BEnefit of Arterial Preparation by LONGitudinal Scoring (BELONG)

V

VentureMed

Status

Unknown

Conditions

Peripheral Arterial Disease

Treatments

Device: FLEX Scoring Catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT03721939
BELONG Study

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

150 participants in 1 patient group

FLEX Scoring Catheter plus DEB
Experimental group
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.
Treatment:
Device: FLEX Scoring Catheter

Trial contacts and locations

0

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Central trial contact

Jill Schweiger

Data sourced from clinicaltrials.gov

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