäres Gefäßzentrum Radebeul / Riesa
City
Radebeul
ZIP/Postal Code
01445
Country
Germany
Facility Name
Auckland City Hospital
City
Grafton
ZIP/Postal Code
1023
Country
New Zealand
12. IPD Sharing Statement
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CHOCO-CABANA Trial
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