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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03707743




Registration number
NCT03707743
Ethics application status
Date submitted
12/10/2018
Date registered
16/10/2018
Date last updated
5/01/2024

Titles & IDs
Public title
Registry of Patients With Acute/Subacute Type B Aortic Dissection Treated by Means of the STABILISE Technique (STABILISE)
Scientific 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.
Secondary ID [1] 0 0
STABILISE
Universal Trial Number (UTN)
Trial acronym
STABILISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Dissection 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Technical success of the STABILISE procedure
Timepoint [1] 0 0
30 day
Primary outcome [2] 0 0
Clinical success
Timepoint [2] 0 0
30 day

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2024
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St Vincent's Private Hospital Melbourne - Melbourne
Recruitment hospital [2] 0 0
Austin Hospital Heidelberg - Victoria Park
Recruitment postcode(s) [1] 0 0
3002 - Melbourne
Recruitment postcode(s) [2] 0 0
3084 - Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
Austria
State/province [8] 0 0
Hauptplatz
Country [9] 0 0
Brazil
State/province [9] 0 0
Rio De Janeiro
Country [10] 0 0
France
State/province [10] 0 0
Marseille
Country [11] 0 0
France
State/province [11] 0 0
Paris
Country [12] 0 0
Germany
State/province [12] 0 0
Franconia
Country [13] 0 0
Germany
State/province [13] 0 0
Hamburg
Country [14] 0 0
Germany
State/province [14] 0 0
Renania Settentrionale-Vestfalia
Country [15] 0 0
Italy
State/province [15] 0 0
Firenze
Country [16] 0 0
Italy
State/province [16] 0 0
Lecco
Country [17] 0 0
Italy
State/province [17] 0 0
Milano
Country [18] 0 0
Italy
State/province [18] 0 0
Modena
Country [19] 0 0
Italy
State/province [19] 0 0
Roma
Country [20] 0 0
Italy
State/province [20] 0 0
Sassari
Country [21] 0 0
Italy
State/province [21] 0 0
Verona
Country [22] 0 0
Netherlands
State/province [22] 0 0
Maastricht
Country [23] 0 0
New Zealand
State/province [23] 0 0
Hamilton
Country [24] 0 0
Portugal
State/province [24] 0 0
Lisboa
Country [25] 0 0
Spain
State/province [25] 0 0
Catalonia
Country [26] 0 0
Sweden
State/province [26] 0 0
Malmö
Country [27] 0 0
Turkey
State/province [27] 0 0
Ankara
Country [28] 0 0
United Kingdom
State/province [28] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
IRCCS San Raffaele
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT03707743
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Germano Melissano, MD
Address 0 0
IRCCS San Raffaele Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Germano Melissano, MD
Address 0 0
Country 0 0
Phone 0 0
+390226437146
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03707743