Status:
COMPLETED
FLUENCY® PLUS in the Treatment of Peripheral Artery Disease
Lead Sponsor:
C. R. Bard
Collaborating Sponsors:
Cromsource
Conditions:
Vascular Diseases, Peripheral
Eligibility:
All Genders
18+ years
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® PL...
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 saf...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 5 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT04765566
Start Date
February 5 2021
End Date
February 28 2022
Last Update
April 29 2022
Active Locations (6)
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1
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
2
Universitätsklinikum Regensburg
Regensburg, Germany, 93053
3
Klinikum Nordoberpfalz AG - Klinikum Weiden
Weiden, Germany, 92637
4
Medical University of Gdańsk
Gdansk, Poland, 80-214