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Open and Endovascular Surgical Treatment for Artery Injuries

Primary Purpose

Artery Injury

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Endovascular treatment

Open surgery

About this trial

This is an interventional treatment trial for Artery Injury focused on measuring Artery Injury, Surgery, Endovascular Repair, Peripheral Arteries

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

960 Hospital of PLARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Endovascular treatment

Open surgery

Arm Description

Outcomes

Primary Outcome Measures

5-year treatment success rate

Treatment success is defined as restored blood flow without clinical complications.

Secondary Outcome Measures

Technically success rate of surgery

Surgery-related complications or death

Currence of stenosis of target lesion

Device-related serious adverse events

Target lesion was treated by interventional or surgical therapy once again

Full Information

NCT ID

NCT03872323

First Posted

March 11, 2019

Last Updated

March 11, 2019

Sponsor

Jinan Military General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03872323

Brief Title

Open and Endovascular Surgical Treatment for Artery Injuries

Official Title

Comparison Between Open and Endovascular Surgical Techniques to Manage Vascular Injuries

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2019 (Anticipated)

Primary Completion Date

April 30, 2024 (Anticipated)

Study Completion Date

January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Jinan Military General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Artery Injury

Keywords

Artery Injury, Surgery, Endovascular Repair, Peripheral Arteries

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Non-Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Endovascular treatment

Arm Type

Active Comparator

Arm Title

Open surgery

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Endovascular treatment

Intervention Description

The arteries injuries are repaired by endovascular treatment.

Intervention Type

Procedure

Intervention Name(s)

Open surgery

Intervention Description

The arteries injuries are repaired by open surgical operation.

Primary Outcome Measure Information:

Title

5-year treatment success rate

Description

Treatment success is defined as restored blood flow without clinical complications.

Time Frame

60 months

Secondary Outcome Measure Information:

Title

Technically success rate of surgery

Time Frame

immediately after surgery

Title

Surgery-related complications or death

Time Frame

60 months

Title

Currence of stenosis of target lesion

Time Frame

60 months

Title

Device-related serious adverse events

Time Frame

60 months

Title

Target lesion was treated by interventional or surgical therapy once again

Time Frame

60 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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. -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Min Li, M.D.

Phone

13953176057

liminyingxiang@163.com

Facility Information:

Facility Name

960 Hospital of PLA

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250031

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Min Li, M.D.

12. IPD Sharing Statement

Learn more about this trial

Open and Endovascular Surgical Treatment for Artery Injuries

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