Visit https://clinicaltrials.gov/study/NCT06189313 for more information. If you are a healthcare professional and want to learn more about this clinical trial, email clinical@argonmedical.com.
CLEANer Aspiration for Pulmonary Embolism
A study evaluating the safety and efficacy of the CLEANER™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE)
1
Objective
Evaluate the safety and efficacy of the CLEANER™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE)
2
Design
- 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
3
Primary Endpoints
- 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
4
Duration of Patient Follow-up
Subjects will be followed for 30 days (±7 days) post index procedure
5
Key Eligibility Criteria
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