NCT03721939

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

October 24, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2018

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2024

Completed
Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

4.3 years

First QC Date

October 21, 2018

Last Update Submit

December 6, 2024

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (3)

  • Absence of clinically driven target lesion revascularization (CDTLR) at 12 months

    12 months

  • Occurrence of death from cardiovascular origin

    12 months

  • Occurrence of major amputation of target limb

    12 months

Secondary Outcomes (9)

  • Primary patency of the treated lesion (defined by PSVR ≤ 2.5 at duplex scan)

    3 and 12 months

  • Absence of CDTLR

    3 months

  • Absence of major amputation

    3 and 12 months

  • Change in ankle brachial index (ABI)

    3 and 12 months

  • Change in Rutherford class of symptom

    3 and 12 Months

  • +4 more secondary outcomes

Study Arms (1)

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.

Device: FLEX Scoring Catheter

Interventions

FLEX Scoring CatheterDEVICE

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

FLEX Scoring Catheter plus DEB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Cantonal de Fribourg

Fribourg, Switzerland

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Daniel Periard, MD

    Fribourg Cantonal Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2018

First Posted

October 26, 2018

Study Start

October 24, 2018

Primary Completion

January 25, 2023

Study Completion

March 4, 2024

Last Updated

December 12, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)