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

Recruiting N/A Interventional Study
Aortic Dissection Type B Intramural Hematoma Penetrating Aortic Ulcer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
130 (estimated)
Sponsor
Shanghai MicroPort Endovascular MedTech(Group)Co., Ltd · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. 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 2. Age ≥18 years at time of informed consent signature 3. Informed Consent Form (ICF) is signed by Subject or…
Contacts

Jing Wang

3105283618

jing.wang@endovastec.com

CONTACT