EndovaScular Versus mediCaL mAnagement of Uncomplicated Type B Intramural heMatoma Trial (ESCLAIM)

NCT04808661 | Unknown

• 1 other identifier: KY-Q-2021-004-03
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a multicenter, open-label and prospective randomized controlled study to compare 1-year outcomes of uncomplicated type B intramural hematoma (IMH) patients undergoing thoracic endovascular aortic repair (TEVAR) plus optimal medical therapy (OMT) with that of those undergoing OMT alone. The primary objective is to test the hypothesis that 1-year aortic-related adverse events are lower in TEVAR plus OMT group than that in OMT alone group. The secondary objective is to test the hypothesis that 1-year all-cause mortality, aortic-related mortality and re-intervention are lower in TEVAR plus OMT group than that in OMT alone group.

Conditions

Intramural Hematoma

Outcome Measures

Primary Outcomes (1)

• Incidence of aortic-relative events

  A composite of hematoma malabsorption, aorta rupture, development of aortic dissection, aortic dilatation (aortic diameter \>55 mm) and ulcer-like projection \>10 mm in depth.

  One year

Secondary Outcomes (3)

• Rate of all-cause mortality

  One-year

• Rate of aortic-related mortality

  One-year

• Incidence of re-intervention

  One-year

Study Arms (2)

Intervention group

EXPERIMENTAL

Thoracic endovascular aortic repair plus optimal medical therapy

Procedure: Thoracic endovascular aortic repair plus optimal medical therapy

Conservative group

ACTIVE COMPARATOR

Optimal medical therapy

Drug: Optimal medical therapy

Interventions

Thoracic endovascular aortic repair plus optimal medical therapy PROCEDURE

Endovascular treatment (thoracic endovascular aortic repair) plus optimal medical therapy

Also known as: TEVAR plus OMT

Intervention group

Optimal medical therapy DRUG

Optimal medical therapy (strictly control of their blood pressure and heart rate)

Also known as: OMT

Conservative group

Eligibility Criteria

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

You may qualify if:

• Age \>18 years;
• Be confirmed as Stanford type B IMH by aorta computed tomography;
• From onset to first clinical attach \<90 days;
• The subject or legal guardian understands the nature of the study and agrees to its;
• provisions on a written informed consent form;
• Availability for the appropriate follow-up visits during the follow-up period;
• Capability to follow all study requirements.

You may not qualify if:

• Persistent or recurrent pain despite full medication,;
• Hemodynamic instability;
• Signs of rupture (periaortic hemorrhage);
• Depth of ULP \> 10 mm;
• Aortic diameter \> 55 mm;
• ULP around with calcification;
• Previous history of aortic-related procedures;
• Blunt thoracic aortic injury;
• Iatrogenic aortic injury;
• Inherited diseases: Turner syndrome, Marfan syndrome, Ehlers-Danlos syndrome, Loeys Dietz syndrome etc.;
• Aortitis: Giant cell arteritis, Takayasu arteritis etc.;
• Patients with malignant tumor whose life expectancy is less than 1 year;
• Intolerance to endotracheal intubation and general anesthesia;
• Pregnant women.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• Jiangmen Central Hospital: collaborator
• Shenzhen People's Hospital: collaborator
• Jieyang People's Hospital: collaborator
• Hanyang University: collaborator
• Henan Provincial Chest Hospital: collaborator
• Xinqiao Hospital of Chongqing: collaborator

Study Sites (1)

#106 Dongchuan Second Road, Yuexiu District

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (18)

• Mohr-Kahaly S, Erbel R, Kearney P, Puth M, Meyer J. Aortic intramural hemorrhage visualized by transesophageal echocardiography: findings and prognostic implications. J Am Coll Cardiol. 1994 Mar 1;23(3):658-64. doi: 10.1016/0735-1097(94)90751-x.

  PMID: 8113549 RESULT

• Nienaber CA, von Kodolitsch Y, Petersen B, Loose R, Helmchen U, Haverich A, Spielmann RP. Intramural hemorrhage of the thoracic aorta. Diagnostic and therapeutic implications. Circulation. 1995 Sep 15;92(6):1465-72. doi: 10.1161/01.cir.92.6.1465.

