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Triple-branch Stent Graft Placement and Total-arch Replacement for the Treatment of Acute DeBakey I Aortic Dissection

NCT02622750 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2017-11-17

No results posted yet for this study

Summary

The purpose of this study is to compare triple-branched stent placement with total-arch replacement in the treatment of acute DeBakey I aortic dissection . The investigators design optimal effect compare prospective, multi-center, randomized, open-label, parallel-group, non-inferiority clinical trial.

Conditions

  • Acute Aortic Dissection

Interventions

PROCEDURE

triple-branched stent graft

place the triple-branched stent graft into the aortic arch, descending aorta ,the left subclavian artery, the left common carotid artery, and the innominate artery.

PROCEDURE

four-branched Dacron graft

The stent elephant trunk was inserted into the true lumen of the distal aorta in a bound, compressed state after the distal aorta was transected between the origin of the left subclavian artery and the left carotid artery. The distal aorta incorporating the stent graft was firmly attached to the distal end of the four-branched Dacron graft using the "open" aortic procedure. After the anastomosis was completed, blood perfusion of the lower body was started via the perfusion limb of the four-branched Dacron graft.

Sponsors & Collaborators

  • Xinqiao Hospital of Chongqing

    collaborator OTHER

  • RenJi Hospital

    collaborator OTHER

  • First Affiliated Hospital of Zhongshan Medical University

    collaborator OTHER

  • Longyan City First Hospital

    collaborator OTHER

  • The First City Hospital, ZhanZhou

    collaborator UNKNOWN

  • Liang-Wan Chen MD

    lead OTHER

Principal Investigators

  • Liang-Wan Chen, M.D PH · the director of the department of cardiovascular surgery Union Hospital FuJian Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-01
Primary Completion
2018-11-30
Completion
2019-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02622750 on ClinicalTrials.gov