Active — Not RecruitingNot Applicable

Aventus Thrombectomy System Pulmonary Embolism Clinical Study

United States130 participantsStarted 2023-09-20

Plain-language summary

Evaluate the safety and efficacy of the Aventus Thrombectomy System for aspiration thrombectomy in subjects with acute pulmonary embolism.

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥ 18 and ≤ 80 years
✓. Subject or legally authorized representative (LAR) is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures
✓. Subject is willing and able to comply with all protocol required follow-up visits
✓. PE symptom(s) duration ≤ 14 days from index procedure
✓. PE diagnosis ≤ 48 hours prior to index procedure
✓. CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery based on Investigator determination)
✓. CTA evidence of dilated RV with an RV/LV ratio of ≥ 0.9 at baseline based on Investigator determination
✓. Systolic blood pressure ≥ 90 mmHg without need for vasopressors (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with intravenous fluids prior to index procedure)

✕. Prior PE ≤ 180 days from index procedure
✕. Current hospitalization for other condition(s)
✕. Thrombolytic use ≤ 14 days of baseline CTA
✕. Pulmonary hypertension with peak pulmonary artery systolic pressure \> 70 mmHg by right heart catheterization
✕. FiO2 requirement \> 40% or \> 6 LPM to keep oxygen saturation \> 90%
✕. Hematocrit \< 28% within 6 hours of index procedure
✕. Platelets \< 100,000/μL
✕. Serum creatinine \> 1.8 mg/dL

Change in RV/LV Ratio

Timeframe: From Baseline to 48 hours

Major Adverse Event Rate

Timeframe: From Index Procedure to 48 hours

NCT IDNCT05907564

SponsorInquis Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-20

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥ 18 and ≤ 80 years
✓. Subject or legally authorized representative (LAR) is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures
✓. Subject is willing and able to comply with all protocol required follow-up visits
✓. PE symptom(s) duration ≤ 14 days from index procedure
✓. PE diagnosis ≤ 48 hours prior to index procedure
✓. CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery based on Investigator determination)
✓. CTA evidence of dilated RV with an RV/LV ratio of ≥ 0.9 at baseline based on Investigator determination
✓. Systolic blood pressure ≥ 90 mmHg without need for vasopressors (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with intravenous fluids prior to index procedure)

✕. Prior PE ≤ 180 days from index procedure
✕. Current hospitalization for other condition(s)
✕. Thrombolytic use ≤ 14 days of baseline CTA
✕. Pulmonary hypertension with peak pulmonary artery systolic pressure \> 70 mmHg by right heart catheterization
✕. FiO2 requirement \> 40% or \> 6 LPM to keep oxygen saturation \> 90%
✕. Hematocrit \< 28% within 6 hours of index procedure
✕. Platelets \< 100,000/μL
✕. Serum creatinine \> 1.8 mg/dL