Open and Endovascular Surgical Treatment for Artery Injuries | NCT03872323

Studies
Open and Endovascular Surgical Treatment for Artery Injuries

NCT03872323

Sponsor

Jinan Military General Hospital

Status

Unknown status

Last Update Posted

Mar 13, 2019Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Artery Injury

Interventions

Endovascular treatment
Open surgery

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

Mar 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2019Estimated

Primary Completion Date

Apr 30, 2024Estimated

Completion Date

Jan 1, 2026Estimated

First Submitted Date

Mar 11, 2019

First Submission Date that Met QC Criteria

Mar 11, 2019

First Posted Date

Mar 13, 2019Actual

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

Mar 11, 2019

Last Update Posted Date

Mar 13, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Traumatic injuries of peripheral arteries are often associated with multiple injuries, massive hemorrhage, state of shock, and loss of blood supply, as well as with high mortality. Traditionally, an open surgical approach is suggested for the management of artery injury. With the advancement of endovascular techniques, the traditional open vascular exposure and vessel repair are no longer the only option available. The purpose of this study is to compare the effectiveness, long-term safety and explore the safety and efficacy factors between open and endovascular surgical techniques.

Detailed Description

Not provided

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endovascular treatment	Active Comparator		Procedure: Endovascular treatment
Open surgery	Active Comparator		Procedure: Open surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endovascular treatment	Procedure	The arteries injuries are repaired by endovascular treatment.	Endovascular treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
5-year treatment success rate	Treatment success is defined as restored blood flow without clinical complications.	60 months

Secondary Outcomes

Measure	Description	Time Frame
Technically success rate of surgery		immediately after surgery
Surgery-related complications or death		60 months
Currence of stenosis of target lesion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Injuries in the peripheral arteries; Loss of blood supply to the remote area; High-risk emergency artery reconstruction; Participate in the study voluntarily, accept follow up study. -

Exclusion Criteria:

Bleeding can be easily control; There is contraindications for surgical operation. -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Min Li, M.D.	Contact	13953176057		liminyingxiang@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
960 Hospital of PLA	Recruiting	Jinan	Shandong	250031	China

Intervention Browse Module

MeSH Terms

ID	Term
D061887	Conversion to Open Surgery

Ancestor Terms

ID	Term
D004724	Endoscopy
D019060	Minimally Invasive Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

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Browse Branches

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