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Clinical Trials/NCT05521100
NCT05521100UnknownNot Applicable

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

Shanghai 10th People's Hospital1 site in 1 country160 target enrollmentStarted: September 30, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
160
Locations
1
Primary Endpoint
Vascular bleeding event rate

Study Overview

Brief Summary

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

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Vascular bleeding event rate

Time Frame: 1month

Proportion of bleeding after two methods of vascular suturing

Secondary Outcomes

  • bed braking time(1 day)

Investigators

Sponsor
Shanghai 10th People's Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ya-Wei Xu

Director of Cardiology

Shanghai 10th People's Hospital

Study Sites (1)

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