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Acute Aortic DissectionEarly Phase 1TBSGPATARTNCT02622750

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

A Early Phase 1 study testing triple-branched stent graft and four-branched Dacron graft in people with Acute Aortic Dissection, run by Liang-Wan Chen MD at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Acute Aortic Dissection
What is being tested?
triple-branched stent graft and four-branched Dacron graft
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
1 Nov 2016to 31 Mar 2019
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Liang-Wan Chen, M.D PH.D contact

86 13358255333

daixiaofu719@hotmail.com

China1 site, 1 recruiting
  • the Department of Cardiovascular Surgery

    Fuzhou, Fujian, 350001

    Liang-Wan Chen, M.D Ph.D, 86 13358255333, daixiaofu719@hotmail.com

    E Lin, M.D, 86 13365912195, 1470054258@qq.com

    Recruiting

Other trials in China

About this study

Official title: Triple-branch Stent Graft Placement and Total-arch Replacement for the Treatment of Acute DeBakey I Aortic Dissection: A Prospective, Multi-center, Randomized, Open-label, Parallel-group, Non-inferiority Clinical Trial

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.

Read the detailed description

From November 2015, 90 consecutive patients with acute DeBakey I aortic dissection from five-centers in China were treated with triple-branched stent placement or hemi-arch replacement. The distribution of the patients adopts the dynamic random variance minimization random method. About half of the patients will be assigned to the the stent-graft group, the other to the hemi-arch group.

In all cases, surgery was performed under general anesthesia with tracheal intubation and cardiopulmonary bypass (CPB). During surgery arterial pressures at the upper and lower limbs were monitored. An esophageal echocardiography probe was placed routinely, and a sternal incision was performed. To establish CPB, the perfusion tube was placed in the right axillary artery and the drainage tube was placed in the superior and inferior vena cava through the right atrium. The CPB flow rate was of 2.4-2.6 L/kg/min. Intermittent cold blood cardioplegia was perfused through the left and right coronary arteries for myocardial protection.

In stent-graft group , the innominate artery and the left common carotid artery were fully isolated during the CPB cooling process. The ascending aorta proximal to the innominate artery was occluded, and the ascending aorta was transected slightly above the sinus tube connection; the left and right coronary arteries were directly perfused with blood-containing cold cardioplegia. Proximal procedures such as aortic valve repair, sinus reconstruction, and root replacement were performed first. Afterwards, the stumps were reconstructed. The reconstructed aortic root stump was anastomosed with a Dacron graft of corresponding size using 4-0 polypropylene suture (ascending aorta replacement). The nasopharyngeal temperature was then decreased to 25° (usually a rectal temperature of 27-29°C), the aortic perfusion flow was set to 10-15 ml/kg/min, and the innominate artery and the left common carotid artery were occluded 5-6 cm above the aortic arch. The aortic occlusion clamp was removed and a half aortic arch transection was made about 2 cm proximal to the innominate artery. Through the incision, the true lumens of the aortic arch, the proximal descending aorta, and the three aortic branches were identified. The triple-branched stent graft was inserted into the true lumens of the aortic arch and proximal descending aorta; the three stent graft branches were then placed 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. A catheter with a balloon or a probe was used to expand the vascular stents and the graft and branches were examined for kinks or folding of the backbone. A sandwich reconstruction was performed between the aortic stump, the aortic external Dacron graft, and the proximal stentless suture zone of the intraluminal artificial vessel backbone. The reconstructed stump was anastomosed with the Dacron graft that replaced the ascending aorta using 4-0 polypropylene suture. The occlusions of the left common carotid artery and the innominate artery were then relieved, and air was fully flushed out from the heart and the aorta. The right axillary artery perfusion was stopped, and systemic perfusion via an aortic perfusion tube at the artificial portion of the ascending aorta was performed. The patient was rewarmed after oxygen debt repayment, followed by the cardiac resuscitation.

In total-arch group , the ascending aorta proximal to the innominate artery was blocked during the CPB cooling process, and the ascending aorta was incised and transected slightly above the sinus tube connection. The left and right coronary arteries were directly perfused with blood-containing cold cardioplegia. As in stent-graft group , proximal procedures were performed first. The reconstructed aortic root stumps were sutured with Dacron graft using 4-0 polypropylene suture (ascending aorta replacement). The nasopharyngeal temperature was then decreased to 25° (usually a rectal temperature of 27-29°C) and the aortic perfusion flow was set to 10-15 ml/kg/min. The innominate artery and the left common carotid artery were clamped 5-6 cm above the aortic arch and the aortic occlusion clamp was removed. Half aortic arch resection was performed along the greater curvature of the aortic arch at 1 cm proximal of the innominate artery to the lesser curvature of the aortic arch at the origin of the descending aorta. Stumps between the dissection slices were lined with cotta slices and reconstructed using the sandwich method and then anastomosed with an Dacron graft of the corresponding size and shape using 4-0 polypropylene suture. Finally, the proximal end was anastomosed with the artificial blood vessel using 4-0 polypropylene suture. Air was fully flushed from the heart and aorta. The right auxiliary artery perfusion was stopped and systemic perfusion via an aortic perfusion tube at the artificial blood vessel of the ascending aorta was performed. The patient was rewarmed after oxygen debt repayment, followed by cardiac resuscitation.

Telephone contact was maintained with the patients after discharge. At 3,6,12 months postoperatively , patients received a follow-up examination, chest radiography, echocardiography, bilateral carotid artery Doppler examinations and CT angiography (CTA) examinations Numerical data were expressed as percentages, and comparisons between groups were performed with the chi-square test. Quantitative data were expressed as mean ± standard deviation; the independent sample t test was used for group comparisons and the paired t-test was used to compare the groups before and after surgery. The primary end point is the occluded rate of the false lumen one year postoperatively. The secondary end point are the survive rate ,complication, reoperation rate, the growth rate of thoracic descending aorta, security index perioperatively, life quality postoperatively.Statistical analysis were performed with SPSS 11.5 software. A value of P < 0.05 was considered statistically significant.

Being tested
triple-branched stent graft, four-branched Dacron graft
Keywords
triple-branched stent graft, total arch replace, the occluded rate of false lumen

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • triple-branched stent graftProcedure or surgery

    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.

  • four-branched Dacron graftProcedure or surgery

    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.

Study groups in NCT02622750
Study groupRoleWhat they receive
triple-branched stent graftExperimentalThe 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.
Receives: Procedure: triple-branched stent graft
four-branched Dacron graftActive comparatorA 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.
Receives: Procedure: four-branched Dacron graft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the occluded rate of false lumen by the CTA

    Measured: 1 year postoperatively

Secondary outcomes (6)
  1. the survive rate by the questionnaire

    Measured: 3 months, 6 months, 12 months postoperatively

  2. complication by the datum of case

    Measured: 1 months postoperatively

  3. reoperation rate by the datum of case

    Measured: 1 year postoperatively

  4. the growth rate of thoracic descending aorta by the CTA

    Measured: 3 months, 6 months, 12 months postoperatively

  5. security index by the datum of case

    Measured: 7 days perioperatively

  6. life quality by the questionnaire

    Measured: 3 months, 6 months, 12 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2015 (estimated)
  2. Study start1 Nov 2016
  3. Primary completion30 Nov 2018 (estimated)
  4. Study completion31 Mar 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02622750
Sponsor's protocol ID
CLW2015AD2
Acronym
TBSGPATART
Status last verified
Dec 2015
First submitted
19 Nov 2015
Last updated
17 Nov 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20855660
  • 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.

    PubMed 21576657
  • Sun L, Qi R, Chang Q, Zhu J, Liu Y, Yu C, Zhang H, Lv B, Zheng J, Tian L, Lu J. Surgery for marfan patients with acute type a dissection using a stented elephant trunk procedure. Ann Thorac Surg. 2008 Dec;86(6):1821-5. doi: 10.1016/j.athoracsur.2008.08.026.

    PubMed 19021985
  • Sun L, Qi R, Chang Q, Zhu J, Liu Y, Yu C, Zhang H, Lv B, Zheng J, Tian L, Lu J. Surgery for acute type A dissection with the tear in the descending aorta using a stented elephant trunk procedure. Ann Thorac Surg. 2009 Apr;87(4):1177-80. doi: 10.1016/j.athoracsur.2009.01.042.

    PubMed 19324146
  • Liu ZG, Sun LZ, Chang Q, Zhu JM, Dong C, Yu CT, Liu YM, Zhang HT. Should the "elephant trunk" be skeletonized? Total arch replacement combined with stented elephant trunk implantation for Stanford type A aortic dissection. J Thorac Cardiovasc Surg. 2006 Jan;131(1):107-13. doi: 10.1016/j.jtcvs.2005.09.015. Epub 2005 Dec 9.

