CLEANer Aspiration for Pulmonary Embolism

Evaluate the safety and efficacy of the CLEANER™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE)

• Prospective, multi-center, single-arm, open label pivotal IDE study
• Approximately 125 subjects will be screened for 105 enrolled at up to 15 investigational sites in the United States

• The primary effectiveness endpoint is defined as a change in RV/LV ratio at 48 hours post-procedure (± 8 hours) assessed by CTA.
• The primary safety endpoint is a composite of major adverse events occurring within 48 hours of the procedure:
  • Device-related death
  • Major bleeding
  • Device-related SAEs, including:
    • Clinical deterioration
    • Pulmonary vascular injury
    • Cardiac injury

Subjects will be followed for 30 days (±7 days) post index procedure

Inclusion Criteria:

• Adults aged ≥18 with clinical signs of acute PE
• RV/LV ratio >0.9
• Systolic blood pressure ≥90 mmHg

Exclusion Criteria:

• tPA use within 14 days of baseline CTA
• Hemodynamic instability (systolic BP <90 mmHg for ≥15 minutes)
• Recent major trauma or surgery