Actively Recruiting
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
260 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
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 device's 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 participant's condition, device performance, and overall safety throughout the study period.
CONDITIONS
Brief 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 intramural hematoma and ulcer-like projection, and penetrating aortic ulcer) needing surgical repair with proximal graft placement in Zone 2
- Age 18 years or older at time of informed consent
- Signed informed consent form by participant or legal representative
- Suitable proximal aortic landing zone with inner diameter 23-41 mm, length at least 15 mm, not heavily calcified or thrombosed
- For dissection patients, primary entry tear distal to left subclavian artery and proximal landing zone not dissected
- For prior ascending aorta or aortic arch graft replacement, at least 2 cm landing zone proximal to distal anastomosis
- Suitable left subclavian artery landing zone with inner diameter 5-14 mm and minimum length 25 mm
- Target branch vessel landing zone in native aorta without severe tortuosity, aneurysm, dissection, heavy calcification, or thrombosis
- Suitable distal aortic landing zone with inner diameter 18-44 mm, not heavily calcified or thrombosed
- For isolated penetrating aortic ulcer, outer curvature length at least 2 cm proximal to celiac artery
- Landing zones must be in native aorta
You will not qualify if you...
- Disease of ascending aorta or abdominal aortic aneurysm needing repair
- Previous endovascular repair of ascending aorta
- Infected aorta or active systemic infection
- Surgery within 30 days before enrollment except vascular conduit placement
- Life expectancy less than 1 year
- Myocardial infarction within 6 weeks prior to treatment
- Stroke within 6 weeks prior to treatment
- Pregnant or breastfeeding female
- Active systemic infection requiring parenteral treatment
- Degenerative connective tissue diseases such as Marfan's or Ehlers-Danlos syndrome
- Participation in another drug or device study within one year
- Drug abuse history within one year
- Tortuous or stenotic iliac or femoral arteries preventing device insertion
- Planned coverage of celiac artery
- Allergy to contrast agents, anesthetics, or delivery materials
- History of heparin-induced thrombocytopenia type 2 or heparin hypersensitivity
- History of hypercoagulability or current hypercoagulable state
- Persistent refractory shock with systolic blood pressure below 90 mm Hg
- Renal failure with eGFR below 30 or dialysis
- Contraindications to antiplatelet or anticoagulant drugs
- Investigator judgment of unsuitability for interventional treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants undergo the Cratos™ Stent Graft TEVAR procedure for the treatment of aortic lesions.
1 procedure visit (in-person)
Duration - 30 days
Participants are monitored after the procedure to assess recovery and safety outcomes.
Approximately 3 follow-up visits (in-person)
Trial Site Locations
Total: 1 location
1
University Hospital Zurich
Zurich, Switzerland
Actively Recruiting
Research Team
J
Jing Wang
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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