SYMPHONY-PE Study for Treatment of Pulmonary Embolism

Sponsor

Imperative Care, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06062329

Collaborator

(none)

150

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Evaluation of the Safety and Efficacy of the Symphony Thrombectomy System in the Treatment of Pulmonary Embolism

Condition or Disease	Intervention/Treatment	Phase
Acute Pulmonary Embolism Thromboembolism Emboli, Pulmonary Thrombosis Thrombus; Embolism Embolism Cardiovascular Diseases Vascular Diseases	Device: Symphony Thrombectomy System	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluation of the Safety and Efficacy of the Symphony Thrombectomy System in the Treatment of Pulmonary Embolism

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Symphony Thrombectomy system Mechanical thrombectomy using the Symphony Thrombectomy system for the treatment of acute pulmonary embolism.	Device: Symphony Thrombectomy System 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.

Arm

Intervention/Treatment

Experimental: Symphony Thrombectomy system

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

Device: Symphony Thrombectomy System

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.

Outcome Measures

Primary Outcome Measures

Primary Safety Endpoint [48 hours]
Rate of major adverse events
Primary Efficacy Endpoint [Baseline to 48 hours]
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 [48 Hours]
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 [30 Days]
Rates of PE related mortality, All-cause mortality, Device-related SAEs and Symptomatic PE recurrence

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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).