    PubMed 16399301
  • Estrera AL, Miller CC 3rd, Huynh TT, Porat E, Safi HJ. Neurologic outcome after thoracic and thoracoabdominal aortic aneurysm repair. Ann Thorac Surg. 2001 Oct;72(4):1225-30; discussion 1230-1. doi: 10.1016/s0003-4975(01)02971-x.

    PubMed 11603441
  • Chiappini B, Schepens M, Tan E, Dell' Amore A, Morshuis W, Dossche K, Bergonzini M, Camurri N, Reggiani LB, Marinelli G, Di Bartolomeo R. Early and late outcomes of acute type A aortic dissection: analysis of risk factors in 487 consecutive patients. Eur Heart J. 2005 Jan;26(2):180-6. doi: 10.1093/eurheartj/ehi024. Epub 2004 Dec 7.

    PubMed 15618075
  • Trimarchi S, Nienaber CA, Rampoldi V, Myrmel T, Suzuki T, Mehta RH, Bossone E, Cooper JV, Smith DE, Menicanti L, Frigiola A, Oh JK, Deeb MG, Isselbacher EM, Eagle KA; International Registry of Acute Aortic Dissection Investigators. Contemporary results of surgery in acute type A aortic dissection: The International Registry of Acute Aortic Dissection experience. J Thorac Cardiovasc Surg. 2005 Jan;129(1):112-22. doi: 10.1016/j.jtcvs.2004.09.005.

    PubMed 15632832
  • Rampoldi V, Trimarchi S, Eagle KA, Nienaber CA, Oh JK, Bossone E, Myrmel T, Sangiorgi GM, De Vincentiis C, Cooper JV, Fang J, Smith D, Tsai T, Raghupathy A, Fattori R, Sechtem U, Deeb MG, Sundt TM 3rd, Isselbacher EM; International Registry of Acute Aortic Dissection (IRAD) Investigators. Simple risk models to predict surgical mortality in acute type A aortic dissection: the International Registry of Acute Aortic Dissection score. Ann Thorac Surg. 2007 Jan;83(1):55-61. doi: 10.1016/j.athoracsur.2006.08.007.

    PubMed 17184630
  • Crawford ES, Kirklin JW, Naftel DC, Svensson LG, Coselli JS, Safi HJ. Surgery for acute dissection of ascending aorta. Should the arch be included? J Thorac Cardiovasc Surg. 1992 Jul;104(1):46-59.

    PubMed 1614214
  • Hirotani T, Nakamichi T, Munakata M, Takeuchi S. Routine extended graft replacement for an acute type A aortic dissection and the patency of the residual false channel. Ann Thorac Surg. 2003 Dec;76(6):1957-61. doi: 10.1016/s0003-4975(03)01325-0.

    PubMed 14667621
  • Takahara Y, Sudo Y, Mogi K, Nakayama M, Sakurai M. Total aortic arch grafting for acute type A dissection: analysis of residual false lumen. Ann Thorac Surg. 2002 Feb;73(2):450-4. doi: 10.1016/s0003-4975(01)03422-1.

    PubMed 11845858
  • Urbanski PP, Siebel A, Zacher M, Hacker RW. Is extended aortic replacement in acute type A dissection justifiable? Ann Thorac Surg. 2003 Feb;75(2):525-9. doi: 10.1016/s0003-4975(02)04378-3.

    PubMed 12607666
  • Khan IA, Nair CK. Clinical, diagnostic, and management perspectives of aortic dissection. Chest. 2002 Jul;122(1):311-28. doi: 10.1378/chest.122.1.311.

    PubMed 12114376
  • Pochettino A, Brinkman WT, Moeller P, Szeto WY, Moser W, Cornelius K, Bowen FW, Woo YJ, Bavaria JE. Antegrade thoracic stent grafting during repair of acute DeBakey I dissection prevents development of thoracoabdominal aortic aneurysms. Ann Thorac Surg. 2009 Aug;88(2):482-9; discussion 489-90. doi: 10.1016/j.athoracsur.2009.04.046.

    PubMed 19632398

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing triple-branched stent graft and four-branched Dacron graft in people with Acute Aortic Dissection, run by Liang-Wan Chen MD at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Liang-Wan Chen, M.D PH.D (86 13358255333, daixiaofu719@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the occluded rate of false lumen by the CTA (time frame: 1 year postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02622750, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.

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