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NCT05874206 | RECRUITING | Aortic Dissection Type B

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

Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd

Brief Summary:

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

Condition or disease

Aortic Dissection Type B

Intramural Hematoma

Penetrating Aortic Ulcer

Intervention/treatment

Cratos™ Stent Graft

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 130 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions
Actual Study Start Date : 2024-03-08
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2031-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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 legal representative
  • 4. Must have appropriate proximal aortic landing zone, defined as
    • * Landing zone inner diameters between 23-41 mm
    • * The length of landing zone ≥15mm
    • * Landing without heavily calcified or heavily thrombosed
    • * Dissection Patients: Primary entry tear must be distal to LSA, and proximal extent of the proximal landing zone must not be dissected.
    • * For patients with prior replacement of the ascending aorta and/or aortic arch by a surgical graft, there must be at least 2 cm of landing zone proximal to the most distal anastomosis site.
    • 5. Must have appropriate LSA landing zone, defined as
      • * Inner diameters of LSA 5-14 mm
      • * Minimum length of Left subclavian artery is 25 mm
      • * Target branch vessel landing zone must be in native aorta that cannot be severely tortuous , aneurysmal, dissected, heavily calcified, or heavily thrombosed.
      • 6. Must have appropriate distal aortic landing zone, defined as
        • * Aortic inner diameters between 18-44 mm
        • * Landing zone cannot be heavily calcified, or heavily thrombosed.
        • * For isolated PAU, outer curvature length must be ≥ 2cm proximal to the celiac artery
        • * Landing zone in native aorta
        Exclusion Criteria
        • 1. Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair
        • 2. Previous endovascular repair of the ascending aorta
        • 3. Infected aorta, active systemic infection
        • 4. Surgery within 30 days prior to enrolment with the exception of placement of vascular conduit for access .
        • 5. Life expectancy \<1 years
        • 6. Myocardial infarction within 6 weeks prior to treatment
        • 7. Stroke within 6 weeks prior to treatment.
        • 8. Pregnant or breastfeeding female
        • 9. Patient has an active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication) that may place the patient at increased risk of endovascular infection.
        • 10. Degenerative connective tissue disease, e.g., Marfan's or Ehlers-Danlos Syndrome
        • 11. Participation in another drug or medical device study within one year of study enrolment
        • 12. Known history of drug abuse within one year of treatment
        • 13. Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access
        • 14. Planned coverage of celiac artery
        • 15. Allergic to contrast agents, anaesthetics and delivery materials
        • 16. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
        • 17. Patient with a history of a hypercoagulability disorder and/or is currently in a hypercoagulability state
        • 18. Persistent refractory shock (systolic blood pressure \<90 mm Hg)
        • 19. Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) \<30 (ml/min/1.73 m2) or currently requiring dialysis
        • 20. Contraindications to antiplatelet drugs and anticoagulants
        • 21. Investigator judged that not suitable for interventional treatment.
CRATOS - Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions

Location Details

NCT05874206

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Locations

RECRUITING

Switzerland,

University Hospital Zurich

Zurich, Switzerland,