CHOCO-CABANA Trial

NCT04539145 | Unknown Phase 4

• 1 other identifier: RO-012020
• Study Type: interventional
• Target: 120
• Locations: 3 countries
• Sites: 8

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.

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (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

  15-30 min after study intervention

Secondary Outcomes (9)

• the loss of patency greater than 50% in the MRA after six month

  6 month

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

  6 month

• Residual stenosis (MLD post compared to RVD, % of RVD) >50% after the invention

  immedetely after the intervention

• Wound status at 1 and 6 months:

  1 and 6 months

• target lesion revascularization TLR rate at 1 and 6 months

  1 and 6 months

Study Arms (2)

Chocolate PTA balloon

EXPERIMENTAL

Device: Chocolate PTA Balloon

POBA

OTHER

Intervention with regular baloon

Device: conventional balloon angioplasty

Interventions

Chocolate PTA Balloon DEVICE

Chocolate PTA Balloon

Chocolate PTA balloon

conventional balloon angioplasty DEVICE

conventional bal-loon angioplasty

POBA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Klinikum Rosenheim: lead
• Medtronic: collaborator
• Herz-Zentrums Bad Krozingen: collaborator
• University Hospital Tuebingen: collaborator
• Klinikum Karlsbad-Langensteinbach: collaborator
• Elblandklinikum Radebeul Interdisziplinäres Gefäßzentrum Radebeul / Riesa: collaborator
• LKH-Universitätsklinikum Graz Univ. Klinik für Innere Medizin Klin. Abteilung für Angiologie: collaborator
• Hanusch-Krankenhaus Kardiovaskuläres Zentrum: collaborator
• Auckland City Hospital: collaborator
• SCO:SSiS: collaborator
• coreLab Black Forest GmbH: collaborator
• Charite University, Berlin, Germany: collaborator

Study Sites (8)

LKH-Univ. Klinikum Graz

Graz, Austria

Location

Hanusch-Krankenhaus Kardiovaskuläres Zentrum

Vienna, 1140, Austria

Location

SRH Klinikum Karlsbad-Langensteinbach GmbH

Karlsbad (Baden), Baden-Wuettenberg, 76307, Germany

Location

Herzzentrum Bad Krozingen

Bad Krozingen, Baden-Wurttemberg, 73000, Germany

Location

Tepe

Rosenheim, Baden-Wurttemberg, 83022, Germany

Location

Uniklinik Tübingen

Tübingen, Baden-Wurttemberg, 73022, Germany

Location

Elblandklinikum Radebeul Interdisziplinäres Gefäßzentrum Radebeul / Riesa

Radebeul, 01445, Germany

Location

Auckland City Hospital

Grafton, 1023, New Zealand

Location

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomization per envelope
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician of the Radiology Department

Model Details: 120 patients (60 per group) Special balloon (chocolate balloon with a special nitiol cage around the balloon - not drug coated) versus standard uncoated balloon

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: September 4, 2020
• Study Start: August 4, 2020
• Primary Completion: March 27, 2022
• Study Completion: March 27, 2022
• Last Updated: September 4, 2020

Record last verified: 2020-08

Locations

DE (5); NZ (1); AU (2)