Active — Not RecruitingNot Applicable

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

United States, Australia, Austria200 participantsStarted 2018-10-30

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Technical success of the STABILISE procedure

Timeframe: 30 day

Clinical success

Timeframe: 30 day

Trial details

NCT IDNCT03707743

SponsorIRCCS San Raffaele

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-11-30

View on ClinicalTrials.gov More Aortic Dissection trials