CHOCO-CABANA Trial

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04539145
• Other study ID #: RO-012020
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: August 4, 2020
• Est. completion date: March 27, 2022

Study information

• Verified date: August 2020
• Source: Klinikum Rosenheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: March 27, 2022
• Est. primary completion date: March 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Device:
• Chocolate PTA Balloon
Chocolate PTA Balloon
• conventional balloon angioplasty
conventional bal-loon angioplasty

Locations

Country	Name	City	State
Austria	LKH-Univ. Klinikum Graz	Graz
Austria	Hanusch-Krankenhaus Kardiovaskuläres Zentrum	Wien
Germany	Herzzentrum Bad Krozingen	Bad Krozingen	BW
Germany	SRH Klinikum Karlsbad-Langensteinbach GmbH	Karlsbad (Baden)	Baden-Wuettenberg
Germany	Elblandklinikum Radebeul Interdisziplinäres Gefäßzentrum Radebeul / Riesa	Radebeul
Germany	Tepe	Rosenheim	BW
Germany	Uniklinik Tübingen	Tuebingen	BW
New Zealand	Auckland City Hospital	Grafton

Sponsors (12)

Lead Sponsor

Collaborator

Klinikum Rosenheim

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

Countries where clinical trial is conducted

Austria,  Germany,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	the re-occlusion rate at 6 months (measured by MRA)	lumen = 0 mm = recocclusion	6 month
Secondary	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
Secondary	Wound status at 1 and 6 months:	as estimated by the patient (healed, improved, no change, worsened)	1 and 6 months
Secondary	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
Secondary	Amputation rate at 1 and 6 months		1 and 6 months
Secondary	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
Secondary	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
Secondary	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