Aventus Thrombectomy System Pulmonary Embolism Clinical Study

Cardiovascular Diseases Clinical Trial

Official title:

Evaluate the Safety and Efficacy of the Aventus Thrombectomy System for Aspiration Thrombectomy in Subjects With Acute Pulmonary Embolism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05907564
• Other study ID #: CT-0001
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2023
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Inquis Medical, Inc.
• Contact: Marc Penna
• Phone: 978-760-0311
• Email: clinical[@]inquismedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Device:
• Thrombectomy
Use of Aventus Thrombectomy System to treat pulmonary embolism

Locations

Country	Name	City	State
United States	Ascension Seton	Austin	Texas
United States	Northwestern University	Chicago	Illinois
United States	University Hospitals	Cleveland	Ohio
United States	OhioHealth Research Institute	Columbus	Ohio
United States	Alexian Brothers Medical Center	Elk Grove Village	Illinois
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Ascension St. Vincent	Indianapolis	Indiana
United States	MemorialCare	Long Beach	California
United States	Centennial Medical Center (HCA)	Nashville	Tennessee
United States	CentraCare Heart and Vascular	Saint Cloud	Minnesota
United States	Honor Health	Scottsdale	Arizona
United States	Ascension Providence	Southfield	Michigan
United States	Holy Name Medical Center	Teaneck	New Jersey
United States	ProMedica - Jobst Vascular	Toledo	Ohio
United States	Ascension St. John	Tulsa	Oklahoma
United States	Medstar	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Inquis Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in RV/LV Ratio	Change in RV/LV Ratio per CTA	From Baseline to 48 hours
Primary	Major Adverse Event Rate	Composite of device related MAEs including death, major bleed, clinical deterioration, pulmonary vascular injury, and cardiac injury	From Index Procedure to 48 hours