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SYMPHONY-PE Study for Treatment of Pulmonary Embolism

Primary Purpose

Acute Pulmonary Embolism, Thromboembolism, Emboli, Pulmonary

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Symphony Thrombectomy System
Sponsored by
Imperative Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pulmonary Embolism focused on measuring Thrombectomy, Submassive Pulmonary Embolism, Right Ventricle dysfunction

Eligibility Criteria

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

Inclusion Criteria: CTA evidence of acute PE within ≤14 days Clinical signs and symptoms consistent with acute PE. Systolic BP ≥90 mmHg with evidence of dilated RV with an RV/LV ratio >0.9 (based on Investigator's assessment of RV/LV ratio) Stable heart rate <130 BPM prior to procedure Subject is between 18 and 80 years of age Subject is willing to sign an IRB-approved informed consent form Subject is willing and able to comply with protocol follow-up Exclusion Criteria: Thrombolytic use within 14 days of baseline CTA International Normalized Ratio (INR) >3 Platelets <100,000/µL Kidney dysfunction as confirmed by serum creatinine >1.8 mg/dL or GFR <45 mL/min Hematocrit <28% or hemoglobin <9 g/dL Systolic BP <90 mmHg for 15 min or requirement of inotropic support to maintain systolic BP ≥90 mmHg any time after admission Experienced cardiac arrest Has left bundle branch block Known bleeding diathesis or coagulation disorder Presence of intracardiac lead in the right ventricle or right atrium Presence of intracardiac thrombus Major trauma within the past 14 days Cardiovascular or pulmonary surgery within last 7 days Known serious, uncontrolled sensitivity to radiographic agents Contraindication to anticoagulants, i.e., heparin or alternative Patient on extracorporeal membrane oxygenation (ECMO) Cancer requiring active chemotherapy Heparin-induced thrombocytopenia (HIT) Pulmonary hypertension with peak pulmonary artery pressure >70 mmHg by right heart catheterization. History of chronic severe pulmonary hypertension, and/or chronic left heart disease with left ventricular ejection fraction ≤30% Life expectancy <90 days as determined by investigator Pregnant or nursing COVID-19 positive at hospital admission Current participation in another investigational study Evidence such as imaging or other that suggests the subject is not appropriate for this procedure (e.g., target vessel size is too small to accommodate 16F or 24F catheters).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Symphony Thrombectomy system

    Arm Description

    Mechanical thrombectomy using the Symphony Thrombectomy system for the treatment of acute pulmonary embolism.

    Outcomes

    Primary Outcome Measures

    Primary Safety Endpoint
    Rate of major adverse events
    Primary Efficacy Endpoint
    Mean reduction of RV/LV ratio from baseline to 48 hours post procedure assessed by CT Angiography and adjudicated by an independent Core-lab

    Secondary Outcome Measures

    Secondary Safety Endpoints 1
    Rates of Major bleeding, Device-related mortality, Device-related clinical deterioration, Device-related pulmonary vascular injury and Device-related cardiac injury
    Secondary Safety Endpoints 2
    Rates of PE related mortality, All-cause mortality, Device-related SAEs and Symptomatic PE recurrence

    Full Information

    First Posted
    September 25, 2023
    Last Updated
    September 25, 2023
    Sponsor
    Imperative Care, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06062329
    Brief Title
    SYMPHONY-PE Study for Treatment of Pulmonary Embolism
    Official Title
    Evaluation of the Safety and Efficacy of the Symphony Thrombectomy System in the Treatment of Pulmonary Embolism
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    March 2025 (Anticipated)
    Study Completion Date
    April 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Imperative Care, 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
    Evaluation of the Safety and Efficacy of the Symphony Thrombectomy System in the Treatment of Pulmonary Embolism
    Detailed Description
    SYMPHONY-PE is a pivotal study intended to assess the safety and efficacy of the Symphony Thrombectomy System to treat subjects with acute pulmonary embolism.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Pulmonary Embolism, Thromboembolism, Emboli, Pulmonary, Thrombosis, Thrombus; Embolism, Embolism, Cardiovascular Diseases, Vascular Diseases
    Keywords
    Thrombectomy, Submassive Pulmonary Embolism, Right Ventricle dysfunction

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Symphony Thrombectomy system
    Arm Type
    Experimental
    Arm Description
    Mechanical thrombectomy using the Symphony Thrombectomy system for the treatment of acute pulmonary embolism.
    Intervention Type
    Device
    Intervention Name(s)
    Symphony Thrombectomy System
    Intervention Description
    The Symphony Thrombectomy System will be used to restore blood flow to the pulmonary arteries by removing thrombus/embolus/clot using aspiration and mechanical clot engagement.
    Primary Outcome Measure Information:
    Title
    Primary Safety Endpoint
    Description
    Rate of major adverse events
    Time Frame
    48 hours
    Title
    Primary Efficacy Endpoint
    Description
    Mean reduction of RV/LV ratio from baseline to 48 hours post procedure assessed by CT Angiography and adjudicated by an independent Core-lab
    Time Frame
    Baseline to 48 hours
    Secondary Outcome Measure Information:
    Title
    Secondary Safety Endpoints 1
    Description
    Rates of Major bleeding, Device-related mortality, Device-related clinical deterioration, Device-related pulmonary vascular injury and Device-related cardiac injury
    Time Frame
    48 Hours
    Title
    Secondary Safety Endpoints 2
    Description
    Rates of PE related mortality, All-cause mortality, Device-related SAEs and Symptomatic PE recurrence
    Time Frame
    30 Days

    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: CTA evidence of acute PE within ≤14 days Clinical signs and symptoms consistent with acute PE. Systolic BP ≥90 mmHg with evidence of dilated RV with an RV/LV ratio >0.9 (based on Investigator's assessment of RV/LV ratio) Stable heart rate <130 BPM prior to procedure Subject is between 18 and 80 years of age Subject is willing to sign an IRB-approved informed consent form Subject is willing and able to comply with protocol follow-up Exclusion Criteria: Thrombolytic use within 14 days of baseline CTA International Normalized Ratio (INR) >3 Platelets <100,000/µL Kidney dysfunction as confirmed by serum creatinine >1.8 mg/dL or GFR <45 mL/min Hematocrit <28% or hemoglobin <9 g/dL Systolic BP <90 mmHg for 15 min or requirement of inotropic support to maintain systolic BP ≥90 mmHg any time after admission Experienced cardiac arrest Has left bundle branch block Known bleeding diathesis or coagulation disorder Presence of intracardiac lead in the right ventricle or right atrium Presence of intracardiac thrombus Major trauma within the past 14 days Cardiovascular or pulmonary surgery within last 7 days Known serious, uncontrolled sensitivity to radiographic agents Contraindication to anticoagulants, i.e., heparin or alternative Patient on extracorporeal membrane oxygenation (ECMO) Cancer requiring active chemotherapy Heparin-induced thrombocytopenia (HIT) Pulmonary hypertension with peak pulmonary artery pressure >70 mmHg by right heart catheterization. History of chronic severe pulmonary hypertension, and/or chronic left heart disease with left ventricular ejection fraction ≤30% Life expectancy <90 days as determined by investigator Pregnant or nursing COVID-19 positive at hospital admission Current participation in another investigational study Evidence such as imaging or other that suggests the subject is not appropriate for this procedure (e.g., target vessel size is too small to accommodate 16F or 24F catheters).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sylvie Akiel-Fu, MPH
    Phone
    917-375-4735
    Email
    safu@imperativecare.com

    12. IPD Sharing Statement

    Learn more about this trial

    SYMPHONY-PE Study for Treatment of Pulmonary Embolism

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