Study of Cratos17 Branch Stent Graft System for Treating Lesions in the Descending Aorta

What this Trial Is About

Researchers are evaluating the Cratos Branch Stent Graft System for treating lesions in the descending aorta, including aortic dissection type B, intramural hematoma, and penetrating aortic ulcer. This prospective, interventional, multicenter, single-arm study focuses on measuring the devices safety and effectiveness, particularly looking at 30-day all-cause mortality and key events up to 12 months after enrollment. The goal is to assess device technical success and the absence of serious complications related to the device or procedure. Participants will receive treatment through a thoracic endovascular repair TEVAR procedure using the Cratos Stent Graft. The study involves placing the stent graft in a specific area of the descending thoracic aorta, called Zone 2, with careful attention to the anatomical suitability of landing zones in the aorta and left subclavian artery. The procedure is minimally invasive and designed to repair the affected aortic lesions. There is only one study group receiving this active device treatment. During the study, participants will attend hospital visits at 1, 6, 12, 24, 36, 48, and 60 months after the procedure. Assessments will include physical examinations, neurological function scales such as the Modified Rankin scale and Tarlov scoring scale, and imaging tests like computed tomography angiography CTA. These evaluations will help researchers monitor the participants condition, device performance, and overall safety throughout the study period.

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