Application of Vascular Closure Device in Transvenous Car... | NCT05521100

Studies
Application of Vascular Closure Device in Transvenous Cardiac Intervention

NCT05521100

Sponsor

Shanghai 10th People's Hospital

Status

Unknown status

Last Update Posted

Sep 27, 2022Actual

Enrollment

160Estimated

Phase

Not Applicable

Conditions

Vascular Access Complications

Interventions

Vascular closure device
figure eight stitch

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 30, 2022Estimated

Primary Completion Date

Aug 1, 2023Estimated

Completion Date

Dec 1, 2023Estimated

First Submitted Date

Aug 29, 2022

First Submission Date that Met QC Criteria

Aug 29, 2022

First Posted Date

Aug 30, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2022

Last Update Posted Date

Sep 27, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ya-Wei Xu, Director of Cardiology, Shanghai 10th People's HospitalPrincipal Investigator

Lead Sponsor

Shanghai 10th People's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Vascular closure device	Procedure	Suture of lower extremity veins using the Proglide Vascular Closure Device	Proglide group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
DONGDONG ZHAO, M.D.	Contact	+86 15000420881		zhaodd@tongji.edu.cn
Jun Zhang, M.D.	Contact	+8615000420881		zhangjun_njmu2011@163.com

Overall Officials

Name	Affiliation	Role
Yawei Xu, PhD	Tongji University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jun Zhang		Shanghai	Shanghai Municipality	200072	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D065506	Vascular Closure Devices

Ancestor Terms

ID	Term
D053831	Surgical Fixation Devices
D013523	Surgical Equipment
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided