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BEnefit of Arterial Preparation by LONGitudinal Scoring (BELONG)

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ClinicalTrials.gov Identifier: NCT03721939
Recruitment Status : Recruiting
First Posted : October 26, 2018
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
VentureMed Group Inc.

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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: FLEX Scoring Catheter Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BEnefit of Arterial Preparation by LONGitudinal Scoring Before Paclitaxel Eluting Balloon Angioplasty of the Superficial Femoral and Popliteal Artery
Actual Study Start Date : October 24, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Experimental: FLEX Scoring Catheter plus DEB
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.
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.




Primary Outcome Measures :
  1. Absence of clinically driven target lesion revascularization (CDTLR) at 12 months [ Time Frame: 12 months ]
  2. Occurrence of death from cardiovascular origin [ Time Frame: 12 months ]
  3. Occurrence of major amputation of target limb [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Primary patency of the treated lesion (defined by PSVR ≤ 2.5 at duplex scan) [ Time Frame: 3 and 12 months ]
  2. Absence of CDTLR [ Time Frame: 3 months ]
  3. Absence of major amputation [ Time Frame: 3 and 12 months ]
  4. Change in ankle brachial index (ABI) [ Time Frame: 3 and 12 months ]
  5. Change in Rutherford class of symptom [ Time Frame: 3 and 12 Months ]
  6. Technical success of the scoring procedure [ Time Frame: Average of 2 hours ]
  7. Proportion of luminal gain [ Time Frame: Average of 2 hours ]
  8. Occurrence of dissection [ Time Frame: Average of 2 hours ]
  9. Proportion of stent implantation [ Time Frame: Average of 2 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03721939


Contacts
Contact: Feeny 567 661 0768 kfeeny@venturemedgroup.com

Locations
Switzerland
Hôpital Cantonal de Fribourg Recruiting
Fribourg, Switzerland
Contact: Periard, MD         
Principal Investigator: Daniel Periard, MD         
Sub-Investigator: Rolf Engelberger, MD         
Sponsors and Collaborators
VentureMed Group Inc.
Investigators
Principal Investigator: Daniel Periard, MD Fribourg Cantonal Hospital

Responsible Party: VentureMed Group Inc.
ClinicalTrials.gov Identifier: NCT03721939     History of Changes
Other Study ID Numbers: BELONG Study
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases