Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03707743