Aventus Thrombectomy System Pulmonary Embolism Clinical Study

NCT05907564 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CT-0001
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 26

Brief Summary

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

Conditions

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

Keywords

Pulmonary Embolism; Clot; Thromboembolism; Thrombectomy; Right Heart Strain

Outcome Measures

Primary Outcomes (2)

• Change in RV/LV Ratio

  Change in RV/LV Ratio per CTA

  From Baseline to 48 hours

• 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

Study Arms (1)

Single Arm

EXPERIMENTAL

Device: Aventus Thrombectomy System

Device: Thrombectomy

Interventions

Thrombectomy DEVICE

Use of Aventus Thrombectomy System to treat pulmonary embolism

Single Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Stable heart rate \< 130 BPM prior to index procedure
• Subject is deemed medically eligible for interventional procedure(s), per institutional guidelines and clinical judgment

You may not qualify if:

• 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
• International normalized ratio (INR) \> 3
• Presence of intracardiac lead in the right ventricle or right atrium placed \< 180 days prior to index procedure
• Cardiovascular or pulmonary surgery ≤ 7 days prior to index procedure
• Actively progressing cancer treated by chemotherapeutics
• Known bleeding diathesis or coagulation disorder
• Left bundle branch block
• History of severe or chronic pulmonary arterial hypertension

Sponsors & Collaborators

• Inquis Medical, Inc.: lead

Study Sites (26)

Honor Health

Scottsdale, Arizona, 85258, United States

Location

NorthBay Medical Center

Fairfield, California, 94533, United States

Location

MemorialCare

Long Beach, California, 90806, United States

Location

El Camino Health

Mountain View, California, 94040, United States

Location

Sutter Health

Sacramento, California, 95816, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Medstar

Washington D.C., District of Columbia, 20010, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Alexian Brothers Medical Center

Elk Grove Village, Illinois, 60007, United States

Location

Ascension St. Vincent

Indianapolis, Indiana, 46260, United States

Location

Ochsner Health

New Orleans, Louisiana, 70121, United States

Location

McLaren Health Care

Bay City, Michigan, 48708, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Ascension Providence

Southfield, Michigan, 48075, United States

Location

CentraCare Heart and Vascular

Saint Cloud, Minnesota, 56303, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

Ichan School of Medicine at Mount Sinai

New York, New York, 10019, United States

Location

University Hospitals

Cleveland, Ohio, 44106, United States

Location

OhioHealth Research Institute

Columbus, Ohio, 43214, United States

Location

ProMedica - Jobst Vascular

Toledo, Ohio, 43606, United States

Location

Ascension St. John

Tulsa, Oklahoma, 74006, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Centennial Medical Center (HCA)

Nashville, Tennessee, 37203, United States

Location

Ascension Seton

Austin, Texas, 78705, United States

Location

MeSH Terms

Conditions

Pulmonary Embolism; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Thromboembolism

Interventions

Thrombectomy

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jun Li, MD

  University Hospitals

  PRINCIPAL INVESTIGATOR

• Saher Sabri, MD

  MedStar Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 18, 2023
• Study Start: September 20, 2023
• Primary Completion: February 20, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (26)