CHOCO-CABANA Trial

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: Unknown
• Conditions: Atherosclerosis
• Intervention / Treatment: Device: Chocolate PTA Balloon; Device: conventional balloon angioplasty

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%	6 month
the re-occlusion rate at 6 months (measured by MRA)	lumen = 0 mm = recocclusion	6 month
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	immedetely after the intervention
Wound status at 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	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		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	1 and 6 month
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)	directly after the intervention and 6 month
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	6 month

Collaborators and Investigators

• Sponsor: Klinikum Rosenheim
• Collaborators: 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

Study Major Dates

• Study Start (Actual): August 4, 2020
• Primary Completion (Anticipated): March 27, 2022
• Study Completion (Anticipated): March 27, 2022

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (Actual): September 4, 2020

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID 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