Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Daniel Périard
Previous Study | Return to List | Next Study

BEnefit of Arterial Preparation by LONGitudinal Scoring (BELONG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE October 21, 2018
First Posted Date  ICMJE October 26, 2018
Last Update Posted Date January 7, 2019
Actual Study Start Date  ICMJE October 24, 2018
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2018)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2018)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BEnefit of Arterial Preparation by LONGitudinal Scoring
Official Title  ICMJE BEnefit of Arterial Preparation by LONGitudinal Scoring Before Paclitaxel Eluting Balloon Angioplasty of the Superficial Femoral and Popliteal Artery
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Arterial Disease
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Device: FLEX Scoring Catheter
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 25, 2018)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Feeny 567 661 0768 kfeeny@venturemedgroup.com
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03721939
Other Study ID Numbers  ICMJE BELONG Study
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party VentureMed Group Inc.
Study Sponsor  ICMJE VentureMed Group Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel Periard, MD Fribourg Cantonal Hospital
PRS Account VentureMed Group Inc.
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP