FLUENCY® PLUS in the Treatment of Peripheral Artery Disease

A Retrospective, Multi-Center, Real World Study of the BD Bard FLUENCY® PLUS Vascular Stent Graft in the Treatment of Peripheral Artery Disease

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.

Study Overview

• Status: Completed
• Conditions: Vascular Diseases, Peripheral
• Intervention / Treatment: Device: Endovascular revascularization of peripheral arteries

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).

• Study Type: Observational
• Enrollment (Actual): 146

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg-Eppendorf
  • Regensburg, Germany, 93053
    • Universitätsklinikum Regensburg
  • Weiden, Germany, 92637
    • Klinikum Nordoberpfalz AG - Klinikum Weiden
• Poland
  • Gdańsk, Poland, 80-214
    • Medical University of Gdansk
  • Ostrołęka, Poland, 07-410
    • Mazowiecki Szpital Specjalistyczny (MSS Ostroleka)
  • Warsaw, Poland, 03-242
    • Mazowiecki Szpital Bródnowski

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients with iliac artery disease.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from major complications	Freedom from device- and/or procedure-related death or myocardial infarction (MI), or any Target Lesion Revascularization (TLR), or target limb major amputation (above the ankle) through 30 days following the index procedure.	30 days
Target Lesion Revascularization	Target Lesion Revascularization (TLR) through 12-months post-index procedure.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success	Proportions of lesions with technical success. Technical success is defined as the successful treatment of the target lesion at the index procedure using the FLUENCY® PLUS Vascular Stent Graft, as reported in the questionnaire by the Investigator.	During Procedure
Procedural Success	Proportions of patients with technical success and no peri-procedural complications (death, stroke, myocardial infarction (MI), emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel) prior to hospital discharge.	From Procedure until patient is discharged from hospital (average of 2 days)
Target Lesion Revascularization	Target Lesion Revascularization (TLR) through 24 (if applicable)-, 36 (if applicable)-, and 60 (if applicable)-months post-index procedure.	24 months, 36 months, 60 months
Target Vessel Revascularization	Target Vessel Revascularization (TVR) through 12-, 24 (if applicable)-,36 (if applicable) and 60 (if applicable)-months post-index procedure. TVR is defined as the first revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in the target vessel segment following the index procedure.	12 months, 24 months, 36 months, 60 months
Sustained Clinical Success	Proportions of patients with sustained cumulative improvement from baseline value of ≥ 1 Rutherford Category at 30-days and 12-, 24 (if applicable)-, 36 (if applicable) and 60 (if applicable)-months post-index procedure, as determined by the Investigator.	30 days, 12 months, 24 months, 36 months, 60 months
Primary Patency	Primary Patency at 12-, 24 (if applicable)-, 36 (if applicable)- and 60 (if applicable)- months post-index procedure (freedom from TLR and restenosis). Restenosis will be assessed by duplex ultrasonography (DUS) or angiography and is present when the target lesion is determined to have >50% stenosis, as determined by the Investigator.	12 months, 24 months, 36 months, 60 months
Puncture site complications	Presence of peri procedural complications and/or significant post-operative hematoma at puncture site, as determined by the Investigator.	From Procedure until patient is discharged from hospital (average of 2 days)

Collaborators and Investigators

• Sponsor: C. R. Bard
• Collaborators: Cromsource
• Investigators: Principal Investigator: Grzegorz Halena, Prof., Medical University of Gdansk

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2021
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 19, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Iliac Artery Disease; Vascular Stent Graft
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: BDPI-20-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No