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Open and Endovascular Surgical Treatment for Artery Injuries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03872323
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Li Min, Jinan Military General Hospital

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.

Condition or disease Intervention/treatment Phase
Artery Injury Procedure: Endovascular treatment Procedure: Open surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between Open and Endovascular Surgical Techniques to Manage Vascular Injuries
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : January 1, 2026

Arm Intervention/treatment
Active Comparator: Endovascular treatment Procedure: Endovascular treatment
The arteries injuries are repaired by endovascular treatment.

Active Comparator: Open surgery Procedure: Open surgery
The arteries injuries are repaired by open surgical operation.




Primary Outcome Measures :
  1. 5-year treatment success rate [ Time Frame: 60 months ]
    Treatment success is defined as restored blood flow without clinical complications.


Secondary Outcome Measures :
  1. Technically success rate of surgery [ Time Frame: immediately after surgery ]
  2. Surgery-related complications or death [ Time Frame: 60 months ]
  3. Currence of stenosis of target lesion [ Time Frame: 60 months ]
  4. Device-related serious adverse events [ Time Frame: 60 months ]
  5. Target lesion was treated by interventional or surgical therapy once again [ Time Frame: 60 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872323


Contacts
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Contact: Min Li, M.D. 13953176057 liminyingxiang@163.com

Locations
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China, Shandong
960 Hospital of PLA Recruiting
Jinan, Shandong, China, 250031
Contact: Min Li, M.D.         
Sponsors and Collaborators
Jinan Military General Hospital

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Responsible Party: Li Min, Vice Director, Jinan Military General Hospital
ClinicalTrials.gov Identifier: NCT03872323    
Other Study ID Numbers: 960HP20190045
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Li Min, Jinan Military General Hospital:
Artery Injury
Surgery
Endovascular Repair
Peripheral Arteries
Additional relevant MeSH terms:
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Wounds and Injuries