An Observational Study to Evaluate Safety, Performance, a... | NCT07010354

Studies
An Observational Study to Evaluate Safety, Performance, and Clinical Benefit of BeFlow

NCT07010354

Sponsor

Bentley InnoMed GmbH

Status

Recruiting

Last Update Posted

Sep 19, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Iliac Artery Stenosis
Iliac Artery Occlusion

Interventions

Stenting

Countries

Belgium
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 8, 2025Actual

Primary Completion Date

Jul 31, 2026Estimated

Completion Date

Jul 31, 2031Estimated

First Submitted Date

May 28, 2025

First Submission Date that Met QC Criteria

Jun 6, 2025

First Posted Date

Jun 8, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2025

Last Update Posted Date

Sep 19, 2025Actual

Name	Class
ID3 Medical	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stenting	Device	Endovascular treatment of stenosed or occluded iliac arteries: Permanent intraluminal placement of a covered stent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary patency rate		12 months

Secondary Outcomes

Measure	Description	Time Frame
Rate of covered stent-related complications		1 month and 12 months
Rate of technical success	successful positioning and deployment of the stents	up to 1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Richard A Griesbach, Dr	Contact	+49 7471 9999 117		r.griesbach@bentley.global

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AZ Sint Blasius	Recruiting	Dendermonde		9200	Belgium

Intervention Browse Module

MeSH Terms

ID	Term
D015607	Stents

Ancestor Terms

ID	Term
D019736	Prostheses and Implants
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided