Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT03423602
Status:
COMPLETED
Last Update Posted:
2023-02-01
First Post:
2018-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Performance Study of Large Hole Vascular Closure Device FIV
Sponsor:
Vivasure Medical Limited
Organization:
Study Overview
Official Title:
Clinical Investigation Plan (CIP) for Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER IV Study
Status:
COMPLETED
Status Verified Date:
2023-01
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:
Frontier-IV
Brief Summary:
The purpose of this Clinical Investigation Plan (CIP) is to:
1. Confirm the safety and performance of the PerQseal® large hole closure system.
2. To expand its indications of use to include common femoral arteriotomies created with 12 to 20 F sheaths in patients undergoing endovascular procedures.
1. Confirm the safety and performance of the PerQseal® large hole closure system.
2. To expand its indications of use to include common femoral arteriotomies created with 12 to 20 F sheaths in patients undergoing endovascular procedures.
Detailed Description:
This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the PerQseal® in 75 patients in approximately 10 European investigational sites.
The study shall not be blinded prior to, during or post the procedure. All patients undergoing an endovascular procedure requiring an arteriotomy created by 12 to 20 F sheaths, via the common femoral artery will be screened against the inclusion/exclusion criteria. If the patient meets the requirements of the clinical investigation, they shall be invited to participate, provide informed consent and shall subsequently be assigned a subject number.
All subjects shall have an immediately post procedure, \~24 hour, 1 and 3 month follow-up assessment. Safety data from the follow-ups will be assessed by the Data Safety Monitoring Committee on a continuous basis.
The study shall not be blinded prior to, during or post the procedure. All patients undergoing an endovascular procedure requiring an arteriotomy created by 12 to 20 F sheaths, via the common femoral artery will be screened against the inclusion/exclusion criteria. If the patient meets the requirements of the clinical investigation, they shall be invited to participate, provide informed consent and shall subsequently be assigned a subject number.
All subjects shall have an immediately post procedure, \~24 hour, 1 and 3 month follow-up assessment. Safety data from the follow-ups will be assessed by the Data Safety Monitoring Committee on a continuous basis.
Study Oversight
Has Oversight DMC:
True
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?: