Study Comparing Hemiarch Replacement and Hemiarch Plus Stent Implantation in Acute Aortic Dissection

NCT06044259 | Recruiting DMC

• 1 other identifier: CRE ref: 2023.075-T
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Acute DeBakey type I aortic dissection (ATAD) is one of the most lethal surgical emergencies. The conventional operative strategy is hemiarch replacement under cardiopulmonary bypass support to replace the diseased segment of the ascending aorta. However, in patients with dissection involving the whole aortic arch and descending thoracic aorta, the presence of the persistently perfused false lumen can lead to late aneurysm formation and require a second-stage operation, and this reduces long-term survival. In the surgical literature, there is growing evidence that the presence of Distal Anastomosis New Entry (DANE), which is a new intimal defect related to the trauma created by surgical sutures, is associated with persistent perfusion of the false lumen, aortic size growth, and the need of re-operation. The Ascyrus Medical Dissection Stent (AMDS; Artivion, Atlanta, Georgia, USA) is a hybrid prosthesis with a proximal sewing collar and distal nitinol self-expanding un-covered stent system designed to reduce the occurrence of DANE and hopefully depressurize the false lumen and lead to remodeling of the aortic wall. The investigators plan to prospectively recruit consecutive patients with acute ascending thoracic aortic dissection patients (Excluding DeBakey II) and randomized them, after informed consent, into either the conventional hemiarch replacement group (Hemiarch-C) or the hemiarch replacement plus AMDS implantation group (Hemiarch-AMDS). The participating team will collect pre-operative, intra-operative and post-operative clinical and radiological parameters for two groups of patients. Written informed consent, specifically allowing the use of clinical records for this randomized study, will be obtained from every patient prior to data collection. Complete DICOM image files of the CT scans will be evaluated by two independent fully qualified Radiologists. Our primary outcome is the radiological detection of DANE in Hemiarch-C and Hemiarch-AMDS groups within the 12-month follow-up period. This study will be the world's first randomized control trial in ATAD to compare the prevalence of DANE in Hemiarch-C and Hemiarch-AMDS. It could be a guideline-changing study for the treatment of ATAD and its impact on the immediate survival, second-stage treatment, and long-term survival of patients suffering from ATAD.

Conditions

Aortic Dissection

Keywords

Hemiarch replacement; AMDS implantation

Outcome Measures

Primary Outcomes (1)

• Incidence of DANE

  The presence of Distal Anastomosis New Entry (DANE) diagnosed by Computed Tomography in post-operative imaging within the 12-month follow-up period

  At Discharge(0-14days), 30-day, 3-6 month, 12 month

Secondary Outcomes (8)

• All-cause mortality of the patients

  At discharge(0-14days), 30-day, 3-6 month, 12 month

• Percentage of patient with aortic-related mortality

  At Discharge(0-14days), 30-day, 3-6 month, 12 month

• Percentage of patients with Major Adverse Events

  At Discharge(0-14days), 30-day, 3-6 month, 12 month

• Percentage of patients requiring additional aortic intervention

  At Discharge(0-14days), 30-day, 3-6 month, 12 month

• Percentage of patients with Renal failure

  At Discharge(0-14days), 30-day, 3-6 month, 12 month

Study Arms (2)

Hemiarch-AMDS

ACTIVE COMPARATOR

Patient with acute DeBakey I aortic dissection will be put on GA and conventional CPB. During circulatory arrest, the aorta will be trimmed to the level of the distal ascending or proximal arch The AMDS device will be implanted into the aortic arch and descending thoracic aorta. The distal anastomosis will be done between a vascular graft and the distal ascending aorta/aortic arch including the AMDS device sewing cuff. After the distal anastomosis is completed, visceral and cerebral systemic perfusion and rewarming will be started. Proximal anastomosis will be performed and the patient will be weaned from cardiopulmonary bypass and decannulated.

