Triple-branch Stent Graft Placement for the Treatment of Acute DeBakey I Aortic Dissection

NCT02732340 | Completed DMC

• 1 other identifier: CLW2015AD
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate triple-branched stent placement in the treatment of acute DeBakey I aortic dissection . The investigators design a prospective, single-center, open-label, non-controlled clinical trial.

Conditions

Acute Aortic Dissection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• the occluded rate of false lumen by CTA

  one year postoperatively

Secondary Outcomes (5)

• the survive rate by the questionaire

  3 months, 6 months, 12 months postoperatively

• complication by the case report

  1 months postoperatively

• reoperation rate by the case report

  1 year postoperatively

• the growth rate of thoracic descending aorta by CTA

  3 months, 6 months, 12 months postoperatively

• life quality by the questionaire

  3 months, 6 months, 12 months postoperatively

Study Arms (1)

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

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

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 DeBakey I aortic dissection is confirmed by CTA; cardiac function is NYHA(New York Heart Association) 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

• Fujian Medical University: lead

Study Sites (1)

the Department of Cardiovascular Surgery

Fuzhou, Fujian, 350001, China

Location

Related Publications (20)

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• Chen LW, Dai XF, Lu L, Zhang GC, Cao H. Extensive primary repair of the thoracic aorta in acute type a aortic dissection by means of ascending aorta replacement combined with open placement of triple-branched stent graft: early results. Circulation. 2010 Oct 5;122(14):1373-8. doi: 10.1161/CIRCULATIONAHA.110.946012. Epub 2010 Sep 20.

  PMID: 20855660 RESULT

• Chen LW, Wu XJ, Lu L, Zhang GC, Yang GF, Yang ZW, Dong Y, Cao H, Chen Q. Total arch repair for acute type A aortic dissection with 2 modified techniques: open single-branched stent graft placement and reinforcement of the dissected arch vessel stump with stent graft. Circulation. 2011 Jun 7;123(22):2536-41. doi: 10.1161/CIRCULATIONAHA.110.008656. Epub 2011 May 16.

  PMID: 21576657 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The director of the department of cardiovascular surgery

Study Record Dates

• First Submitted: November 15, 2015
• First Posted: April 8, 2016
• Study Start: October 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2018
• Last Updated: November 20, 2018

Record last verified: 2018-11

Locations

CN (1)