Application of Vascular Closure Device in Transvenous Cardiac Intervention

NCT ID: NCT05521100

Last Updated: 2022-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2023-12-01

Brief Summary

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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

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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.

Conditions

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Vascular Access Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Proglide group

Vascular Sutures for Transvenous Cardiac Interventions Using Proglide

Group Type EXPERIMENTAL

Vascular closure device

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

figure eight stitch

Intervention Type PROCEDURE

Vascular Sutures for Transvenous Cardiac Intervention Using Conventional Figure-8 Sutures

Interventions

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Vascular closure device

Suture of lower extremity veins using the Proglide Vascular Closure Device

Intervention Type PROCEDURE

figure eight stitch

Vascular Sutures for Transvenous Cardiac Intervention Using Conventional Figure-8 Sutures

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ya-Wei Xu

Director of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yawei Xu, PhD

Role: STUDY_CHAIR

Tongji University

Locations

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Jun Zhang

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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DONGDONG ZHAO, M.D.

Role: CONTACT

+86 15000420881

Jun Zhang, M.D.

Role: CONTACT

+8615000420881

Other Identifiers

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NSH-ACT

Identifier Type: -

Identifier Source: org_study_id

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