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Completed

NCT Number: NCT03721939

BEnefit of Arterial Preparation by LONGitudinal Scoring

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Cantonal de Fribourg

Fribourg, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FLEX Scoring Catheter

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

VentureMed Group Inc.

Industry

Registry information

Official study title

BEnefit of Arterial Preparation by LONGitudinal Scoring Before Paclitaxel Eluting Balloon Angioplasty of the Superficial Femoral and Popliteal Artery

Acronym: BELONG

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Oct 26, 2018
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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