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

NCT05027698 | Completed

• 1 other identifier: T138E4
• Study Type: observational
• Target: 230
• Locations: 3 countries
• Sites: 3

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.

Conditions

Vascular Closure; Endovascular Procedure; Hemostasis; Peripheral Vascular Disease

Keywords

peripheral intervention; CFA arteriotomy closure; common femoral artery access site; vascular closure device

Outcome Measures

Primary Outcomes (2)

• 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.

  within 6 hours post procedure

• Safety endpoint: Freedom from major complications

  Freedom from major complications of the access site limb

  within 6 hours post procedure

Secondary Outcomes (7)

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

  within 6 hours post procedure

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

  within 6 hours to 30 days post-procedure

• Time to hemostasis (TTH)

  up to 1 day

• Time to ambulation (TTA)

  up to 30 days

• Length of stay in hospital

  up to 30 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Terumo Europe N.V.: lead

Study Sites (3)

AZ Sint Blasius

Dendermonde, 9200, Belgium

Location

Hôpital Paris St Joseph, Vascular and endovascular surgical center

Paris, 75014, France

Location

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

Bad Krozingen, Baden-Wurttemberg, 79189, Germany

Location

Related Publications (1)

• 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.

  PMID: 39985734 DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 30, 2021
• Study Start: December 27, 2021
• Primary Completion: July 4, 2022
• Study Completion: August 3, 2022
• Last Updated: September 26, 2022

Record last verified: 2022-09

Locations

DE (1); BE (1); FR (1)