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

NCT02622750 | Unknown Early Phase 1 DMC

• 1 other identifier: CLW2015AD2
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

triple-branched stent graft; total arch replace; the occluded rate of false lumen

Outcome Measures

Primary Outcomes (1)

• the occluded rate of false lumen by the CTA

  1 year postoperatively

Secondary Outcomes (6)

• the survive rate by the questionnaire

  3 months, 6 months, 12 months postoperatively

• complication by the datum of case

  1 months postoperatively

• reoperation rate by the datum of case

  1 year postoperatively

• the growth rate of thoracic descending aorta by the CTA

  3 months, 6 months, 12 months postoperatively

• security index by the datum of case

  7 days perioperatively

Study Arms (2)

triple-branched stent graft

EXPERIMENTAL

The triple-branched stent graft was a branched 1-piece graft and included a main stent graft and 3 sidearm stent grafts (Yuhengjia Science and Technology, Corp, Ltd, Beijing, China). The main stent graft and sidearm stent grafts were individually mounted on 4 catheters and restrained by 4 silk sutures .The triple-branched stent graft was inserted into the true lumens of the aortic arch and proximal descending aorta; the three vascular stent branches were then grafted into the corresponding true lumens of the aortic arch branch vessels followed by the sequential release of the vascular stent backbone and the branch stents in the left subclavian artery, the left common carotid artery, and the innominate artery.

Procedure: triple-branched stent graft

four-branched Dacron graft

ACTIVE COMPARATOR

A four-branched Dacron graft (Boston Scientific Inc, Boston, MA) and a stent graft (MicroPort Medical Co Ltd, Shanghai, China) were used in total arch replacement combined with stented elephant trunk (SET) implantation.The SET was inserted into the true lumen of the descending aorta.The proximal edge of the residual aorta was trimmed to match the proximal end of the stent graft.The anastomosis between the four-branched prosthetic graft and the distal aorta containing the intraluminal stented graft was carried out using "open" aortic technique.

Procedure: four-branched Dacron graft

Interventions

triple-branched stent graft PROCEDURE

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.

triple-branched stent graft

four-branched Dacron graft PROCEDURE

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.

four-branched Dacron graft

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age\<65 years
• acute DeBakkey I aortic dissection is confirmed by CTA
• cardiac function is NYHA I-II
• the onset time\< 2 weeks
• the patient or family members can understand the research plan and will participate in this study and provide a written informed consent

You may not qualify if:

• Dissection involved the superior mesenteric artery, renal artery and coronary artery, which affect the body's viscera function seriously. The principal researcher from different centre need judge the patients' condition.
• there is a serious complication of nervous system, such as coma, paraplegia, etc
• pregnant or lactating women
• anyone with severe emphysema, interstitial pneumonia or ischemic heart disease cannot tolerate surgery
• subjects with contraindications of heart surgery, anesthesia and extracorporeal circulation
• subjects had significant or progressive of heart disease, according to the experience of the researchers,whose life expectancy is less than 1 year, or placement of triple- branched stent graft will induce unacceptable risk to the subjects
• anyone with serious mental illness, drug abuse, alcoholism, prison inmates, a lack of ability to care for, or can not express the informed consent
• subjects are incompliance or can't complete the research
• anyone is involved in the other clinical trial
• other reasons are not suitable for clinical trials, according to the researchers

Sponsors & Collaborators

• Liang-Wan Chen MD: lead
• Xinqiao Hospital of Chongqing: collaborator
• RenJi Hospital: collaborator
• First Affiliated Hospital of Zhongshan Medical University: collaborator
• Longyan City First Hospital: collaborator
• The First City Hospital, ZhanZhou: collaborator

Study Sites (1)

the Department of Cardiovascular Surgery

Fuzhou, Fujian, 350001, China

RECRUITING

Related Publications (24)

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Study Officials

• Liang-Wan Chen, M.D PH

  the director of the department of cardiovascular surgery Union Hospital FuJian Medical University

  STUDY DIRECTOR

Central Study Contacts

Liang-Wan Chen, M.D PH.D

CONTACT

86 13358255333; daixiaofu719@hotmail.com

E Lin, M.D

CONTACT

8613365912195; 1470054258@qq.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The director of the department of cardiovascular surgery

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: December 4, 2015
• Study Start: November 1, 2016
• Primary Completion: November 30, 2018
• Study Completion: March 31, 2019
• Last Updated: November 17, 2017

Record last verified: 2015-12

Locations

CN (1)