NCT07010354

Brief Summary

This international, observational multi-centre study of the device BFI will monitor technical success of the implantation, data regarding clinical performance, clinical benefit, as well as potential unknown side effects pursuant to the Intended Purpose.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
64mo left

Started Aug 2025

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
recruiting

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

Study Progress13%
Aug 2025Jul 2031

First Submitted

Initial submission to the registry

May 28, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 8, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

August 8, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2031

Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

12 months

First QC Date

May 28, 2025

Last Update Submit

September 15, 2025

Conditions

Iliac Artery StenosisIliac Artery Occlusion

Outcome Measures

Primary Outcomes (1)

  • Primary patency rate

    12 months

Secondary Outcomes (9)

  • Rate of covered stent-related complications

    1 month and 12 months

  • Rate of technical success

    up to 1 month

  • Primary patency rate

    up to 60 months

  • Secondary patency rate

    up to 60 months

  • Primary assisted patency rate

    up to 60 months

  • +4 more secondary outcomes

Interventions

StentingDEVICE

Endovascular treatment of stenosed or occluded iliac arteries: Permanent intraluminal placement of a covered stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients (≥ 18 years of age) suffering from stenotic lesions in the iliac arteries caused by arteriosclerosis or other pathologies that may be treated by stenting.

You may qualify if:

  • Patients with an indication for permanent intraluminal placement in iliac arteries for restoring and improving the patency impaired by arteriosclerosis or other stenoses that may be treated by stenting according to the IFU of the BFI
  • Patient is capable and willing to sign an informed consent
  • Patients ≥18 years of age at the time of consent

You may not qualify if:

  • Patients with any contraindication according to the IFU
  • Previous stenting of the target vessel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AZ Sint Blasius

Dendermonde, 9200, Belgium

RECRUITING

EOC - Ente Ospedaliero Cantonale

Lugano, Canton Ticino, 6900, Switzerland

NOT YET RECRUITING

MeSH Terms

Interventions

Stents

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Central Study Contacts

Richard A Griesbach, Dr

CONTACT

+49 7471 9999 117r.griesbach@bentley.global

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2025

First Posted

June 8, 2025

Study Start

August 8, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2031

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations

BE(1)CH(1)