Clinical trial NCT03707743: Registry of Patients With Acute/Subacute Type B Aortic Dissection Treated by Means of the STABILISE Technique (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.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Aortic Dissection
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2018-10-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute/subacute type B aortic dissection treated by means of the STABILISE technique

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: Technical success of the STABILISE procedure
timeFrame: 30 day
measure: Clinical success
timeFrame: 30 day
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Falk Cardiovascular Research Center
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Camden
country: United States
facility: Cooper University Health Care
state: New Jersey
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Rochester
country: United States
facility: Mayo Clinic
state: New York
city: Chapel Hill
country: United States
facility: UNC Hospitals
state: North Carolina
city: Portland
country: United States
facility: Providence Heart and Vascular Institute
state: Oregon
city: Portland
country: United States
facility: Knight Cardiovascular Institute
state: Oregon
city: Melbourne
country: Australia
facility: St Vincent's Private Hospital Melbourne
state: Victoria
city: Victoria Park
country: Australia
facility: Austin Hospital Heidelberg
city: Neulengbach
country: Austria
facility: Herz Im Zentrum
state: Hauptplatz
city: Rio De Janeiro
country: Brazil
facility: Centervasc-Rio
city: Marseille
country: France
facility: Hopital de la Timone
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Süd
state: Franconia
city: Amburgo
country: Germany
facility: German Aortic Center Hamburg
state: Hamburg
city: Münster
country: Germany
facility: Universitätsklinikum Münster
state: Renania Settentrionale-Vestfalia
city: Hamburg
country: Germany
facility: Johannes Gutenberg-University
city: Firenze
country: Italy
facility: Ospedale San Giovanni di Dio
city: Lecco
country: Italy
facility: ASST Lecco
city: Milano
country: Italy
facility: IRCCS San Raffaele Hospital
city: Modena
country: Italy
facility: AOU Modena
city: Roma
country: Italy
facility: AOU Policlinico Umberto I
city: Sassari
country: Italy
facility: Ospedale Civile SS. Annunziata
city: Verona
country: Italy
facility: AOUI Verona
city: Maastricht
country: Netherlands
facility: Maastricht Heart+Vascular Center
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Lisboa
country: Portugal
facility: Bristish Hospital XXI / Instituto Cardiovascular de Lisboa
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
state: Catalonia
city: Malmö
country: Sweden
facility: University of Lund, General Hospital, Malmö
city: Ankara
country: Turkey
facility: University School of Medicine Department of Cardiovascular Surgery
city: Chelsea
country: United Kingdom
facility: Royal Brompton & Harefield NHS Foundation
state: London
city: London
country: United Kingdom
facility: London Guy's & St Thomas' NHS Foundation Trust
Study officials:
affiliation: IRCCS San Raffaele Hospital
name: Germano Melissano, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
citation: 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.
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.
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.