Clinical trial NCT05027698: Post-Market Clinical Investigation of the FemoSeal™ VCS: A Prospective, Multi-Center Observational European Study
Official title: FEMOSEAL CLOSE - Post-Market Clinical Investigation of the FemoSeal™ VCS: A Prospective, Multi-Center Observational European Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Closure
Endovascular Procedure
Hemostasis
Peripheral Vascular Disease
Keywords: peripheral intervention
CFA arteriotomy closure
common femoral artery access site
vascular closure device
Lead sponsor: Terumo Europe N.V.
Sponsor class: INDUSTRY
First posted: 2021-08-30
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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)

Primary outcomes:
measure: Effectiveness endpoint: Successful puncture site haemostasis
timeFrame: within 6 hours post procedure
measure: Safety endpoint: Freedom from major complications
timeFrame: within 6 hours post procedure
Secondary outcomes:
measure: Freedom from any minor complications at the target limb access site.
timeFrame: within 6 hours post procedure
measure: Freedom from any major and minor complications at the target limb access site.
timeFrame: within 6 hours to 30 days post-procedure
measure: Time to hemostasis (TTH)
timeFrame: up to 1 day
measure: Time to ambulation (TTA)
timeFrame: up to 30 days
measure: Length of stay in hospital
timeFrame: up to 30 days
measure: Quality of Life assessment
timeFrame: at baseline, discharge , and 30 days
measure: FemoSeal™ VCS usability
timeFrame: up to 1 day
Other outcomes:
Locations:
city: Dendermonde
country: Belgium
facility: AZ Sint Blasius
city: Paris
country: France
facility: Hôpital Paris St Joseph, Vascular and endovascular surgical center
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg Bad Krozingen, Department of Cardiology and Angiology Department
state: Baden-Württemberg
Study officials:
References: