CRATOS - Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions

Официальное название

Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions

Обзор

The goal of this prospective, interventional, multicentre, single-arm performance objective study is to evaluate efficacy and safety of Cratos™ Branch Stent Graft System in treatment of lesions (dissection, IMH and PAU in descending aorta. The main question\[s\] it aims to answer are: * 30-day all-cause Mortality rate * Composite of the following events from the time of enrolment through 12-month: * Device Technical Success * Absence of: Aortic rupture, Lesion-related mortality, Disabling Stroke, Permanent paraplegia, Permanent paraparesis, New onset renal failure requiring permanent dialysis, Additional unanticipated post-procedural surgical or interventional procedure related to the device, procedure, or withdrawal of the device system Participants will come for hospital office visits 1, 6, 12, 24-, 36-, 48- and 60-months post-procedure for the following, but not limited to assessments: * Physical examination * Modified Rankin scale * Tarlov scoring scale * CTA

Вмешательства

• Устройство Cratos™ Stent Graft
  Cratos™ Stent Graft TEVAR procedure for the treatment of aortic lesions.

Первичные конечные точки

• Mortality [Срок оценки: 30-day]

Критерии участия

Критерии включения

• Presence of thoracic aortic pathology (Dissection, including IMH and ULP; and PAU) deemed to warrant surgical repair which requires proximal graft placement in Zone 2
• Age ≥18 years at time of informed consent signature
• Informed Consent Form (ICF) is signed by Subject or legal representative
• Must have appropriate proximal aortic landing zone, defined as:

• Landing zone inner diameters between 23-41 mm
• The length of landing zone ≥15mm
• Landing without heavily calcified or heavily thrombosed
• Dissection Patients: Primary entry tear must be distal to LSA, and proximal extent of the proximal landing zone must not be dissected.
• For patients with prior replacement of the ascending aorta and/or aortic arch by a surgical graft, there must be at least 2 cm of landing zone proximal to the most distal anastomosis site.
• Must have appropriate LSA landing zone, defined as:

• Inner diameters of LSA 5-14 mm
• Minimum length of Left subclavian artery is 25 mm
• Target branch vessel landing zone must be in native aorta that cannot be severely tortuous , aneurysmal, dissected, heavily calcified, or heavily thrombosed.
• Must have appropriate distal aortic landing zone, defined as:

• Aortic inner diameters between 18-44 mm
• Landing zone cannot be heavily calcified, or heavily thrombosed.
• For isolated PAU, outer curvature length must be ≥ 2cm proximal to the celiac artery
• Landing zone in native aorta

Критерии исключения

• Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair
• Previous endovascular repair of the ascending aorta
• Infected aorta, active systemic infection
• Surgery within 30 days prior to enrolment with the exception of placement of vascular conduit for access .
• Life expectancy <1 years
• Myocardial infarction within 6 weeks prior to treatment
• Stroke within 6 weeks prior to treatment.
• Pregnant or breastfeeding female
• Patient has an active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication) that may place the patient at increased risk of endovascular infection.
• Degenerative connective tissue disease, e.g., Marfan's or Ehlers-Danlos Syndrome
• Participation in another drug or medical device study within one year of study enrolment
• Known history of drug abuse within one year of treatment
• Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access
• Planned coverage of celiac artery
• Allergic to contrast agents, anaesthetics and delivery materials
• Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
• Patient with a history of a hypercoagulability disorder and/or is currently in a hypercoagulability state
• Persistent refractory shock (systolic blood pressure <90 mm Hg)
• Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) <30 (ml/min/1.73 m2) or currently requiring dialysis
• Contraindications to antiplatelet drugs and anticoagulants
• Investigator judged that not suitable for interventional treatment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• University Hospital Zurich — Zurich

Идентификаторы

NCT: NCT05874206 · ENDO_E23-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