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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 2024 to Mar 8, 2024
    v3
  2. Primary completion date: Dec 2025 to Dec 2026
    • Start date: Oct 2023 to Mar 2024
    • Study completion date: Mar 2031 to Dec 2031
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT05874206
Lead Sponsor Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd
Collaborators: Qmed Consulting A/S
Conditions
(from sponsor)		 Aortic Dissection Type B, Intramural Hematoma, Penetrating Aortic Ulcer
Related terms Penetrating Atherosclerotic Ulcer
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov