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A Clinical Investigational Study of Ankura™ II AAA, IE and AE Stent Graft System for Endovascular Treatment of Abdominal Aortic Aneurysm

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Recruitment opened
    • Site details revised
    v4
  2. Primary completion moved earlier from Dec 30, 2032 to Dec 30, 2028
    • Study completion pushed from May 30, 2033 to Jun 30, 2033
    • Site contact updated
    v3
  3. Primary completion date: Dec 30, 2032 to Dec 30, 2028v2 Show 5 more changesShow less
    • Study sites: 2 to 1
    • Study completion date: May 30, 2033 to Jun 30, 2033
    • Interventions: AnkuraTM II Abdominal Aortic Stent Graft System (Device), Ankura™ II Abdominal Aortic Stent Graft System (Device) to Ankura™ II Abdominal Aortic Stent Graft System (Device)
    • Secondary endpoints: 11 to 12
    • Study title revised
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 objective of this clinical investigational study is to evaluate the safety and efficacy of the Ankura™ II AAA, AE Stent Graft System and the large-size Ankura™ II IE Stent Graft System (i.e., IE stent grafts with distal diameters of 24, 26, and 28 mm) for endovascular treatment of abdominal aortic aneurysm in patients with infrarenal abdominal aortic aneurysm who are suitable for endovascular intervention. The primary safety endpoint is the incidence of major adverse events within 30 days after the procedure. The primary efficacy endpoint is the 12-month treatment success rate.
Trial Details
NCT Number NCT07754240
Lead Sponsor Lifetech Scientific (Shenzhen) Co., Ltd.
Conditions
(from sponsor)		 Abdominal Aortic Aneurysms (AAA)
Related terms Aortic Aneurysm, Abdominal
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov