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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03721939
Other study ID # BELONG Study
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 24, 2018
Est. completion date December 2021

Study information

Verified date October 2020
Source VentureMed Group Inc.
Contact Jill Schweiger
Phone 763-296-2021
Email Jschweiger@venturemedgroup.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the artery preparation concept is to perform regular longitudinal micro-incisions on the inner side of the artery ("scoring") and therefore promote a regular expansion of atheroma by balloon inflation.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients = 18-year-old, with symptomatic lower extremity occlusive arterial disease - Rutherford class of symptom 2 to 5 - Atheromatous = 70 % stenosis or occlusion of SFA and/or PA - Absence of > 50% residual stenosis of the run-in vessels at the end of procedure - Presence of at least one patent (no = 50 % stenosis) run-off tibial or fibular vessel to the foot at the end of procedure - De novo or restenotic lesions, including in-stent restenosis - Willingness to participate in the study and signature of informed consent Exclusion Criteria: - Renal failure with glomerular filtration rate (GFR) 30 ml/min or below, estimated by the Cockroft-Gault equation. - Women who are pregnant, lactating, or planning to become pregnant during the duration of the study - Recent artery thrombosis, at risk of distal embolization during percutaneous procedure - Previous use of a PCB in the lesion during last 15 months - Extremely calcified lesions, defined by calcification involving ³ 270° of the artery circumference over ³ 15 cm. - Sub-intimal recanalization - Tortuous contra-lateral femoral access with difficult cross-over - Previous or planned surgery of the target lesion - High risk of bleeding - Contra-indication to dual antiplatelet therapy for one month, and/or to single antiplatelet therapy for 1 year - Allergy to aspirin, clopidogrel or heparin - Life expectancy less than one year

Study Design


Intervention

Device:
FLEX Scoring Catheter
Vessel preparation with the FLEX Scoring Catheter® with a 30° rotation between each passage is performed, followed by a DEB angioplasty.

Locations

Country Name City State
Switzerland Hôpital Cantonal de Fribourg Fribourg

Sponsors (1)

Lead Sponsor Collaborator
VentureMed Group Inc.

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Absence of clinically driven target lesion revascularization (CDTLR) at 12 months 12 months
Primary Occurrence of death from cardiovascular origin 12 months
Primary Occurrence of major amputation of target limb 12 months
Secondary Primary patency of the treated lesion (defined by PSVR = 2.5 at duplex scan) 3 and 12 months
Secondary Absence of CDTLR 3 months
Secondary Absence of major amputation 3 and 12 months
Secondary Change in ankle brachial index (ABI) 3 and 12 months
Secondary Change in Rutherford class of symptom 3 and 12 Months
Secondary Technical success of the scoring procedure Average of 2 hours
Secondary Proportion of luminal gain Average of 2 hours
Secondary Occurrence of dissection Average of 2 hours
Secondary Proportion of stent implantation Average of 2 hours
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