  PMID: 7664428 RESULT

• Evangelista A, Dominguez R, Sebastia C, Salas A, Permanyer-Miralda G, Avegliano G, Gomez-Bosh Z, Gonzalez-Alujas T, Garcia del Castillo H, Soler-Soler J. Prognostic value of clinical and morphologic findings in short-term evolution of aortic intramural haematoma. Therapeutic implications. Eur Heart J. 2004 Jan;25(1):81-7. doi: 10.1016/j.ehj.2003.10.011.

  PMID: 14683746 RESULT

• Moral S, Cuellar H, Avegliano G, Ballesteros E, Salcedo MT, Ferreira-Gonzalez I, Garcia-Dorado D, Evangelista A. Clinical Implications of Focal Intimal Disruption in Patients With Type B Intramural Hematoma. J Am Coll Cardiol. 2017 Jan 3;69(1):28-39. doi: 10.1016/j.jacc.2016.10.045.

  PMID: 28057247 RESULT

• Erbel R, Aboyans V, Boileau C, Bossone E, Bartolomeo RD, Eggebrecht H, Evangelista A, Falk V, Frank H, Gaemperli O, Grabenwoger M, Haverich A, Iung B, Manolis AJ, Meijboom F, Nienaber CA, Roffi M, Rousseau H, Sechtem U, Sirnes PA, Allmen RS, Vrints CJ; ESC Committee for Practice Guidelines. 2014 ESC Guidelines on the diagnosis and treatment of aortic diseases: Document covering acute and chronic aortic diseases of the thoracic and abdominal aorta of the adult. The Task Force for the Diagnosis and Treatment of Aortic Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2014 Nov 1;35(41):2873-926. doi: 10.1093/eurheartj/ehu281. Epub 2014 Aug 29. No abstract available.

  PMID: 25173340 RESULT

• Nienaber CA, Kische S, Rousseau H, Eggebrecht H, Rehders TC, Kundt G, Glass A, Scheinert D, Czerny M, Kleinfeldt T, Zipfel B, Labrousse L, Fattori R, Ince H; INSTEAD-XL trial. Endovascular repair of type B aortic dissection: long-term results of the randomized investigation of stent grafts in aortic dissection trial. Circ Cardiovasc Interv. 2013 Aug;6(4):407-16. doi: 10.1161/CIRCINTERVENTIONS.113.000463. Epub 2013 Aug 6.

  PMID: 23922146 RESULT

• Fattori R, Montgomery D, Lovato L, Kische S, Di Eusanio M, Ince H, Eagle KA, Isselbacher EM, Nienaber CA. Survival after endovascular therapy in patients with type B aortic dissection: a report from the International Registry of Acute Aortic Dissection (IRAD). JACC Cardiovasc Interv. 2013 Aug;6(8):876-82. doi: 10.1016/j.jcin.2013.05.003.

  PMID: 23968705 RESULT

• Mesar T, Lin MJ, Kabir I, Dexter DJ, Rathore A, Panneton JM. Medical therapy in type B aortic intramural hematoma is associated with a high failure rate. J Vasc Surg. 2020 Apr;71(4):1088-1096. doi: 10.1016/j.jvs.2019.07.084. Epub 2020 Feb 13.

  PMID: 32063446 RESULT

• Li DL, Zhang HK, Cai YY, Jin W, Chen XD, Tian L, Li M. Acute type B aortic intramural hematoma: treatment strategy and the role of endovascular repair. J Endovasc Ther. 2010 Oct;17(5):617-21. doi: 10.1583/10-3125.1a.

  PMID: 20939719 RESULT

• Hossack M, Patel S, Gambardella I, Neequaye S, Antoniou GA, Torella F. Endovascular vs. Medical Management for Uncomplicated Acute and Sub-acute Type B Aortic Dissection: A Meta-analysis. Eur J Vasc Endovasc Surg. 2020 May;59(5):794-807. doi: 10.1016/j.ejvs.2019.08.003. Epub 2019 Dec 30.

