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

Peripheral Vascular Disease Clinical Trial

— FEMOSEAL CLOSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05027698
• Other study ID #: T138E4
• Status: Completed
• Start date: December 27, 2021
• Est. completion date: August 3, 2022

Study information

• Verified date: September 2022
• Source: Terumo Europe N.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: August 3, 2022
• Est. primary completion date: July 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hemostasis
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Closure
• Vascular Diseases

Locations

Country	Name	City	State
Belgium	AZ Sint Blasius	Dendermonde
France	Hôpital Paris St Joseph, Vascular and endovascular surgical center	Paris
Germany	Universitäts-Herzzentrum Freiburg Bad Krozingen, Department of Cardiology and Angiology Department	Bad Krozingen	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Terumo Europe N.V.

Countries where clinical trial is conducted

Belgium,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Safety endpoint: Freedom from major complications	Freedom from major complications of the access site limb	within 6 hours post procedure
Secondary	Freedom from any minor complications at the target limb access site.	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
Secondary	Freedom from any major and minor complications at the target limb access site.		within 6 hours to 30 days post-procedure
Secondary	Time to hemostasis (TTH)	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
Secondary	Time to ambulation (TTA)	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
Secondary	Length of stay in hospital	i. e. the time between the procedural sheath removal and the moment when the patient is discharged from the hospital	up to 30 days
Secondary	Quality of Life assessment	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
Secondary	FemoSeal™ VCS usability	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