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

NCT03707743 | Active Not Recruiting

• 1 other identifier: STABILISE
• Study Type: observational
• Target: 200
• Locations: 13 countries
• Sites: 32

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

Conditions

Aortic Dissection

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (34)

Falk Cardiovascular Research Center

Stanford, California, 94305, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Cooper University Health Care

Camden, New Jersey, 08103, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Mayo Clinic

Rochester, New York, 55902, United States

Location

UNC Hospitals

Chapel Hill, North Carolina, 27514, United States

Location

Providence Heart and Vascular Institute

Portland, Oregon, 97225, United States

Location

Knight Cardiovascular Institute

Portland, Oregon, 97239, United States

Location

Austin Hospital Heidelberg

Victoria Park, Australia, 3084, Australia

Location

St Vincent's Private Hospital Melbourne

Melbourne, Victoria, 3002, Australia

Location

Herz Im Zentrum

Neulengbach, Hauptplatz, 3040, Austria

Location

Centervasc-Rio

Rio de Janeiro, Brazil, 22271-110, Brazil

Location

Hopital de la Timone

Marseille, France, 13385, France

Location

Hôpital Européen Georges Pompidou

Paris, Paris, 75015, France

Location

Klinikum Nürnberg Süd

Nuremberg, Franconia, 90471, Germany

Location

Johannes Gutenberg-University

Hamburg, Germany, 55122, Germany

Location

German Aortic Center Hamburg

Hamburg, Hamburg, 20246, Germany

Location

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

Location

ASST Lecco

Lecco, Italy, 23900, Italy

Location

IRCCS San Raffaele Hospital

Milan, Italy, 20132, Italy

Location

AOU Modena

Modena, Italy, 41124, Italy

Location

AOU Policlinico Umberto I

Roma, Italy, 00161, Italy

Location

Ospedale San Giovanni di Dio

Florence, Italy

Location

Ospedale Civile SS. Annunziata

Sassari, Italy

Location

AOUI Verona

Verona, 37126, Italy

Location

Maastricht Heart+Vascular Center

Maastricht, Netherlands, 6229HX, Netherlands

Location

Waikato Hospital

Hamilton, New Zealand

Location

Bristish Hospital XXI / Instituto Cardiovascular de Lisboa

Lisbon, Portugal, 1600-209, Portugal

Location

Hospital Clínic de Barcelona

Barcelona, Catalonia, 08036, Spain

Location

University of Lund, General Hospital, Malmö

Malmo, Sweden, Sweden

Location

University School of Medicine Department of Cardiovascular Surgery

Ankara, Turkey (Türkiye)

Location

Royal Brompton & Harefield NHS Foundation

Chelsea, London, SW3 6NP, United Kingdom

Location

London Guy's & St Thomas' NHS Foundation Trust

London, London, SE1 9RT, United Kingdom

Location

Related Publications (10)

• 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.

  PMID: 23500232 BACKGROUND

• 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.

  PMID: 17154712 BACKGROUND

• 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.

  PMID: 22285874 BACKGROUND

• 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.

  PMID: 22169668 BACKGROUND

• 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.

  PMID: 29606568 BACKGROUND

• 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.

  PMID: 23601749 BACKGROUND

• 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.

  PMID: 20888533 BACKGROUND

• 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.

  PMID: 12021728 BACKGROUND

• 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.

  PMID: 23721817 BACKGROUND

• 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.

  PMID: 28081802 BACKGROUND

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

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

Study Officials

• Germano Melissano, MD

  IRCCS San Raffaele Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: October 16, 2018
• Study Start: October 30, 2018
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

US (9); NZ (1); BR (1); AU (1); NL (1); IT (7); ES (1); FR (2); SE (1); TU (1); GB (2); DE (4); PT (1)