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Acute Pulmonary Embolism Treatment With the AlphaVac Multipurpose Mechanical Aspiration System and the AlphaReturn Blood Management System: Evaluation of Safety and Effectiveness

Study acronym: APEX-Return
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study sites: 4 to 6v5
  2. Notable Recruitment opened
    • Primary and study completion pushed from Nov 2026 to Dec 2026
    • Study sites: 3 to 4
    • Start date changed from estimate of Mar 2026 to Mar 30, 2026
    v4
  3. Minor Study sites: 1 to 3v3
  4. Minor Study sites: 0 to 1v2
  5. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 investigation is intended to evaluate the safety and effectiveness of the AlphaReturn Blood Management System when used in conjunction with the cleared AlphaVac MMA F1885 System for the treatment of acute pulmonary embolism.
Trial Details
NCT Number NCT07280247
Lead Sponsor Angiodynamics, Inc.
Conditions
(from sponsor)
Pulmonary Embolism Acute
Related terms Pulmonary Embolism
Enrollment 39 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov