NCT05335525

Post-market Clinical Investigation of the Angio-Seal™ VIP VCD (ANGIO-SEAL CLOSE)

Post-market Clinical Investigation of the Angio-Seal™ VIP VCD: A Prospective, Multi-center Observational Study (ANGIO-SEAL CLOSE)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 230 (estimated)
• Sponsor: Terumo Europe N.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The present post-market surveillance study aims to evaluate the safety and effectiveness of the Angio-SealTM VIP VCD in patients undergoing endovascular procedures via femoral access in real-world setting.

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 Angio-SealTM VIP VCD in achieving hemostasis of femoral artery access site in real-world subjects undergoing percutaneous endovascular procedures. 230 patients will be enrolled at up to 6 sites in Europe. 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 DMP. 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
• Femoral Artery

Interventions

Type	Name	Description
DEVICE	Closure of the femoral arterial puncture site	Patient will undergo a diagnostic or interventional endovascular procedure, compatible with the use of Angio-Seal™ VIP VCD.

Timeline

• Start date: 2022-09-30
• Primary completion: 2023-05-01
• Completion: 2023-05-01
• First posted: 2022-04-19
• Last updated: 2023-04-20

Locations

4 sites across 3 countries: France, Germany, Netherlands