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

NCT ID: NCT05027698

Last Updated: 2022-09-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 230 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-27
• Study Completion Date: 2022-08-03

Brief 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. 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.

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.

Conditions

Vascular Closure; Endovascular Procedure; Hemostasis; Peripheral Vascular Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Terumo Europe N.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AZ Sint Blasius

Dendermonde, , Belgium

Hôpital Paris St Joseph, Vascular and endovascular surgical center

Paris, , France

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

Bad Krozingen, Baden-Wurttemberg, Germany

Countries

Belgium; France; Germany

References

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.

Reference Type: DERIVED

PMID: 39985734 (View on PubMed)

Other Identifiers

T138E4

Identifier Type: -

Identifier Source: org_study_id