  PMID: 31899101 RESULT

• Kitai T, Kaji S, Yamamuro A, Tani T, Kinoshita M, Ehara N, Kobori A, Kita T, Furukawa Y. Impact of new development of ulcer-like projection on clinical outcomes in patients with type B aortic dissection with closed and thrombosed false lumen. Circulation. 2010 Sep 14;122(11 Suppl):S74-80. doi: 10.1161/CIRCULATIONAHA.109.927517.

  PMID: 20837929 RESULT

• Evangelista A, Dominguez R, Sebastia C, Salas A, Permanyer-Miralda G, Avegliano G, Elorz C, Gonzalez-Alujas T, Garcia Del Castillo H, Soler-Soler J. Long-term follow-up of aortic intramural hematoma: predictors of outcome. Circulation. 2003 Aug 5;108(5):583-9. doi: 10.1161/01.CIR.0000081776.49923.5A. Epub 2003 Jul 21.

  PMID: 12874185 RESULT

• Evangelista A, Mukherjee D, Mehta RH, O'Gara PT, Fattori R, Cooper JV, Smith DE, Oh JK, Hutchison S, Sechtem U, Isselbacher EM, Nienaber CA, Pape LA, Eagle KA; International Registry of Aortic Dissection (IRAD) Investigators. Acute intramural hematoma of the aorta: a mystery in evolution. Circulation. 2005 Mar 1;111(8):1063-70. doi: 10.1161/01.CIR.0000156444.26393.80. Epub 2005 Feb 14.

  PMID: 15710757 RESULT

• Piffaretti G, Lomazzi C, Benedetto F, Pipito N, Castelli P, Trimarchi S, Dorigo W, Tozzi M. Best Medical Treatment and Selective Stent-GraftRepair for Acute Type B Aortic Intramural Hematoma. Semin Thorac Cardiovasc Surg. 2018 Autumn;30(3):279-287. doi: 10.1053/j.semtcvs.2018.02.006. Epub 2018 Feb 9.

  PMID: 29432889 RESULT

• Monnin-Bares V, Thony F, Rodiere M, Bach V, Hacini R, Blin D, Ferretti G. Endovascular stent-graft management of aortic intramural hematomas. J Vasc Interv Radiol. 2009 Jun;20(6):713-21. doi: 10.1016/j.jvir.2009.02.013. Epub 2009 Apr 23.

  PMID: 19398351 RESULT

• Felisaz A, Dufranc J, Heyndrickx M, Palcau L, Gouicem D, Berger L. Midterm results of type B intramural hematoma endovascular treatment. Ann Vasc Surg. 2015 Jul;29(5):898-904. doi: 10.1016/j.avsg.2014.12.024. Epub 2015 Feb 26.

  PMID: 25728332 RESULT

• Chen Q, Jiang D, Kuang F, Shan Z. The evolution of treatments for uncomplicated type B intramural hematoma patients. J Card Surg. 2020 Mar;35(3):580-590. doi: 10.1111/jocs.14431. Epub 2020 Jan 16.

  PMID: 31945227 RESULT

• Evangelista A, Czerny M, Nienaber C, Schepens M, Rousseau H, Cao P, Moral S, Fattori R. Interdisciplinary expert consensus on management of type B intramural haematoma and penetrating aortic ulcer. Eur J Cardiothorac Surg. 2015 Feb;47(2):209-17. doi: 10.1093/ejcts/ezu386. Epub 2014 Nov 10.

  PMID: 25385219 RESULT

MeSH Terms

Interventions

Endovascular Aneurysm Repair

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Officials

• Jianfang Luo, MD

  Guangdong Provincial People's Hospital

  STUDY CHAIR

Central Study Contacts

Fan Yang, MD

CONTACT

13922783426; 715886618@qq.com

Guokui Zhang, MM

CONTACT

13622266656; 772379801@qq.com

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

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 22, 2021
• Study Start: March 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2024
• Last Updated: June 3, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)