Peripheral Arterial DiseaseBELONGNCT03721939
BEnefit of Arterial Preparation by LONGitudinal Scoring
A study testing FLEX Scoring Catheter in people with Peripheral Arterial Disease, run by VentureMed Group Inc. at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- FLEX Scoring Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Oct 2018to 4 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BEnefit of Arterial Preparation by LONGitudinal Scoring Before Paclitaxel Eluting Balloon Angioplasty of the Superficial Femoral and Popliteal Artery
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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- FLEX Scoring Catheter
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLEX Scoring CatheterDevice
Vessel preparation with the FLEX Scoring Catheter® with a 30° rotation between each passage is performed, followed by a DEB angioplasty.
| Study group | Role | What they receive |
|---|---|---|
| FLEX Scoring Catheter plus DEB | Experimental | 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. Receives: Device: FLEX Scoring Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of clinically driven target lesion revascularization (CDTLR) at 12 months
Measured: 12 months
Occurrence of death from cardiovascular origin
Measured: 12 months
Occurrence of major amputation of target limb
Measured: 12 months
Secondary outcomes (9)
Primary patency of the treated lesion (defined by PSVR ≤ 2.5 at duplex scan)
Measured: 3 and 12 months
Absence of CDTLR
Measured: 3 months
Absence of major amputation
Measured: 3 and 12 months
Change in ankle brachial index (ABI)
Measured: 3 and 12 months
Change in Rutherford class of symptom
Measured: 3 and 12 Months
Technical success of the scoring procedure
Measured: Average of 2 hours
Proportion of luminal gain
Measured: Average of 2 hours
Occurrence of dissection
Measured: Average of 2 hours
Proportion of stent implantation
Measured: Average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start24 Oct 2018
- Primary completion25 Jan 2023
- Study completion4 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- VentureMed Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Periard, MD, Principal investigator, Fribourg Cantonal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721939
- Sponsor's protocol ID
- BELONG Study
- Acronym
- BELONG
- Status last verified
- Dec 2024
- First submitted
- 21 Oct 2018
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BEnefit of Arterial Preparation by LONGitudinal Scoring Before Paclitaxel Eluting Balloon Angioplasty of the Superficial Femoral and Popliteal Artery
- ClinicalTrials.gov ID
- NCT03721939
- Acronym / sponsor ID
- BELONG / BELONG Study
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- VentureMed Group Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 4 Mar 2024 (actual)
- First posted
- 26 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLEX Scoring Catheter plus DEB | Experimental | Device: FLEX Scoring CatheterThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLEX Scoring CatheterVessel preparation with the FLEX Scoring Catheter® with a 30° rotation between each passage is performed, followed by a DEB angioplasty. | Device | FLEX Scoring Catheter plus DEB |
Primary outcome
Absence of clinically driven target lesion revascularization (CDTLR) at 12 months
Time frame: 12 months
Occurrence of death from cardiovascular origin
Time frame: 12 months
Occurrence of major amputation of target limb
Time frame: 12 months
9 secondary outcomes
Primary patency of the treated lesion (defined by PSVR ≤ 2.5 at duplex scan)
Time frame: 3 and 12 months
Absence of CDTLR
Time frame: 3 months
Absence of major amputation
Time frame: 3 and 12 months
Change in ankle brachial index (ABI)
Time frame: 3 and 12 months
Change in Rutherford class of symptom
Time frame: 3 and 12 Months
Technical success of the scoring procedure
Time frame: Average of 2 hours
Proportion of luminal gain
Time frame: Average of 2 hours
Occurrence of dissection
Time frame: Average of 2 hours
Proportion of stent implantation
Time frame: Average of 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Periard, MD principal investigator
Fribourg Cantonal Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLEX Scoring Catheter in people with Peripheral Arterial Disease, run by VentureMed Group Inc. at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of clinically driven target lesion revascularization (CDTLR) at 12 months (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.