Application of Vascular Closure Device in Transvenous Cardiac Intervention

September 25, 2022 updated by: Ya-Wei Xu, Shanghai 10th People's Hospital

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200072
        • Jun Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Proglide group
Vascular Sutures for Transvenous Cardiac Interventions Using Proglide
Procedure: Vascular closure device
Suture of lower extremity veins using the Proglide Vascular Closure Device
ACTIVE_COMPARATOR: figure eight stitch
Vascular Sutures for Transvenous Cardiac Intervention Using Conventional Figure-8 Sutures
Procedure: figure eight stitch
Vascular Sutures for Transvenous Cardiac Intervention Using Conventional Figure-8 Sutures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vascular bleeding event rate
Time Frame: 1month
Proportion of bleeding after two methods of vascular suturing
1month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bed braking time
Time Frame: 1 day
Postoperative bed rest time
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 10th People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 30, 2022

Primary Completion (ANTICIPATED)

August 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

August 29, 2022

First Submitted That Met QC Criteria

August 29, 2022

First Posted (ACTUAL)

August 30, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 25, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • NSH-ACT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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