Registry of Patients With Acute/Subacute Type B Aortic Dissection Treated by Means of the STABILISE Technique (STABILISE)

Aortic Dissection Clinical Trial

— STABILISE  

Official title:

A Physician-initiated, International, Multi-center, Prospective and Retrospective, Non Randomized, Observational Registry of Patients With Acute/Subacute Type B Aortic Dissection Treated by Means of the STABILISE Technique.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03707743
• Other study ID #: STABILISE
• Status: Recruiting
• Start date: October 30, 2018
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2024
• Source: IRCCS San Raffaele
• Contact: Germano Melissano, MD
• Phone: +390226437146
• Email: melissano.germano[@]hsr.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of the study is to evaluate results of patients treated with the STABILISE technique for acute/subacute aortic dissection. Results and postoperative events are reported in accordance with the current reporting standards for endovascular aortic repair prepared and revised by the Ad Hoc Committee for Standardized Reporting Practices in Vascular Surgery of The Society for Vascular Surgery/American Association for Vascular Surgery

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with = 18 years of age;
• Patients presenting with an acute (up to two weeks from the onset) and subacute (between 3 and 12 weeks from the onset) type B dissection with a proximal suitable non-dissected landing zone in the aortic arch or descending thoracic aorta (supra-aortic trunks debranching may be employed to obtain an adequate proximal landing zone);
• Total aortic diameter of the abdominal aorta (from supra-celiac to infra-renal level) must not exceed 42 mm;
• Patients able to sign specific informed consent for the study.

Exclusion Criteria:

• Patients with chronic type B aortic dissection (more than 12 weeks from the onset);
• Patients with acute type B aortic dissection not treated according to the following treatment protocol;
• Unwilling or unable to comply with the follow-up schedule;
• Inability or refusal to give informed consent;
• Simultaneously participating in another investigative device or drug study;
• Frank rupture;
• Systemic infection (eg, sepsis);
• Allergy to stainless steel, polyester, solder (tin, silver), polypropylene, nitinol, or gold;
• Untreatable reaction to contrast, which, in the opinion of the investigator, cannot be adequately premedicated;
• Surgical or endovascular AAA repair within 30 days before or after dissection repair;
• Previous placement of a thoracic endovascular graft;
• Prior open repair involving the descending thoracic aorta, including the supra-renal aorta and/or arch;
• Interventional and/or open surgical procedures (unrelated to dissection) within 30 days before or after dissection repair.

Related Conditions & MeSH terms

• Aortic Dissection

Locations

Country	Name	City	State
Australia	St Vincent's Private Hospital Melbourne	Melbourne	Victoria
Australia	Austin Hospital Heidelberg	Victoria Park
Austria	Herz Im Zentrum	Neulengbach	Hauptplatz
Brazil	Centervasc-Rio	Rio De Janeiro
France	Hopital de la Timone	Marseille
France	Hôpital Européen Georges Pompidou	Paris
Germany	German Aortic Center Hamburg	Amburgo	Hamburg
Germany	Johannes Gutenberg-University	Hamburg
Germany	Universitätsklinikum Münster	Münster	Renania Settentrionale-Vestfalia
Germany	Klinikum Nürnberg Süd	Nürnberg	Franconia
Italy	Ospedale San Giovanni di Dio	Firenze
Italy	ASST Lecco	Lecco
Italy	IRCCS San Raffaele Hospital	Milano
Italy	AOU Modena	Modena
Italy	AOU Policlinico Umberto I	Roma
Italy	Ospedale Civile SS. Annunziata	Sassari
Italy	AOUI Verona	Verona
Netherlands	Maastricht Heart+Vascular Center	Maastricht
New Zealand	Waikato Hospital	Hamilton
Portugal	Bristish Hospital XXI / Instituto Cardiovascular de Lisboa	Lisboa
Spain	Hospital Clínic de Barcelona	Barcelona	Catalonia
Sweden	University of Lund, General Hospital, Malmö	Malmö
Turkey	University School of Medicine Department of Cardiovascular Surgery	Ankara
United Kingdom	Royal Brompton & Harefield NHS Foundation	Chelsea	London
United Kingdom	London Guy's & St Thomas' NHS Foundation Trust	London
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Cooper University Health Care	Camden	New Jersey
United States	UNC Hospitals	Chapel Hill	North Carolina
United States	Hartford Hospital	Hartford	Connecticut
United States	Columbia University Irving Medical Center	New York	New York
United States	Knight Cardiovascular Institute	Portland	Oregon
United States	Providence Heart and Vascular Institute	Portland	Oregon
United States	Mayo Clinic	Rochester	New York
United States	Falk Cardiovascular Research Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Brazil,  France,  Germany,  Italy,  Netherlands,  New Zealand,  Portugal,  Spain,  Sweden,  Turkey,  United Kingdom, 

