Aventus Thrombectomy System Pulmonary Embolism Clinical Study

• ClinicalTrials.gov Identifier: NCT05907564
• Recruitment Status: Recruiting
• First Posted: June 18, 2023
• Last Update Posted: April 4, 2024
• Sponsor: Inquis Medical, Inc.
• Information provided by (Responsible Party): Inquis Medical, Inc.

Tracking Information

• First Submitted Date: June 8, 2023
• First Posted Date: June 18, 2023
• Last Update Posted Date: April 4, 2024
• Actual Study Start Date: September 20, 2023
• Estimated Primary Completion Date: March 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 5, 2023)

• Change in RV/LV Ratio [ Time Frame: From Baseline to 48 hours ]
  Change in RV/LV Ratio per CTA
• Major Adverse Event Rate [ Time Frame: From Index Procedure to 48 hours ]
  Composite of device related MAEs including death, major bleed, clinical deterioration, pulmonary vascular injury, and cardiac injury

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Aventus Thrombectomy System Pulmonary Embolism Clinical Study
• Official Title: Evaluate the Safety and Efficacy of the Aventus Thrombectomy System for Aspiration Thrombectomy in Subjects With Acute Pulmonary Embolism
• Brief Summary: Evaluate the safety and efficacy of the Aventus Thrombectomy System for aspiration thrombectomy in subjects with acute pulmonary embolism.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Pulmonary Embolism
• Embolism
• Embolism and Thrombosis
• Vascular Diseases
• Cardiovascular Diseases
• Lung Diseases
• Respiratory Tract Diseases

Intervention

Device: Thrombectomy

Use of Aventus Thrombectomy System to treat pulmonary embolism

Study Arms

Experimental: Single Arm

Device: Aventus Thrombectomy System

Intervention: Device: Thrombectomy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 5, 2023): 120
• Original Enrollment: Not Provided
• Estimated Study Completion Date: March 2025
• Estimated Primary Completion Date: March 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Age ≥ 18 and ≤ 80 years
2. 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
3. Subject is willing and able to comply with all protocol required follow-up visits
4. PE symptom(s) duration ≤ 14 days from index procedure
5. PE diagnosis ≤ 48 hours prior to index procedure
6. CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery based on Investigator determination)
7. CTA evidence of dilated RV with an RV/LV ratio of ≥ 0.9 at baseline based on Investigator determination
8. 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)
9. Stable heart rate < 130 BPM prior to index procedure
10. Subject is deemed medically eligible for interventional procedure(s), per institutional guidelines and clinical judgment

Exclusion Criteria:

1. Prior PE ≤ 180 days from index procedure
2. Current hospitalization for other condition(s)
3. Thrombolytic use ≤ 14 days of baseline CTA
4. Pulmonary hypertension with peak pulmonary artery systolic pressure > 70 mmHg by right heart catheterization
5. FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%
6. Hematocrit < 28% within 6 hours of index procedure
7. Platelets < 100,000/μL
8. Serum creatinine > 1.8 mg/dL
9. International normalized ratio (INR) > 3
10. Presence of intracardiac lead in the right ventricle or right atrium placed < 180 days prior to index procedure
11. Cardiovascular or pulmonary surgery ≤ 7 days prior to index procedure
12. Actively progressing cancer treated by chemotherapeutics
13. Known bleeding diathesis or coagulation disorder
14. Left bundle branch block
15. History of severe or chronic pulmonary arterial hypertension
16. History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
17. History of uncompensated heart failure
18. History of underlying lung disease that is oxygen dependent
19. History of chest irradiation
20. History of heparin-induced thrombocytopenia (HIT)
21. Any contraindication to systemic or therapeutic doses of heparin or anticoagulants
22. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
23. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for aspiration thrombectomy intervention such as the inability to navigate to target location, predominantly chronic clot or non-clot embolus
24. Life expectancy of < 90 days, as determined by Investigator
25. Female who is pregnant or nursing
26. Current participation in another investigational drug or device treatment study that has not reached the primary endpoint or the Investigator feels would impact their ability to participate in this clinical trial
27. Subject has known residual Iliac Deep Vein Thrombosis (DVT), Inferior Vena Cava (IVC) clot or clot in transit (right atrium and/or right ventricular)
28. Subject on extracorporeal membrane oxygenation (ECMO)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Marc Penna; 978-760-0311; clinical@inquismedical.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05907564
• Other Study ID Numbers: CT-0001
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Inquis Medical, Inc.
• Original Responsible Party: [Redacted]
• Current Study Sponsor: Inquis Medical, Inc.
• Original Study Sponsor: [Redacted]
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jun Li, MD; University Hospitals
• Principal Investigator: Saher Sabri, MD; MedStar Health

• PRS Account: Inquis Medical, Inc.
• Verification Date: April 2024