Application of Vascular Closure Device in Transvenous Cardiac Intervention

Vascular Access Complications Clinical Trial

Official title:

Comparison of Safety and Efficacy Between the Application of Vascular Closure Device and Conventional Figure-of-eight Suture in Transvenous Cardiac Interventional Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05521100
• Other study ID #: NSH-ACT
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 30, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: September 2022
• Source: Shanghai 10th People's Hospital
• Contact: DONGDONG ZHAO, M.D.
• Phone: +86 15000420881
• Email: zhaodd[@]tongji.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of safety and efficacy between the application of vascular closure device and conventional figure-of-eight suture in transvenous cardiac interventional surgery

Description:

Comparison of safety and efficacy between the application of vascular closure device and conventional figure-of-eight suture in transvenous cardiac interventional surgery.From the operation success rate, postoperative bleeding, immobilization time, the rate of revisiting the doctor due to wound problems within 1 month, etc.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: December 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients receiving lower extremity venous intervention with a diameter of 12F or more

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Vascular Access Complications

Intervention

Procedure:
• Vascular closure device
Suture of lower extremity veins using the Proglide Vascular Closure Device
• figure eight stitch
Vascular Sutures for Transvenous Cardiac Intervention Using Conventional Figure-8 Sutures

Locations

Country	Name	City	State
China	Jun Zhang	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular bleeding event rate	Proportion of bleeding after two methods of vascular suturing	1month
Secondary	bed braking time	Postoperative bed rest time	1 day