Procedure: AMDS; Artivion, Atlanta, Georgia, US

Hemiarch-C

ACTIVE COMPARATOR

Patient with acute DeBakey I aortic dissection will be put on GA and conventional CPB. During circulatory arrest, the aorta will be trimmed to the level of the distal ascending or proximal arch The AMDS device will be implanted into the aortic arch and descending thoracic aorta. The distal anastomosis will be done between a vascular graft and the distal ascending aorta/aortic arch as per routine. After the distal anastomosis is completed, visceral and cerebral systemic perfusion and rewarming will be started. Proximal anastomosis will be performed and the patient will be weaned from cardiopulmonary bypass and decannulated.

Procedure: Conventional hemiarch replacement

Interventions

AMDS; Artivion, Atlanta, Georgia, US PROCEDURE

Ascyrus Medical Dissection Stent (AMDS; Artivion, Atlanta, Georgia, US) hybrid prosthesis which comprises a proximal sewing collar and a distal self-expanding nitinol un-covered stent.

Hemiarch-AMDS

Conventional hemiarch replacement PROCEDURE

Coventional open hemiarch replacement

Hemiarch-C

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient´s age is between 18 and 80 years.
• Patient is willing and able to give informed consent.
• Patient has acute DeBakey Type I and requires repair or replacement of damaged or diseased vessels of the ascending aorta.
• Patient not in coma/irreversible end organ failure/cardiac massage for resuscitation, at the time of consent.

You may not qualify if:

• Patient has aortic arch diameter of more than 4.5 cm
• Patient has known connective tissue disease or genetically linked aortopathy
• Patient has entry tear more than 2 cm over aortic arch
• Patient with DeBakey Type II aortic dissection
• Patient has co-morbidity (i.e. active malignancy (progressive, stable or partial remission)) causing expected survival to be less than 2 years.
• Patient has any other medical, social, or psychological problems, that in the opinion of the investigator, preclude the patient from participating in this study.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong, 000, China

RECRUITING

Related Publications (21)

• Hagan PG, Nienaber CA, Isselbacher EM, Bruckman D, Karavite DJ, Russman PL, Evangelista A, Fattori R, Suzuki T, Oh JK, Moore AG, Malouf JF, Pape LA, Gaca C, Sechtem U, Lenferink S, Deutsch HJ, Diedrichs H, Marcos y Robles J, Llovet A, Gilon D, Das SK, Armstrong WF, Deeb GM, Eagle KA. The International Registry of Acute Aortic Dissection (IRAD): new insights into an old disease. JAMA. 2000 Feb 16;283(7):897-903. doi: 10.1001/jama.283.7.897.

  PMID: 10685714 BACKGROUND

• Czerny M, Schoenhoff F, Etz C, Englberger L, Khaladj N, Zierer A, Weigang E, Hoffmann I, Blettner M, Carrel TP. The Impact of Pre-Operative Malperfusion on Outcome in Acute Type A Aortic Dissection: Results From the GERAADA Registry. J Am Coll Cardiol. 2015 Jun 23;65(24):2628-2635. doi: 10.1016/j.jacc.2015.04.030.

  PMID: 26088302 BACKGROUND

• Bozso SJ, Nagendran J, Chu MWA, Kiaii B, El-Hamamsy I, Ouzounian M, Kempfert J, Starck C, Moon MC. Midterm Outcomes of the Dissected Aorta Repair Through Stent Implantation Trial. Ann Thorac Surg. 2021 Feb;111(2):463-470. doi: 10.1016/j.athoracsur.2020.05.090. Epub 2020 Jul 13.

  PMID: 32673661 BACKGROUND

• Rylski B, Hahn N, Beyersdorf F, Kondov S, Wolkewitz M, Blanke P, Plonek T, Czerny M, Siepe M. Fate of the dissected aortic arch after ascending replacement in type A aortic dissectiondagger. Eur J Cardiothorac Surg. 2017 Jun 1;51(6):1127-1134. doi: 10.1093/ejcts/ezx062.