References & Publications (10)

Chaikof EL, Fillinger MF, Matsumura JS, Rutherford RB, White GH, Blankensteijn JD, Bernhard VM, Harris PL, Kent KC, May J, Veith FJ, Zarins CK. Identifying and grading factors that modify the outcome of endovascular aortic aneurysm repair. J Vasc Surg. 2002 May;35(5):1061-6. doi: 10.1067/mva.2002.123991. No abstract available. — View Citation

Dake MD, Thompson M, van Sambeek M, Vermassen F, Morales JP; DEFINE Investigators. DISSECT: a new mnemonic-based approach to the categorization of aortic dissection. Eur J Vasc Endovasc Surg. 2013 Aug;46(2):175-90. doi: 10.1016/j.ejvs.2013.04.029. Epub 2013 May 28. — View Citation

Fattori R, Cao P, De Rango P, Czerny M, Evangelista A, Nienaber C, Rousseau H, Schepens M. Interdisciplinary expert consensus document on management of type B aortic dissection. J Am Coll Cardiol. 2013 Apr 23;61(16):1661-78. doi: 10.1016/j.jacc.2012.11.072. — View Citation

Fillinger MF, Greenberg RK, McKinsey JF, Chaikof EL; Society for Vascular Surgery Ad Hoc Committee on TEVAR Reporting Standards. Reporting standards for thoracic endovascular aortic repair (TEVAR). J Vasc Surg. 2010 Oct;52(4):1022-33, 1033.e15. doi: 10.1016/j.jvs.2010.07.008. No abstract available. — View Citation

Hofferberth SC, Nixon IK, Boston RC, McLachlan CS, Mossop PJ. Stent-assisted balloon-induced intimal disruption and relamination in aortic dissection repair: the STABILISE concept. J Thorac Cardiovasc Surg. 2014 Apr;147(4):1240-5. doi: 10.1016/j.jtcvs.2013.03.036. Epub 2013 Apr 17. — View Citation

Lombardi JV, Cambria RP, Nienaber CA, Chiesa R, Teebken O, Lee A, Mossop P, Bharadwaj P; STABLE investigators. Prospective multicenter clinical trial (STABLE) on the endovascular treatment of complicated type B aortic dissection using a composite device design. J Vasc Surg. 2012 Mar;55(3):629-640.e2. doi: 10.1016/j.jvs.2011.10.022. Epub 2011 Dec 9. — View Citation

Melissano G, Bertoglio L, Rinaldi E, Civilini E, Tshomba Y, Kahlberg A, Agricola E, Chiesa R. Volume changes in aortic true and false lumen after the "PETTICOAT" procedure for type B aortic dissection. J Vasc Surg. 2012 Mar;55(3):641-51. doi: 10.1016/j.jvs.2011.10.025. Epub 2012 Jan 28. — View Citation

Melissano G, Bertoglio L, Rinaldi E, Mascia D, Kahlberg A, Loschi D, De Luca M, Monaco F, Chiesa R. Satisfactory short-term outcomes of the STABILISE technique for type B aortic dissection. J Vasc Surg. 2018 Oct;68(4):966-975. doi: 10.1016/j.jvs.2018.01.029. Epub 2018 Mar 30. — View Citation

Nienaber CA, Kische S, Zeller T, Rehders TC, Schneider H, Lorenzen B, Bunger C, Ince H. Provisional extension to induce complete attachment after stent-graft placement in type B aortic dissection: the PETTICOAT concept. J Endovasc Ther. 2006 Dec;13(6):738-46. doi: 10.1583/06-1923.1. — View Citation

Riambau V, Bockler D, Brunkwall J, Cao P, Chiesa R, Coppi G, Czerny M, Fraedrich G, Haulon S, Jacobs MJ, Lachat ML, Moll FL, Setacci C, Taylor PR, Thompson M, Trimarchi S, Verhagen HJ, Verhoeven EL, Esvs Guidelines Committee, Kolh P, de Borst GJ, Chakfe N, Debus ES, Hinchliffe RJ, Kakkos S, Koncar I, Lindholt JS, Vega de Ceniga M, Vermassen F, Verzini F, Document Reviewers, Kolh P, Black JH 3rd, Busund R, Bjorck M, Dake M, Dick F, Eggebrecht H, Evangelista A, Grabenwoger M, Milner R, Naylor AR, Ricco JB, Rousseau H, Schmidli J. Editor's Choice - Management of Descending Thoracic Aorta Diseases: Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2017 Jan;53(1):4-52. doi: 10.1016/j.ejvs.2016.06.005. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success of the STABILISE procedure	patency of visceral vessels and iliac arteries	30 day
Primary	Clinical success	absence of major adverse events (mortality, neurological complications, cardiological complications, respiratory complications, intestinal ischemia	30 day