NCT04765566

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

February 5, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

9 months

First QC Date

February 4, 2021

Last Update Submit

April 28, 2022

Conditions

Vascular Diseases, Peripheral

Keywords

Iliac Artery DiseaseVascular Stent Graft

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Technical Success

    During Procedure

  • Procedural Success

    From Procedure until patient is discharged from hospital (average of 2 days)

  • Target Lesion Revascularization

    24 months, 36 months, 60 months

  • Target Vessel Revascularization

    12 months, 24 months, 36 months, 60 months

  • Sustained Clinical Success

    30 days, 12 months, 24 months, 36 months, 60 months

  • +2 more secondary outcomes

Interventions

Endovascular revascularization of peripheral arteriesDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients with iliac artery disease.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Universitätsklinikum Regensburg

Regensburg, 93053, Germany

Location

Klinikum Nordoberpfalz AG - Klinikum Weiden

Weiden, 92637, Germany

Location

Medical University of Gdańsk

Gdansk, 80-214, Poland

Location

Mazowiecki Szpital Specjalistyczny (MSS Ostroleka)

Ostrołęka, 07-410, Poland

Location

Mazowiecki Szpital Brodnowski

Warsaw, 03-242, Poland

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Grzegorz Halena, Prof.

    Medical University of Gdansk

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2021

First Posted

February 21, 2021

Study Start

February 5, 2021

Primary Completion

October 31, 2021

Study Completion

February 28, 2022

Last Updated

April 29, 2022

Record last verified: 2022-04

Locations

DE(3)PL(3)