Actively Recruiting
CRATOS - Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions
Led by Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd · Updated on 2025-02-26
130
Participants Needed
1
Research Sites
403 weeks
Total Duration
On this page
Sponsors
S
Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd
Lead Sponsor
Q
Qmed Consulting A/S
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
CRATOS - Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presence of thoracic aortic pathology (dissection including IMH and ULP; and PAU) requiring surgical repair with proximal graft placement in Zone 2
- Age 18 years or older at the time of informed consent
- Signed informed consent form by subject or legal representative
- Appropriate proximal aortic landing zone with inner diameters 23-41 mm, length at least 15 mm, no heavy calcification or thrombosis
- For dissection patients, primary entry tear must be distal to left subclavian artery (LSA), and proximal landing zone must not be dissected
- If prior replacement of ascending aorta or aortic arch, at least 2 cm landing zone proximal to most distal anastomosis site
- Appropriate LSA landing zone with inner diameters 5-14 mm, minimum length 25 mm, native aorta without severe tortuosity, aneurysm, dissection, heavy calcification, or thrombosis
- Appropriate distal aortic landing zone with inner diameters 18-44 mm, no heavy calcification or thrombosis
- For isolated PAU, outer curvature length at least 2 cm proximal to celiac artery
- Landing zones must be in native aorta
You will not qualify if you...
- Concomitant disease of ascending aorta or abdominal aortic aneurysm requiring repair
- Previous endovascular repair of ascending aorta
- Infected aorta or active systemic infection
- Surgery within 30 days prior to enrollment except vascular conduit placement for access
- Life expectancy less than 1 year
- Myocardial infarction within 6 weeks prior to treatment
- Stroke within 6 weeks prior to treatment
- Pregnant or breastfeeding females
- Active systemic infection requiring parenteral anti-infective treatment
- Degenerative connective tissue diseases such as Marfan's or Ehlers-Danlos Syndrome
- Participation in another drug or device study within 1 year of enrollment
- Known drug abuse within 1 year of treatment
- Tortuous or stenotic iliac or femoral arteries preventing device insertion without conduit
- Planned coverage of celiac artery
- Allergy to contrast agents, anesthetics, or delivery materials
- History of Heparin Induced Thrombocytopenia type 2 or known heparin hypersensitivity
- History of hypercoagulability disorder or current hypercoagulable state
- Persistent refractory shock with systolic blood pressure below 90 mm Hg
- Renal failure with estimated glomerular filtration rate below 30 or currently on dialysis
- Contraindications to antiplatelet drugs or anticoagulants
- Investigator judgment deeming patient unsuitable for interventional treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Zurich
Zurich, Switzerland
Actively Recruiting
Research Team
J
Jing Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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