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Vascular Diseases, PeripheralNCT04765566

FLUENCY® PLUS in the Treatment of Peripheral Artery Disease

An observational study of Vascular Diseases, Peripheral, run by C. R. Bard at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Vascular Diseases, Peripheral
What is being tested?
Endovascular revascularization of peripheral arteries
Type of treatment
Medical device
How many people
146 participants
Where
6 sitesin 2 countries
Study dates
5 Feb 2021to 28 Feb 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients with iliac artery disease.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Germany3 sites

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Universitätsklinikum Regensburg

    Regensburg, 93053

  • Klinikum Nordoberpfalz AG - Klinikum Weiden

    Weiden, 92637

Other trials in Germany

Poland3 sites

  • Medical University of Gdańsk

    Gdansk, 80-214

  • Mazowiecki Szpital Specjalistyczny (MSS Ostroleka)

    Ostrołęka, 07-410

  • Mazowiecki Szpital Brodnowski

    Warsaw, 03-242

Other trials in Poland

About this study

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

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.

Read the 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).

Being tested
Endovascular revascularization of peripheral arteries
Keywords
Iliac Artery Disease, Vascular Stent Graft
Medical subject headings
Peripheral Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30 days

  2. Target Lesion Revascularization

    Target Lesion Revascularization (TLR) through 12-months post-index procedure.

    Measured: 12 months

Secondary outcomes (7)

  1. 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.

    Measured: During Procedure

  2. 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.

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

  3. Target Lesion Revascularization

    Target Lesion Revascularization (TLR) through 24 (if applicable)-, 36 (if applicable)-, and 60 (if applicable)-months post-index procedure.

    Measured: 24 months, 36 months, 60 months

  4. 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.

    Measured: 12 months, 24 months, 36 months, 60 months

  5. 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.

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

  6. 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.

    Measured: 12 months, 24 months, 36 months, 60 months

  7. Puncture site complications

    Presence of peri procedural complications and/or significant post-operative hematoma at puncture site, as determined by the Investigator.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2021
  2. Study start5 Feb 2021
  3. Primary completion31 Oct 2021
  4. Study completion28 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04765566
Sponsor's protocol ID
BDPI-20-001
Status last verified
Apr 2022
First submitted
4 Feb 2021
Last updated
29 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Vascular Diseases, Peripheral, run by C. R. Bard at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from major complications (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04765566.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.

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