CHOCO-CABANA Trial

August 31, 2020 updated by: Prof. Dr. med. Gunnar Tepe, Klinikum Rosenheim

Chocolate PTA Balloon Compared to Conventional Balloon Angioplasty for Sustained Lumen Gain in Below the Knee Arteries - CHOCO-CABANA Trial-

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • LKH-Univ. Klinikum Graz
      • Wien, Austria, 1140
        • Hanusch-Krankenhaus Kardiovaskuläres Zentrum
  • Germany
      • Radebeul, Germany, 01445
        • Elblandklinikum Radebeul Interdisziplinäres Gefäßzentrum Radebeul / Riesa
    • BW
      • Bad Krozingen, BW, Germany, 73000
        • Herzzentrum Bad Krozingen
      • Rosenheim, BW, Germany, 83022
        • Tepe
      • Tuebingen, BW, Germany, 73022
        • Uniklinik Tübingen
    • Baden-Wuettenberg
      • Karlsbad (Baden), Baden-Wuettenberg, Germany, 76307
        • SRH Klinikum Karlsbad-Langensteinbach GmbH
  • New Zealand
      • Grafton, New Zealand, 1023
        • Auckland City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Chocolate PTA balloon
Device: Chocolate PTA Balloon
Chocolate PTA Balloon
Other: POBA
Intervention with regular baloon
Device: conventional balloon angioplasty
conventional bal-loon angioplasty

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recoil (lumen loss > 30%) 15-30 min after study intervention angiographically documented and analyzed by a core-lab
Time Frame: 15-30 min after study intervention
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
15-30 min after study intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
the loss of patency greater than 50% in the MRA after six month
Time Frame: 6 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%
6 month
the re-occlusion rate at 6 months (measured by MRA)
Time Frame: 6 month
lumen = 0 mm = recocclusion
6 month
Residual stenosis (MLD post compared to RVD, % of RVD) >50% after the invention
Time Frame: immedetely after the intervention
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
immedetely after the intervention
Wound status at 1 and 6 months:
Time Frame: 1 and 6 months
as estimated by the patient (healed, improved, no change, worsened)
1 and 6 months
target lesion revascularization TLR rate at 1 and 6 months
Time Frame: 1 and 6 months
if an endovascular of surgical therapy of the lesion which was treated is performed
1 and 6 months
Amputation rate at 1 and 6 months
Time Frame: 1 and 6 months
1 and 6 months
Clinical presentation (Rutherford 0, 1, 2, 3, 4, 5 or 6 at 30 days and 6 months
Time Frame: 1 and 6 month
Rutherford 0 = no symptoms, Rutherford 6 = worst symptoms
1 and 6 month
Ancle brachial index (ABI) compared to baseline and post intervention and 6 months
Time Frame: directly after the intervention and 6 month
Blood pressure in the arm divided by blood pressure in the distal leg (normal value: 0.8-1.2)
directly after the intervention and 6 month
DUS vs. MRA at 6 months
Time Frame: 6 month
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
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Klinikum Rosenheim

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Charite University, Berlin, Germany
Medtronic
University Hospital Tuebingen
Herz-Zentrums Bad Krozingen
Auckland City Hospital
coreLab Black Forest GmbH
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
SCO:SSiS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 4, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 27, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 27, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RO-012020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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