Ignite Creation Date:
2024-05-06 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05163548
Status:
COMPLETED
Last Update Posted:
2023-04-26
First Post:
2021-12-06
Brief Title:
PerQseal Early Feasibility Study
Sponsor:
Vivasure Medical Limited
Organization:
Vivasure Medical Limited
Study Overview
Official Title:
Early Feasibility Study of the Vivasure PerQseal PerQseal Plus Vascular Closure Device When Used to Achieve Hemostasis of Common Femoral Arteriotomies Created by 14 to 22 F Sheaths in Patients Undergoing Percutaneous Transcatheter Procedures
Status:
COMPLETED
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 objective of this Early Feasibility Study EFS is to evaluate the initial safety and preliminary effectiveness of the PerQseal VCD in a small number of subjects when used to achieve hemostasis of common femoral arteriotomies created by 14 to 22 F sheaths arteriotomy up to 26 F in subjects undergoing Percutaneous Transcatheter procedures
Detailed Description:
This study is a prospective multi-center single arm EFS Patients undergoing a percutaneous trancatheter procedure requiring an arteriotomy created by 14 - 22 F sheaths arteriotomies up to approx 26 F via the common femoral artery will be screened against the study inclusionexclusion criteria If the patient meets study eligibility requirements they shall be invited to participate provide informed consent and shall subsequently be assigned a study ID number Enrollment will occur at the point where the PerQseal VCD study device first enters the patients body
The planned enrollment is 15 treated patients at a maximum of 5 study sites minimum of 3 located in the United States
The planned enrollment is 15 treated patients at a maximum of 5 study sites minimum of 3 located in the United States
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None