Ignite Creation Date:
2024-05-06 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05335525
Status:
RECRUITING
Last Update Posted:
2023-04-20
First Post:
2022-04-12
Brief Title:
Post-market Clinical Investigation of the Angio-Seal VIP VCD ANGIO-SEAL CLOSE
Sponsor:
Terumo Europe NV
Organization:
Terumo Europe NV
Study Overview
Official Title:
Post-market Clinical Investigation of the Angio-Seal VIP VCD A Prospective Multi-center Observational Study ANGIO-SEAL CLOSE
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None