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

September 23, 2022 updated by: Terumo Europe N.V.

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Dendermonde, Belgium, 9200
        • AZ Sint Blasius
      • Paris, France, 75014
        • Hôpital Paris St Joseph, Vascular and endovascular surgical center
    • Baden-Württemberg
      • Bad Krozingen, Baden-Württemberg, Germany, 79189
        • Universitäts-Herzzentrum Freiburg Bad Krozingen, Department of Cardiology and Angiology Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study will include patients undergoing diagnostic or interventional endovascular procedures in which FemoSeal™ VCS is used as per it's IFU.

Description

Inclusion Criteria:

  1. Subject is ≥ 18 years old
  2. Subject is willing and able to complete the follow-up requirements
  3. 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)
  4. Patient undergoing diagnostic or interventional endovascular procedure compatible with the use of FemoSeal™ VCS
  5. Puncture site located at the CFA (i.e. between the inferior epigastric artery and the bifurcation of the superficial and profunda femoral arteries)
  6. 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

Exclusion Criteria:

  1. Any contraindication to the endovascular treatment and/or FemoSeal™ VCS use as per IFU
  2. Use of the FemoSeal™ VCS on puncture sites other than CFA
  3. Repuncture of the CFA within 90 days at the same access site
  4. 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:

  5. Lumen diameter of CFA < 5 mm
  6. Stenosis and/or significant plaque present in the vicinity of the CFA puncture site
  7. Arterial puncture is at, or distal to, the femoral artery bifurcation
  8. Anomalous branches or vessel abnormalities present in the vicinity of the CFA puncture site
  9. Use of > 7F primary introducer sheaths or devices
  10. Multiple femoral punctures
  11. Known or suspected posterior femoral wall puncture
  12. Any condition that would make use of the closure device inappropriate (as per investigators' discretion)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness endpoint: Successful puncture site haemostasis
Time Frame: within 6 hours post procedure
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.
within 6 hours post procedure
Safety endpoint: Freedom from major complications
Time Frame: within 6 hours post procedure
Freedom from major complications of the access site limb
within 6 hours post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from any minor complications at the target limb access site.
Time Frame: within 6 hours post procedure

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)
within 6 hours post procedure
Freedom from any major and minor complications at the target limb access site.
Time Frame: within 6 hours to 30 days post-procedure
within 6 hours to 30 days post-procedure
Time to hemostasis (TTH)
Time Frame: up to 1 day
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.
up to 1 day
Time to ambulation (TTA)
Time Frame: up to 30 days
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.
up to 30 days
Length of stay in hospital
Time Frame: up to 30 days
i. e. the time between the procedural sheath removal and the moment when the patient is discharged from the hospital
up to 30 days
Quality of Life assessment
Time Frame: at baseline, discharge , and 30 days

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.

at baseline, discharge , and 30 days
FemoSeal™ VCS usability
Time Frame: up to 1 day
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.
up to 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 27, 2021

Primary Completion (ACTUAL)

July 4, 2022

Study Completion (ACTUAL)

August 3, 2022

Study Registration Dates

First Submitted

August 13, 2021

First Submitted That Met QC Criteria

August 25, 2021

First Posted (ACTUAL)

August 30, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 26, 2022

Last Update Submitted That Met QC Criteria

September 23, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Peripheral Vascular Disease

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