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Aventus Thrombectomy System Pulmonary Embolism Clinical Study

Primary Purpose

Pulmonary Embolism, Embolism, Embolism and Thrombosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thrombectomy
Sponsored by
Inquis Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism focused on measuring Pulmonary Embolism, Clot, Thromboembolism, Thrombectomy, Right Heart Strain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 History of chronic left heart disease with left ventricular ejection fraction ≤ 30% History of uncompensated heart failure History of underlying lung disease that is oxygen dependent History of chest irradiation History of heparin-induced thrombocytopenia (HIT) Any contraindication to systemic or therapeutic doses of heparin or anticoagulants Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated 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 Life expectancy of < 90 days, as determined by Investigator Female who is pregnant or nursing 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 Subject has known residual Iliac Deep Vein Thrombosis (DVT), Inferior Vena Cava (IVC) clot or clot in transit (right atrium and/or right ventricular) Subject on extracorporeal membrane oxygenation (ECMO)

Sites / Locations

  • MemorialCareRecruiting
  • University HospitalsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

Device: Aventus Thrombectomy System

Outcomes

Primary Outcome Measures

Change in RV/LV Ratio
Change in RV/LV Ratio per CTA
Major Adverse Event Rate
Composite of device related MAEs including death, major bleed, clinical deterioration, pulmonary vascular injury, and cardiac injury

Secondary Outcome Measures

Full Information

First Posted
June 8, 2023
Last Updated
October 20, 2023
Sponsor
Inquis Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05907564
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inquis Medical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism, Embolism, Embolism and Thrombosis, Vascular Diseases, Cardiovascular Diseases, Lung Diseases, Respiratory Tract Diseases
Keywords
Pulmonary Embolism, Clot, Thromboembolism, Thrombectomy, Right Heart Strain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Arm Description
Device: Aventus Thrombectomy System
Intervention Type
Device
Intervention Name(s)
Thrombectomy
Intervention Description
Use of Aventus Thrombectomy System to treat pulmonary embolism
Primary Outcome Measure Information:
Title
Change in RV/LV Ratio
Description
Change in RV/LV Ratio per CTA
Time Frame
From Baseline to 48 hours
Title
Major Adverse Event Rate
Description
Composite of device related MAEs including death, major bleed, clinical deterioration, pulmonary vascular injury, and cardiac injury
Time Frame
From Index Procedure to 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 History of chronic left heart disease with left ventricular ejection fraction ≤ 30% History of uncompensated heart failure History of underlying lung disease that is oxygen dependent History of chest irradiation History of heparin-induced thrombocytopenia (HIT) Any contraindication to systemic or therapeutic doses of heparin or anticoagulants Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated 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 Life expectancy of < 90 days, as determined by Investigator Female who is pregnant or nursing 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 Subject has known residual Iliac Deep Vein Thrombosis (DVT), Inferior Vena Cava (IVC) clot or clot in transit (right atrium and/or right ventricular) Subject on extracorporeal membrane oxygenation (ECMO)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc Penna
Phone
978-760-0311
Email
clinical@inquismedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Li, MD
Organizational Affiliation
University Hospitals
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Saher Sabri, MD
Organizational Affiliation
MedStar Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
MemorialCare
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Penna
Email
marc@inquismedical.com
First Name & Middle Initial & Last Name & Degree
Jessica Hobson
Email
jessica@inquismedical.com
First Name & Middle Initial & Last Name & Degree
David Shavelle, MD
Facility Name
University Hospitals
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Penna
Email
marc@inquismedical.com
First Name & Middle Initial & Last Name & Degree
Jessica Hobson
Email
jessica@inquismedical.com
First Name & Middle Initial & Last Name & Degree
Jun Li, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Aventus Thrombectomy System Pulmonary Embolism Clinical Study

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