CHOCO-CABANA Trial

Phase 4

• Conditions: Atherosclerosis
• Interventions: Device: conventional balloon angioplasty; Device: Chocolate PTA Balloon

• Registration Number: NCT04539145
• Lead Sponsor: Klinikum Rosenheim

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study Start: 2020-08-04
• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-08-31
• Last Update Submitted: 2020-08-31
• Study First Posted: 2020-09-04
• Last Update Posted: 2020-09-04
• Primary Completion: 2022-03-27
• Study Completion: 2022-03-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
POBA	conventional balloon angioplasty	Intervention with regular baloon
Chocolate PTA balloon	Chocolate PTA Balloon	-

Primary Outcome Measures

Name	Time	Method
Recoil (lumen loss > 30%) 15-30 min after study intervention angiographically documented and analyzed by a core-lab	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

Secondary Outcome Measures

Name	Time	Method
the loss of patency greater than 50% in the MRA after six month	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%
the re-occlusion rate at 6 months (measured by MRA)	6 month	lumen = 0 mm = recocclusion
Residual stenosis (MLD post compared to RVD, % of RVD) >50% after the invention	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
Wound status at 1 and 6 months:	1 and 6 months	as estimated by the patient (healed, improved, no change, worsened)
target lesion revascularization TLR rate at 1 and 6 months	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	1 and 6 months
Clinical presentation (Rutherford 0, 1, 2, 3, 4, 5 or 6 at 30 days and 6 months	1 and 6 month	Rutherford 0 = no symptoms, Rutherford 6 = worst symptoms
Ancle brachial index (ABI) compared to baseline and post intervention and 6 months	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)
DUS vs. MRA at 6 months	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

Trial Locations

Locations (8)

Hanusch-Krankenhaus Kardiovaskuläres Zentrum; 🇦🇹 Wien, Austria

Elblandklinikum Radebeul Interdisziplinäres Gefäßzentrum Radebeul / Riesa; 🇩🇪 Radebeul, Germany

SRH Klinikum Karlsbad-Langensteinbach GmbH; 🇩🇪 Karlsbad (Baden), Baden-Wuettenberg, Germany

Herzzentrum Bad Krozingen; 🇩🇪 Bad Krozingen, BW, Germany

Tepe; 🇩🇪 Rosenheim, BW, Germany

LKH-Univ. Klinikum Graz; 🇦🇹 Graz, Austria

Uniklinik Tübingen; 🇩🇪 Tuebingen, BW, Germany

Auckland City Hospital; 🇳🇿 Grafton, New Zealand