Clinical trial NCT04765566: FLUENCY® PLUS in the Treatment of Peripheral Artery Disease
Official title: A Retrospective, Multi-Center, Real World Study of the BD Bard FLUENCY® PLUS Vascular Stent Graft in the Treatment of Peripheral Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Diseases, Peripheral
Keywords: Iliac Artery Disease
Vascular Stent Graft
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
Collaborators: name: Cromsource
First posted: 2021-02-21
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with iliac artery disease.

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).

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.

Primary outcomes:
measure: Freedom from major complications
timeFrame: 30 days
measure: Target Lesion Revascularization
timeFrame: 12 months
Secondary outcomes:
measure: Technical Success
timeFrame: During Procedure
measure: Procedural Success
timeFrame: From Procedure until patient is discharged from hospital (average of 2 days)
measure: Target Lesion Revascularization
timeFrame: 24 months, 36 months, 60 months
measure: Target Vessel Revascularization
timeFrame: 12 months, 24 months, 36 months, 60 months
measure: Sustained Clinical Success
timeFrame: 30 days, 12 months, 24 months, 36 months, 60 months
measure: Primary Patency
timeFrame: 12 months, 24 months, 36 months, 60 months
measure: Puncture site complications
timeFrame: From Procedure until patient is discharged from hospital (average of 2 days)
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Weiden
country: Germany
facility: Klinikum Nordoberpfalz AG - Klinikum Weiden
city: Gdańsk
country: Poland
facility: Medical University of Gdańsk
city: Ostrołęka
country: Poland
facility: Mazowiecki Szpital Specjalistyczny (MSS Ostroleka)
city: Warsaw
country: Poland
facility: Mazowiecki Szpital Brodnowski
Study officials:
affiliation: Medical University of Gdansk
name: Grzegorz Halena, Prof.
role: PRINCIPAL_INVESTIGATOR
References: