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Vascular ClosureFEMOSEAL CLOSENCT05027698

Post-Market Clinical Investigation of the FemoSeal™ VCS: A Prospective, Multi-Center Observational European Study

An observational study of Vascular Closure and Endovascular Procedure, run by Terumo Europe N.V. at 3 sites in 3 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

The study aims to further demonstrate the safety and effectiveness of the FemoSeal™ VCS in achieving hemostasis following percutaneous endovascular procedures performed via the common femoral artery (CFA) access site. Read more about this study

Who is it for?
Ages 18 years and older
How many people
230 participants
Where
3 sitesin 3 countries
Study dates
27 Dec 2021to 3 Aug 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: The study will include patients undergoing diagnostic or interventional endovascular procedures in which FemoSeal™ VCS is used as per it's IFU.

Who may be able to join

  • Subject is ≥ 18 years old
  • Subject is willing and able to complete the follow-up requirements
  • Subject has the mental capacity (i.e. does not require the use of a Legally Authorized Representative) to sign the study Informed Consent Form (ICF)
  • Patient undergoing diagnostic or interventional endovascular procedure compatible with the use of FemoSeal™ VCS
  • Puncture site located at the CFA (i.e. between the inferior epigastric artery and the bifurcation of the superficial and profunda femoral arteries)
  • FemoSeal™ VCS deployed as per instruction for use by a trained operator on arteriotomy where sheaths or devices of ≤7F were used, following a femoral artery angiogram

Who cannot join

  • Any contraindication to the endovascular treatment and/or FemoSeal™ VCS use as per IFU
  • Use of the FemoSeal™ VCS on puncture sites other than CFA
  • Repuncture of the CFA within 90 days at the same access site
  • Enrollment of a patient with the contralateral CFA puncture, when a prior target limb access site has been selected for the study and a FemoSealTM deployment has been performed.
  • Additionally, patients will be examined intraoperatively and excluded from the study if any of the following were observed by the treating physician:
  • Lumen diameter of CFA < 5 mm
Show all 13Show fewer
  • Stenosis and/or significant plaque present in the vicinity of the CFA puncture site
  • Arterial puncture is at, or distal to, the femoral artery bifurcation
  • Anomalous branches or vessel abnormalities present in the vicinity of the CFA puncture site
  • Use of > 7F primary introducer sheaths or devices
  • Multiple femoral punctures
  • Known or suspected posterior femoral wall puncture
  • Any condition that would make use of the closure device inappropriate (as per investigators' discretion)

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Belgium1 site

  • AZ Sint Blasius

    Dendermonde, 9200

Other trials in Belgium

France1 site

  • Hôpital Paris St Joseph, Vascular and endovascular surgical center

    Paris, 75014

Other trials in France

Germany1 site

  • Universitäts-Herzzentrum Freiburg Bad Krozingen, Department of Cardiology and Angiology Department

    Bad Krozingen, Baden-Wurttemberg, 79189

Other trials in Germany

About this study

Official title: FEMOSEAL CLOSE - Post-Market Clinical Investigation of the FemoSeal™ VCS: A Prospective, Multi-Center Observational European Study

The study aims to further demonstrate the safety and effectiveness of the FemoSeal™ VCS in achieving hemostasis following percutaneous endovascular procedures performed via the common femoral artery (CFA) access site. This study is conducted in real-world subjects according to the FemoSeal™ VCS instruction for use (IFU), as part of the study device post-market clinical follow up surveillance plan and prospective clinical evidence collection.

Read the detailed description

The proposed Post-Market Clinical Follow-up study is a Prospective, Multi-Center, Observational Study, aiming to further demonstrate the safety and effectiveness of the FemoSealTM VCS in achieving hemostasis of common femoral artery (CFA) access site in real-world subjects undergoing percutaneous endovascular procedures. 230 patients will be enrolled at up to 6 European sites. Follow-ups are scheduled at 30 days (±7 days) by hospital visit or telephone call.

