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

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03707743

Acronym

STABILISE

Enrollment

200

Registered

2018-10-16

Start date

2018-10-30

Completion date

2026-12-30

Last updated

2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Dissection

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/or open surgical procedures (unrelated to dissection) within 30 days before or after dissection repair.

Design outcomes

Primary

Measure	Time frame	Description
Technical success of the STABILISE procedure	30 day	patency of visceral vessels and iliac arteries
Clinical success	30 day	absence of major adverse events (mortality, neurological complications, cardiological complications, respiratory complications, intestinal ischemia

Countries

Australia, Austria, Brazil, France, Germany, Italy, Netherlands, New Zealand, Portugal, Spain, Sweden, Turkey (Türkiye), United Kingdom, United States

Outcome results