FLUENCY® PLUS in the Treatment of Peripheral Artery Disease

Vascular Diseases, Peripheral Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04765566
• Other study ID #: BDPI-20-001
• Status: Completed
• Start date: February 5, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: April 2022
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: February 28, 2022
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases
• Vascular Diseases, Peripheral

Intervention

Device:
• 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

Locations

Country	Name	City	State
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Universitätsklinikum Regensburg	Regensburg
Germany	Klinikum Nordoberpfalz AG - Klinikum Weiden	Weiden
Poland	Medical University of Gdansk	Gdansk
Poland	Mazowiecki Szpital Specjalistyczny (MSS Ostroleka)	Ostroleka
Poland	Mazowiecki Szpital Brodnowski	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
C. R. Bard	Cromsource

Countries where clinical trial is conducted

Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Target Lesion Revascularization	Target Lesion Revascularization (TLR) through 12-months post-index procedure.	12 months
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)