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NCT05874206 | Not yet 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

Not Applicable

Study Type : Interventional
Estimated Enrollment : 130 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions
Actual Study Start Date : March 2024
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2031
Arm Intervention/treatment

Experimental: attitude

Thoracic Endovascular Repair (TEVAR) provides a minimally invasive treatment option for descending thoracic aorta (DTA) pathologies.

Device: Cratos™ Stent Graft
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • 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
  • Age ≥18 years at time of informed consent signature
  • Informed Consent Form (ICF) is signed by Subject or legal representative
  • 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.
    • 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.
      • 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
        • Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair
        • Previous endovascular repair of the ascending aorta
        • Infected aorta, active systemic infection
        • Surgery within 30 days prior to enrolment with the exception of placement of vascular conduit for access .
        • Life expectancy <1 years
        • Myocardial infarction within 6 weeks prior to treatment
        • Stroke within 6 weeks prior to treatment.
        • Pregnant or breastfeeding female
        • 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.
        • Degenerative connective tissue disease, e.g., Marfan's or Ehlers-Danlos Syndrome
        • Participation in another drug or medical device study within one year of study enrolment
        • Known history of drug abuse within one year of treatment
        • Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access
        • Planned coverage of celiac artery
        • Allergic to contrast agents, anaesthetics and delivery materials
        • Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
        • Patient with a history of a hypercoagulability disorder and/or is currently in a hypercoagulability state
        • Persistent refractory shock (systolic blood pressure <90 mm Hg)
        • Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) <30 (ml/min/1.73 m2) or currently requiring dialysis
        • Contraindications to antiplatelet drugs and anticoagulants
        • Investigator judged that not suitable for interventional treatment.
CRATOS - Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions

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

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