  PMID: 28369453 BACKGROUND

• Evangelista A, Salas A, Ribera A, Ferreira-Gonzalez I, Cuellar H, Pineda V, Gonzalez-Alujas T, Bijnens B, Permanyer-Miralda G, Garcia-Dorado D. Long-term outcome of aortic dissection with patent false lumen: predictive role of entry tear size and location. Circulation. 2012 Jun 26;125(25):3133-41. doi: 10.1161/CIRCULATIONAHA.111.090266. Epub 2012 May 21.

  PMID: 22615344 BACKGROUND

• Kobuch R, Hilker M, Rupprecht L, Hirt S, Keyser A, Puehler T, Amman M, Zink W, Schmid C. Late reoperations after repaired acute type A aortic dissection. J Thorac Cardiovasc Surg. 2012 Aug;144(2):300-7. doi: 10.1016/j.jtcvs.2011.08.052. Epub 2011 Nov 12.

  PMID: 22078710 BACKGROUND

• Halstead JC, Meier M, Etz C, Spielvogel D, Bodian C, Wurm M, Shahani R, Griepp RB. The fate of the distal aorta after repair of acute type A aortic dissection. J Thorac Cardiovasc Surg. 2007 Jan;133(1):127-35. doi: 10.1016/j.jtcvs.2006.07.043. Epub 2006 Dec 4.

  PMID: 17198797 BACKGROUND

• Kimura N, Itoh S, Yuri K, Adachi K, Matsumoto H, Yamaguchi A, Adachi H. Reoperation for enlargement of the distal aorta after initial surgery for acute type A aortic dissection. J Thorac Cardiovasc Surg. 2015 Feb;149(2 Suppl):S91-8.e1. doi: 10.1016/j.jtcvs.2014.08.008. Epub 2014 Aug 13.

  PMID: 25224548 BACKGROUND

• Shrestha M, Pichlmaier M, Martens A, Hagl C, Khaladj N, Haverich A. Total aortic arch replacement with a novel four-branched frozen elephant trunk graft: first-in-man results. Eur J Cardiothorac Surg. 2013 Feb;43(2):406-10. doi: 10.1093/ejcts/ezs296. Epub 2012 May 31.

  PMID: 22653445 BACKGROUND

• Shrestha M, Haverich A, Martens A. Total aortic arch replacement with the frozen elephant trunk procedure in acute DeBakey type I aortic dissections. Eur J Cardiothorac Surg. 2017 Jan;51(suppl 1):i29-i34. doi: 10.1093/ejcts/ezw341.

  PMID: 28108566 BACKGROUND

• Dohle DS, Tsagakis K, Janosi RA, Benedik J, Kuhl H, Penkova L, Stebner F, Wendt D, Jakob H. Aortic remodelling in aortic dissection after frozen elephant trunkdagger. Eur J Cardiothorac Surg. 2016 Jan;49(1):111-7. doi: 10.1093/ejcts/ezv045. Epub 2015 Feb 24.

  PMID: 25715431 BACKGROUND

• Tsagakis K, Dohle DS, Wendt D, Wiese W, Benedik J, Lieder H, Thielmann M, Jakob H. Left subclavian artery rerouting and selective perfusion management in frozen elephant trunk surgery. Minim Invasive Ther Allied Technol. 2015;24(5):311-6. doi: 10.3109/13645706.2015.1069358.

  PMID: 26358834 BACKGROUND

• Bozso SJ, Nagendran J, Chu MWA, Kiaii B, El-Hamamsy I, Ouzounian M, Kempfert J, Starck C, Shahriari A, Moon MC. Single-Stage Management of Dynamic Malperfusion Using a Novel Arch Remodeling Hybrid Graft. Ann Thorac Surg. 2019 Dec;108(6):1768-1775. doi: 10.1016/j.athoracsur.2019.04.121. Epub 2019 Jun 27.

  PMID: 31254509 BACKGROUND

• Bozso SJ, Nagendran J, MacArthur RGG, Chu MWA, Kiaii B, El-Hamamsy I, Cartier R, Shahriari A, Moon MC. Dissected Aorta Repair Through Stent Implantation trial: Canadian results. J Thorac Cardiovasc Surg. 2019 May;157(5):1763-1771. doi: 10.1016/j.jtcvs.2018.09.120. Epub 2018 Oct 26.

