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CHOCO-CABANA Trial

Primary Purpose

Atherosclerosis

Status

Unknown status

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Chocolate PTA Balloon

conventional balloon angioplasty

About this trial

This is an interventional treatment trial for Atherosclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

ZIP/Postal Code

73000

Country

Germany

Facility Name

Tepe

City

Rosenheim

State/Province

ZIP/Postal Code

83022

Country

Germany

Facility Name

Uniklinik Tübingen

City

Tuebingen

State/Province

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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