NCT05521100

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 30, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

10 months

First QC Date

August 29, 2022

Last Update Submit

September 25, 2022

Conditions

Vascular Access Complications

Outcome Measures

Primary Outcomes (1)

  • Vascular bleeding event rate

    Proportion of bleeding after two methods of vascular suturing

    1month

Secondary Outcomes (1)

  • bed braking time

    1 day

Study Arms (2)

Proglide group

EXPERIMENTAL

Vascular Sutures for Transvenous Cardiac Interventions Using Proglide

Procedure: Vascular closure device

figure eight stitch

ACTIVE COMPARATOR

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

Procedure: figure eight stitch

Interventions

Vascular closure devicePROCEDURE

Suture of lower extremity veins using the Proglide Vascular Closure Device

Proglide group
figure eight stitchPROCEDURE

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

figure eight stitch

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jun Zhang

Shanghai, Shanghai Municipality, 200072, China

Location

MeSH Terms

Interventions

Vascular Closure Devices

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Yawei Xu, PhD

    Tongji University

    STUDY CHAIR

Central Study Contacts

DONGDONG ZHAO, M.D.

CONTACT

+86 15000420881zhaodd@tongji.edu.cn

Jun Zhang, M.D.

CONTACT

+8615000420881zhangjun_njmu2011@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cardiology

Study Record Dates

First Submitted

August 29, 2022

First Posted

August 30, 2022

Study Start

September 30, 2022

Primary Completion

August 1, 2023

Study Completion

December 1, 2023

Last Updated

September 27, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)