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

San Donato Group (GSD)

Status: Active, not recruiting

Conditions: Aortic Dissection

Study type: Observational

Funder types: Other

Identifiers

NCT03707743

STABILISE

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.