The sponsor shall provide training and the necessary guidelines to assist each investigation site on the data collection in the eCRF. Each site is responsible to report the available data requested by the CIP. In order to ensure data quality, validation \& consistency, edit checks will be designed during database development. Data Management team and the study monitors will be responsible to review the data and raise queries in the eCRF. Data cleaning will be done in regular intervals specified in Data Monitoring Plan. The final clean standardised datasets will be available prior to database lock for data analysis. An audit trail logging all data entered and edited is available within the EDC system. All source documents are maintained in the hospital files ready for inspection by the Sponsor and regulatory authorities upon request. The Sponsor will inform the investigator of the time period for retaining these records as per applicable regulatory requirements.

The study will be monitored at all stages of its development by study monitors appointed by the sponsor. Study monitors are designated as Sponsor representatives and are assigned to oversee the conduct and progress of the study at each site in accordance with the Monitoring Plan established for this clinical investigation.

Keywords
peripheral intervention, CFA arteriotomy closure, common femoral artery access site, vascular closure device
Medical subject headings
Peripheral Vascular Diseases

What is being measured

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

  1. Effectiveness endpoint: Successful puncture site haemostasis

    Cessation of arterial bleeding (excluding oozing) achieved in the CathLab in subjects not requiring any adjunctive intervention at the access site, including (but not limited to) sterile wound dressing and/or manual compression.

    Measured: within 6 hours post procedure

  2. Safety endpoint: Freedom from major complications

    Freedom from major complications of the access site limb

    Measured: within 6 hours post procedure

Secondary outcomes (7)

  1. Freedom from any minor complications at the target limb access site.

    Minor complications are defined as:

    • Any puncture site-related haematoma (i.e. a palpable groin swelling measured at the longest diameter)
    • Minor (<5 cm) or
    • Major (≥5 cm)
    • Pseudoaneurysms attributable to the study device
    • Arteriovenous fistulas
    • Minor access site infections (i.e. all infections not defined as major)

    Measured: within 6 hours post procedure

  2. Freedom from any major and minor complications at the target limb access site.

    Measured: within 6 hours to 30 days post-procedure

  3. Time to hemostasis (TTH)

    Defined as time between the removal of the procedural sheath up to first observed arterial bleeding cessation (excluding oozing at access site) in subjects not requiring adjunctive intervention in the cathlab.

    Measured: up to 1 day

  4. Time to ambulation (TTA)

    Defined as the time between the procedural sheath removal and the moment when the patient is able to ambulate, i.e. autonomously stand up from the bed and walk without recurrent bleeding.

    Measured: up to 30 days

  5. Length of stay in hospital

    1. e. the time between the procedural sheath removal and the moment when the patient is discharged from the hospital

    Measured: up to 30 days

  6. Quality of Life assessment

    Quality of Life assessed as per EuroQl five-dimensional (EQ-5D) questionnaire:

    The first part of the questionnaire contain descriptive questions on 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression, each with 5 levels of responses.

    The second part of the questionnaire contains a standard vertical 20-cm visual analog scale that is calibrated from 'the worst health you can imagine' (scored 0) at its base to 'the best health you can imagine' (scored 100) at its apex.

    Measured: at baseline, discharge , and 30 days

  7. FemoSeal™ VCS usability

    Accessed by questionnaire, including, but not limited to the following items (usefulness; ease of use; ease of learning; satisfaction and intention to use) completed by operators.

    Measured: up to 1 day

Timeline

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

  1. First posted30 Aug 2021
  2. Study start27 Dec 2021
  3. Primary completion4 Jul 2022
  4. Study completion3 Aug 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
Other
Time perspective
Prospective
Enrolment
230 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05027698
Sponsor's protocol ID
T138E4
Acronym
FEMOSEAL CLOSE
Status last verified
Sep 2022
First submitted
13 Aug 2021
Last updated
26 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Goueffic Y, Deloose K, Dubosq M, Zeller T. FEMOSEAL CLOSE: multi-centre observational study with FemoSeal vascular closure device following peripheral percutaneous endovascular procedures. CVIR Endovasc. 2025 Feb 22;8(1):15. doi: 10.1186/s42155-025-00522-5.

    PubMed 39985734

Questions about this trial

What is this clinical trial studying?

An observational study of Vascular Closure and Endovascular Procedure, run by Terumo Europe N.V. at 3 sites in 3 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 6 inclusion and 13 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 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium, France, Germany. 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?

Effectiveness endpoint: Successful puncture site haemostasis (time frame: within 6 hours post procedure). 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 NCT05027698, which also lists 1 linked publication.

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 26 Sep 2022.

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