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

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.

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

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Dissection

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Australia
  • Australia
    • Victoria Park, Australia, Australia, 3084
      • Austin Hospital Heidelberg
  • Victoria
    • Melbourne, Victoria, Australia, 3002
      • St Vincent's Private Hospital Melbourne
• Austria
  • Hauptplatz
    • Neulengbach, Hauptplatz, Austria, 3040
      • Herz Im Zentrum
• Brazil
  • Brazil
    • Rio de Janeiro, Brazil, Brazil, 22271-110
      • Centervasc-Rio
• France
  • France
    • Marseille, France, France, 13385
      • Hôpital de la Timone
  • Paris
    • Paris, Paris, France, 75015
      • Hôpital Européen Georges Pompidou
• Germany
  • Franconia
    • Nuremberg, Franconia, Germany, 90471
      • Klinikum Nurnberg Sud
  • Germany
    • Hamburg, Germany, Germany, 55122
      • Johannes Gutenberg-University
  • Hamburg
    • Hamburg, Hamburg, Germany, 20246
      • German Aortic Center Hamburg
  • North Rhine-Westphalia
    • Münster, North Rhine-Westphalia, Germany, 48149
      • Universitätsklinikum Münster
• Italy
  • Florence, Italy
    • Ospedale San Giovanni di Dio
  • Sassari, Italy
    • Ospedale Civile SS. Annunziata
  • Verona, Italy, 37126
    • AOUI Verona
  • Italy
    • Lecco, Italy, Italy, 23900
      • ASST Lecco
    • Milan, Italy, Italy, 20132
      • IRCCS San Raffaele Hospital
    • Modena, Italy, Italy, 41124
      • AOU Modena
    • Roma, Italy, Italy, 00161
      • AOU Policlinico Umberto I
• Netherlands
  • Netherlands
    • Maastricht, Netherlands, Netherlands, 6229HX
      • Maastricht Heart+Vascular Center
• New Zealand
  • Hamilton, New Zealand
    • Waikato Hospital
• Portugal
  • Portugal
    • Lisbon, Portugal, Portugal, 1600-209
      • Bristish Hospital XXI / Instituto Cardiovascular de Lisboa
• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08036
      • Hospital Clinic De Barcelona
• Sweden
  • Sweden
    • Malmo, Sweden, Sweden
      • University of Lund, General Hospital, Malmö
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
    • University School of Medicine Department of Cardiovascular Surgery
• United Kingdom
  • London
    • Chelsea, London, United Kingdom, SW3 6NP
      • Royal Brompton & Harefield NHS Foundation
    • London, London, United Kingdom, SE1 9RT
      • London Guy's & St Thomas' NHS Foundation Trust
• United States
  • California
    • Stanford, California, United States, 94305
      • Falk Cardiovascular Research Center
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Health Care
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center
    • Rochester, New York, United States, 55902
      • Mayo Clinic
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • UNC Hospitals
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence Heart and Vascular Institute
    • Portland, Oregon, United States, 97239
      • Knight Cardiovascular Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute/subacute type B aortic dissection treated by means of the STABILISE technique

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele
• Investigators: Principal Investigator: Germano Melissano, MD, IRCCS San Raffaele Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2018
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: October 12, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Dissection
• Other Study ID Numbers: STABILISE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No