Aortic DissectionSTABILISENCT03707743
Registry of Patients With Acute/Subacute Type B Aortic Dissection Treated by Means of the STABILISE Technique (STABILISE)
An observational study of Aortic Dissection, run by IRCCS San Raffaele at 34 sites in 14 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Dissection
- How many people
- 200 participants
- Where
- 34 sitesin 14 countries
- Study dates
- 30 Oct 2018to 30 Dec 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute/subacute type B aortic dissection treated by means of the STABILISE technique
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 13Show fewer
- 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.
Trial locations and contacts
34 sites in 14 countries.
34 sites in 14 countries
United States9 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Cooper University Health Care
Camden, New Jersey, 08103
UNC Hospitals
Chapel Hill, North Carolina, 27514
Hartford Hospital
Hartford, Connecticut, 06102
Columbia University Irving Medical Center
New York, New York, 10032
Providence Heart and Vascular Institute
Portland, Oregon, 97225
Knight Cardiovascular Institute
Portland, Oregon, 97239
Mayo Clinic
Rochester, New York, 55902
Falk Cardiovascular Research Center
Stanford, California, 94305
Italy7 sites
Ospedale San Giovanni di Dio
Florence
ASST Lecco
Lecco, Italy, 23900
IRCCS San Raffaele Hospital
Milan, Italy, 20132
AOU Modena
Modena, Italy, 41124
AOU Policlinico Umberto I
Roma, Italy, 00161
Ospedale Civile SS. Annunziata
Sassari
AOUI Verona
Verona, 37126
Germany4 sites
German Aortic Center Hamburg
Hamburg, Free and Hanseatic City of Hamburg, 20246
Johannes Gutenberg-University
Hamburg, Germany, 55122
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149
Klinikum Nürnberg Süd
Nuremberg, Franconia, 90471
Australia2 sites
St Vincent's Private Hospital Melbourne
Melbourne, Victoria, 3002
Austin Hospital Heidelberg
Victoria Park, Australia, 3084
France2 sites
Hopital de la Timone
Marseille, France, 13385
Hôpital Européen Georges Pompidou
Paris, Paris, 75015
United Kingdom2 sites
Royal Brompton & Harefield NHS Foundation
Chelsea, London, SW3 6NP
London Guy's & St Thomas' NHS Foundation Trust
London, London, SE1 9RT
Netherlands1 site
Maastricht Heart+Vascular Center
Maastricht, Netherlands, 6229HX
Portugal1 site
Bristish Hospital XXI / Instituto Cardiovascular de Lisboa
Lisbon, Portugal, 1600-209
Turkey (Türkiye)1 site
University School of Medicine Department of Cardiovascular Surgery
Ankara
About this study
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.
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
- Medical subject headings
- Aortic Dissection
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success of the STABILISE procedure
patency of visceral vessels and iliac arteries
Measured: 30 day
Clinical success
absence of major adverse events (mortality, neurological complications, cardiological complications, respiratory complications, intestinal ischemia
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start30 Oct 2018
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Germano Melissano, IRCCS San Raffaele
- Investigators
- Germano Melissano, MD, Principal investigator, IRCCS San Raffaele Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707743
- Sponsor's protocol ID
- STABILISE
- Acronym
- STABILISE
- Status last verified
- Jan 2026
- First submitted
- 12 Oct 2018
- Last updated
- 15 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 23500232Nienaber 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.
PubMed 17154712Melissano 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.
PubMed 22285874Lombardi 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.
PubMed 22169668Melissano 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.
PubMed 29606568Hofferberth 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.
PubMed 23601749Fillinger 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.
PubMed 20888533Chaikof 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.
PubMed 12021728Dake 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.
PubMed 23721817Riambau 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.
PubMed 28081802
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03707743
- Acronym / sponsor ID
- STABILISE / STABILISE
- Conditions
- Aortic Dissection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 16 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute/subacute type B aortic dissection treated by means of the STABILISE technique
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Technical success of the STABILISE procedure
Time frame: 30 day
patency of visceral vessels and iliac arteries
Clinical success
Time frame: 30 day
absence of major adverse events (mortality, neurological complications, cardiological complications, respiratory complications, intestinal ischemia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Background: PubMed 23500232Fattori 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.
- Background: PubMed 17154712Nienaber 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.
- Background: PubMed 22285874Melissano 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.
- Background: PubMed 22169668Lombardi 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.
- Background: PubMed 29606568Melissano 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.
- Background: PubMed 23601749Hofferberth 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.
- Background: PubMed 20888533Fillinger 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.
- Background: PubMed 12021728Chaikof 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.
- Background: PubMed 23721817Dake 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.
- Background: PubMed 28081802Riambau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Germano Melissano, MD principal investigator
IRCCS San Raffaele Hospital
34 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Dissection, run by IRCCS San Raffaele at 34 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Italy, Germany, Australia, France and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success of the STABILISE procedure (time frame: 30 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03707743, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.