Back to resultsBEnefit of Arterial Preparation by LONGitudinal Scoring (BELONG)
Primary Purpose
Peripheral Arterial Disease
Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
FLEX Scoring Catheter
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease
Eligibility Criteria
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
Sites / Locations
- Hôpital Cantonal de FribourgRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FLEX Scoring Catheter plus DEB
Arm Description
The target lesion is prepared by the FLEX Scoring Catheter® with a 30° rotation between each passage. Angioplasty is performed during 3 minutes with paclitaxel-coated balloon(s) (PCB), all along the target lesion.
Outcomes
Primary Outcome Measures
Absence of clinically driven target lesion revascularization (CDTLR) at 12 months
Occurrence of death from cardiovascular origin
Occurrence of major amputation of target limb
Secondary Outcome Measures
Primary patency of the treated lesion (defined by PSVR ≤ 2.5 at duplex scan)
Absence of CDTLR
Absence of major amputation
Change in ankle brachial index (ABI)
Change in Rutherford class of symptom
Technical success of the scoring procedure
Proportion of luminal gain
Occurrence of dissection
Proportion of stent implantation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03721939
Brief Title
BEnefit of Arterial Preparation by LONGitudinal Scoring
Acronym
BELONG
Official Title
BEnefit of Arterial Preparation by LONGitudinal Scoring Before Paclitaxel Eluting Balloon Angioplasty of the Superficial Femoral and Popliteal Artery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 24, 2018 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VentureMed Group Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FLEX Scoring Catheter plus DEB
Arm Type
Experimental
Arm Description
The target lesion is prepared by the FLEX Scoring Catheter® with a 30° rotation between each passage. Angioplasty is performed during 3 minutes with paclitaxel-coated balloon(s) (PCB), all along the target lesion.
Intervention Type
Device
Intervention Name(s)
FLEX Scoring Catheter
Intervention Description
Vessel preparation with the FLEX Scoring Catheter® with a 30° rotation between each passage is performed, followed by a DEB angioplasty.
Primary Outcome Measure Information:
Title
Absence of clinically driven target lesion revascularization (CDTLR) at 12 months
Time Frame
12 months
Title
Occurrence of death from cardiovascular origin
Time Frame
12 months
Title
Occurrence of major amputation of target limb
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Primary patency of the treated lesion (defined by PSVR ≤ 2.5 at duplex scan)
Time Frame
3 and 12 months
Title
Absence of CDTLR
Time Frame
3 months
Title
Absence of major amputation
Time Frame
3 and 12 months
Title
Change in ankle brachial index (ABI)
Time Frame
3 and 12 months
Title
Change in Rutherford class of symptom
Time Frame
3 and 12 Months
Title
Technical success of the scoring procedure
Time Frame
Average of 2 hours
Title
Proportion of luminal gain
Time Frame
Average of 2 hours
Title
Occurrence of dissection
Time Frame
Average of 2 hours
Title
Proportion of stent implantation
Time Frame
Average of 2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jill Schweiger
Phone
763-296-2021
Email
Jschweiger@venturemedgroup.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Periard, MD
Organizational Affiliation
Fribourg Cantonal Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Cantonal de Fribourg
City
Fribourg
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Periard, MD
First Name & Middle Initial & Last Name & Degree
Daniel Periard, MD
First Name & Middle Initial & Last Name & Degree
Rolf Engelberger, MD
12. IPD Sharing Statement
Learn more about this trial
BEnefit of Arterial Preparation by LONGitudinal Scoring
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