CRATOS - Evaluation of Cratosâ„¢ Branch Stent Graft System in Treatment of Descending Aorta Lesions (NCT05874206) | Clinical Trial Compass
RecruitingNot Applicable
CRATOS - Evaluation of Cratosâ„¢ Branch Stent Graft System in Treatment of Descending Aorta Lesions
Switzerland130 participantsStarted 2024-03-08
Plain-language summary
The goal of this prospective, interventional, multicentre, single-arm performance objective study is to evaluate efficacy and safety of Cratosâ„¢ 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
Who can participate
Age range18 Years
SexALL
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
✓. 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:
✓. Must have appropriate LSA landing zone, defined as:
✓. Must have appropriate distal aortic landing zone, defined as:
Exclusion criteria
✕. 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 .