Comparison of Figure-Of-Eight Suture Perclose ProGlide Suture-Mediated Closure

Venous Puncture Clinical Trial

Official title:

Comparison of Figure-Of-Eight Suture and Perclose ProGlide Suture-Mediated Closure System in Achieving Hemostasis After a Large Bore Venous Access.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04831008
• Other study ID #: 2020-149
• Status: Completed
• Phase: N/A
• Start date: August 6, 2020
• Est. completion date: December 13, 2022

Study information

• Verified date: January 2023
• Source: Delray Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study proposes to compare specialized closure devices to achieve hemostasis with the Figure-of-eight suture technique.

Description:

Procedures where patients requiring large bore venous access will be randomized 1:1 to either the Figure-of-eight suture technique or the Perclose Device to achieve hemostasis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 13, 2022
• Est. primary completion date: December 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• All patients who successfully undergo venous large bore access sheath placement for structural heart procedures.

Exclusion Criteria:

• Patients who do not consent

• Minors or those unable to consent

Related Conditions & MeSH terms

• Venous Puncture

Intervention

Other:
• Figure-of-eight suture
Using the figure-of-eight closure technique when closing access for structural heart therapies.
• Perclose Device
Using the Perclose device when closing access for structural heart therapies.

Locations

Country	Name	City	State
United States	Delray Medical Center	Delray Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Delray Medical Center	Florida Atlantic University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemostasis Time	To assess if an additional device use to achieve hemostasis can be avoided after a large bore venous access	Immediate
Primary	Procedure Time		Immediate
Primary	Access Site Complication		1 month