FLUENCY® PLUS in the Treatment of Peripheral Artery Disease

NCT ID: NCT04765566

Last Updated: 2022-04-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 146 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-05
• Study Completion Date: 2022-02-28

Brief Summary

This is a retrospective, multi-center study to assess the safety and performance by proactively reviewing pre-existing medical records and imaging of patients who had previous placement of FLUENCY® PLUS Vascular Stent Graft in iliac artery vessel(s) between January 2010 and March 2020.

Detailed Description

The purpose of this study is to retrospectively collect and analyze data on the FLUENCY® PLUS Vascular Stent Graft to summarize and describe real-world experience, and long-term data regarding its safety and efficacy and to compare these findings with published data on stent-treatment in iliac artery disease. The present study aims to collect clinical data about FLUENCY® treatment of atherosclerotic disease (stenosis, occlusion, dissection) as well as to explore safety and effectiveness data for off-label use in additional indications in the iliac segment that have been described in the scientific literature (vessel rupture, aneurysm).

Conditions

Vascular Diseases, Peripheral

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Endovascular revascularization of peripheral arteries

Endovascular revascularization of peripheral arteries involves placement of a self-expanding Nitinol Stent encapsulated with ePTFE in diseased vessel segments

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• The FLUENCY® PLUS Vascular Stent Graft implantation procedure was for the purpose of lesions in the iliac arteries.
• The FLUENCY® PLUS Vascular Stent Graft was placed between January 2010 and March 2020.
• Male or female ≥ 18 years old at the time of implantation.
• The subject provides written informed consent. The subject may be enrolled without informed consent for anonymous data collection if the responsible Ethics Committee has waived the requirement due to the retrospective study design, and written documentation about this decision is provided to the Investigator and the Sponsor.

Exclusion Criteria

• The FLUENCY® PLUS Vascular Stent Graft was implanted in an anatomic location other than iliac arteries.
• Absence of a target lesion (i.e. diseased or damaged artery) in the area covered by the FLUENCY® PLUS Vascular Stent Graft.
• Subjects without any existing follow-up information after hospital discharge (This criterion does not apply to subjects who deceased during implantation/prior to discharge).
• The subject was identified with a medical condition, which, in the opinion of the Investigator, may cause him/her to be noncompliant with the protocol, or confound the data interpretation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cromsource

INDUSTRY

Sponsor Role: collaborator

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grzegorz Halena, Prof.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Gdansk

Locations

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Universitätsklinikum Regensburg

Regensburg, , Germany

Klinikum Nordoberpfalz AG - Klinikum Weiden

Weiden, , Germany

Medical University of Gdańsk

Gdansk, , Poland

Mazowiecki Szpital Specjalistyczny (MSS Ostroleka)

Ostrołęka, , Poland

Mazowiecki Szpital Brodnowski

Warsaw, , Poland

Countries

Germany; Poland

Other Identifiers

BDPI-20-001

Identifier Type: -

Identifier Source: org_study_id