Post-Market Clinical Investigation of the FemoSeal™ VCS: A Prospective, Multi-Center Observationa… (NCT05027698) | Clinical Trial Compass
CompletedNot Applicable
Post-Market Clinical Investigation of the FemoSeal™ VCS: A Prospective, Multi-Center Observational European Study
Belgium, France, Germany230 participantsStarted 2021-12-27
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject is ≥ 18 years old
âś“. Subject is willing and able to complete the follow-up requirements
âś“. 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
âś“. 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
Exclusion criteria
✕. 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
âś•. Repuncture of the CFA within 90 days at the same access site
âś•. 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.
âś•. Lumen diameter of CFA \< 5 mm
âś•. Stenosis and/or significant plaque present in the vicinity of the CFA puncture site
What they're measuring
1
Effectiveness endpoint: Successful puncture site haemostasis