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NCT Number: NCT03707743

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Austin Hospital Heidelberg, Victoria Park, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Technical success of the STABILISE procedure

    Time frame: 30 day

    patency of visceral vessels and iliac arteries

  2. Clinical success

    Time frame: 30 day

    absence of major adverse events (mortality, neurological complications, cardiological complications, respiratory complications, intestinal ischemia

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study 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.

Acronym: STABILISE

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Oct 16, 2018
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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