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AtherosclerosisPhase 4NCT04539145

CHOCO-CABANA Trial

A Phase 4 study testing Chocolate PTA Balloon and conventional balloon angioplasty in people with Atherosclerosis, run by Klinikum Rosenheim at 8 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atherosclerosis
What is being tested?
Chocolate PTA Balloon and conventional balloon angioplasty
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
8 sitesin 3 countries
Study dates
4 Aug 2020to 27 Mar 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • >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)*
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

8 sites in 3 countries.

8 sites in 3 countries

Germany5 sites

  • Herzzentrum Bad Krozingen

    Bad Krozingen, Baden-Wurttemberg, 73000

  • SRH Klinikum Karlsbad-Langensteinbach GmbH

    Karlsbad (Baden), Baden-Wuettenberg, 76307

  • Elblandklinikum Radebeul Interdisziplinäres Gefäßzentrum Radebeul / Riesa

    Radebeul, 01445

  • Tepe

    Rosenheim, Baden-Wurttemberg, 83022

  • Uniklinik Tübingen

    Tübingen, Baden-Wurttemberg, 73022

Other trials in Germany

Austria2 sites

  • LKH-Univ. Klinikum Graz

    Graz

  • Hanusch-Krankenhaus Kardiovaskuläres Zentrum

    Vienna, 1140

Other trials in Austria

New Zealand1 site

  • Auckland City Hospital

    Grafton, 1023

Other trials in New Zealand

About this study

Official title: 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.

Conditions
Atherosclerosis
Being tested
Chocolate PTA Balloon, conventional balloon angioplasty
Medical subject headings
Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chocolate PTA BalloonDevice

    Chocolate PTA Balloon

  • conventional balloon angioplastyDevice

    conventional bal-loon angioplasty

Study groups in NCT04539145
Study groupRoleWhat they receive
Chocolate PTA balloonExperimentalNot described
Receives: Device: Chocolate PTA Balloon
POBAOtherIntervention with regular baloon
Receives: Device: conventional balloon angioplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 15-30 min after study intervention

Secondary outcomes (9)

  1. 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%

    Measured: 6 month

  2. the re-occlusion rate at 6 months (measured by MRA)

    lumen = 0 mm = recocclusion

    Measured: 6 month

  3. 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

    Measured: immedetely after the intervention

  4. Wound status at 1 and 6 months:

    as estimated by the patient (healed, improved, no change, worsened)

    Measured: 1 and 6 months

  5. target lesion revascularization TLR rate at 1 and 6 months

    if an endovascular of surgical therapy of the lesion which was treated is performed

    Measured: 1 and 6 months

  6. Amputation rate at 1 and 6 months

    Measured: 1 and 6 months

  7. 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

    Measured: 1 and 6 month

  8. 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)

    Measured: directly after the intervention and 6 month

  9. 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

    Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2020
  2. Study start4 Aug 2020
  3. Primary completion27 Mar 2022 (estimated)
  4. Study completion27 Mar 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Participant
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04539145
Sponsor's protocol ID
RO-012020
Status last verified
Aug 2020
First submitted
4 Aug 2020
Last updated
4 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Chocolate PTA Balloon and conventional balloon angioplasty in people with Atherosclerosis, run by Klinikum Rosenheim at 8 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Germany, Austria, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04539145.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.

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