  PMID: 30501947 BACKGROUND

• Montagner M, Kofler M, Heck R, Buz S, Starck C, Kurz S, Falk V, Kempfert J. Initial experience with the new type A arch dissection stent: restoration of supra-aortic vessel perfusion. Interact Cardiovasc Thorac Surg. 2021 Jul 26;33(2):276-283. doi: 10.1093/icvts/ivab085.

  PMID: 34010408 BACKGROUND

• Mehdiani A, Sugimura Y, Wollgarten L, Immohr MB, Bauer S, Schelzig H, Wagenhauser MU, Antoch G, Lichtenberg A, Akhyari P. Early Results of a Novel Hybrid Prosthesis for Treatment of Acute Aortic Dissection Type A With Distal Anastomosis Line Beyond Aortic Arch Zone Zero. Front Cardiovasc Med. 2022 Jul 14;9:892516. doi: 10.3389/fcvm.2022.892516. eCollection 2022.

  PMID: 35911517 BACKGROUND

• Wong RH, Baghai M, Yu SC, Underwood MJ. Aortic arch/elephant trunk procedure with Sienna(TM) graft and endovascular stenting of thoraco-abdominal aorta for treatment of complex chronic dissection. Ann Cardiothorac Surg. 2013 May;2(3):358-61. doi: 10.3978/j.issn.2225-319X.2013.05.03.

  PMID: 23977606 BACKGROUND

• Wong RH, Yu SC, Lau RW, Ng CS, Hui JW, Wan IY, Wan S, Ho AM, Underwood MJ. Delayed stent deformity and fracture of Djumbodis dissection system. Ann Thorac Surg. 2014 Jan;97(1):e17-20. doi: 10.1016/j.athoracsur.2013.07.127.

  PMID: 24384216 BACKGROUND

• Wong RH, Ho JY, Underwood MJ. Multimodality imaging assessment for Thoraflex hybrid total arch replacement. Asian Cardiovasc Thorac Ann. 2016 Jun;24(5):496-501. doi: 10.1177/0218492316643844. Epub 2016 Apr 11.

  PMID: 27072867 BACKGROUND

• Ho JYK, Chow SCY, Kwok MWT, Fujikawa T, Wong RHL. Total Aortic Arch Replacement and Frozen Elephant Trunk. Semin Thorac Cardiovasc Surg. 2021 Autumn;33(3):656-662. doi: 10.1053/j.semtcvs.2020.11.016. Epub 2020 Nov 9.

  PMID: 33181309 BACKGROUND

• Ho JYK, Bashir M, Jakob H, Wong RHL. Management of left subclavian artery in total arch replacement and frozen elephant trunk procedure. JTCVS Tech. 2021 Mar 29;7:36-40. doi: 10.1016/j.xjtc.2021.03.020. eCollection 2021 Jun. No abstract available.

  PMID: 34318200 BACKGROUND

Related Links

• Block randomization
• Sample size calculator
• Video 1
• Centre for Health Protection, Vital Statistics, Death Rates by Leading Causes of Death 1981-2000
• Hospital Authority Statistical Report 2009-2010, Page 28, Table 1.1
• Hospital Authority Statistical Report 2011-2012, Page 30, Table 1.2
• Wong RH, Ho JY, Bashir M, Jakob H. First-in-man implantation of Evita Open Neo in Hong Kong. CTSNet 2020.

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Central Study Contacts

Randolph Wong

CONTACT

+85255699431; wonhl1@surgery.cuhk.edu.hk

Jacky Ho

CONTACT

+85235052629; jackyho@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief of Division of Cardiothoracic Surgery, Department of Surgery

Model Details: Randomized control trial of two groups

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 21, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will become available when we complete our analysis and for a 12-month period
• Access Criteria: Approval needs to be sought from the Principal Investigator

Locations

CN (1)