Trial Outcomes & Findings for SYMPHONY-PE Study for Treatment of Pulmonary Embolism (NCT NCT06062329)
NCT ID: NCT06062329
Last Updated: 2026-08-10
Results Overview
A composite of all-cause major bleeding, device-related mortality, device-related serious adverse events
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
110 participants
Primary outcome timeframe
48 hours
Results posted on
2026-08-10
Participant Flow
A total of 684 patients were screened, 110 consented and 109 subjects enrolled across 17 centers in the United States.
Participant milestones
| Measure |
Symphony Thrombectomy System
Mechanical thrombectomy using the Symphony Thrombectomy System for the treatment of acute pulmonary embolism.
|
|---|---|
|
Overall Study
STARTED
|
109
|
|
Overall Study
COMPLETED
|
109
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SYMPHONY-PE Study for Treatment of Pulmonary Embolism
Baseline characteristics by cohort
| Measure |
Symphony Thrombectomy System
n=109 Participants
Mechanical thrombectomy using the Symphony Thrombectomy System for the treatment of acute pulmonary embolism.
|
|---|---|
|
Age, Continuous
|
62 Years
n=54 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
99 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=54 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=54 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=54 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=54 Participants
|
|
History of deep vein thrombosis
|
41 Participants
n=54 Participants
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: Intent to Treat: All participants intended to receive mechanical thrombectomy using the Symphony Thrombectomy System for treatment of acute pulmonary embolism.
A composite of all-cause major bleeding, device-related mortality, device-related serious adverse events
Outcome measures
| Measure |
Symphony Thrombectomy System
n=109 Participants
Mechanical thrombectomy using the Symphony Thrombectomy System for the treatment of acute pulmonary embolism.
|
|---|---|
|
Rate of Major Adverse Events
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline to 48 hoursPopulation: modified Intent to Treat: All subjects in the Intent to Treat population who have no thrombolytics administered any time prior to the 48 hour follow-up.
Change in RV/LV ratio from baseline to 48 hours post procedure assessed by CT Angiography (CTA) and adjudicated by an independent core-lab
Outcome measures
| Measure |
Symphony Thrombectomy System
n=102 Participants
Mechanical thrombectomy using the Symphony Thrombectomy System for the treatment of acute pulmonary embolism.
|
|---|---|
|
Mean Reduction of RV/LV Ratio
|
0.44 Ratio
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: 48 HoursPopulation: Intent to Treat: All participants intended to receive mechanical thrombectomy using the Symphony Thrombectomy System for treatment of acute pulmonary embolism.
Evaluate rates of all-cause major bleeding, device-related mortality, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury
Outcome measures
| Measure |
Symphony Thrombectomy System
n=109 Participants
Mechanical thrombectomy using the Symphony Thrombectomy System for the treatment of acute pulmonary embolism.
|
|---|---|
|
Secondary Safety Endpoints: 48 Hours
All-cause major bleeding
|
1 Participants
|
|
Secondary Safety Endpoints: 48 Hours
Device-related mortality
|
0 Participants
|
|
Secondary Safety Endpoints: 48 Hours
Device-related clinical deterioration
|
0 Participants
|
|
Secondary Safety Endpoints: 48 Hours
Device-related pulmonary vascular injury
|
0 Participants
|
|
Secondary Safety Endpoints: 48 Hours
Device-related cardiac injury
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: Intent to Treat: All participants intended to receive mechanical thrombectomy using the Symphony Thrombectomy System for treatment of acute pulmonary embolism.
Evaluate rates of PE related mortality, All-cause mortality, Device-related SAEs and Symptomatic PE recurrence
Outcome measures
| Measure |
Symphony Thrombectomy System
n=109 Participants
Mechanical thrombectomy using the Symphony Thrombectomy System for the treatment of acute pulmonary embolism.
|
|---|---|
|
Secondary Safety Endpoints: 30 Days
PE-Related Mortality
|
0 Participants
|
|
Secondary Safety Endpoints: 30 Days
All-Cause Mortality
|
0 Participants
|
|
Secondary Safety Endpoints: 30 Days
Device-Related Serious Adverse Events
|
0 Participants
|
|
Secondary Safety Endpoints: 30 Days
Symptomatic PE Recurrence
|
3 Participants
|
Adverse Events
Symphony Thrombectomy System
Serious events: 12 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Symphony Thrombectomy System
n=109 participants at risk
Intent to Treat: All participants intended to receive mechanical thrombectomy using the Symphony Thrombectomy System for treatment of acute pulmonary embolism.
|
|---|---|
|
Vascular disorders
Pulmonary Embolism
|
3.7%
4/109 • Number of events 4 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.8%
2/109 • Number of events 2 • 30 days
|
|
Surgical and medical procedures
Hemorrhage or excessive blood loss
|
1.8%
2/109 • Number of events 2 • 30 days
|
|
Vascular disorders
Pulmonary Injury
|
0.92%
1/109 • Number of events 1 • 30 days
|
|
Vascular disorders
Thrombosis
|
0.92%
1/109 • Number of events 1 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.92%
1/109 • Number of events 1 • 30 days
|
|
Cardiac disorders
Arrhythmia including ventricular fibrillation
|
0.92%
1/109 • Number of events 1 • 30 days
|
|
Infections and infestations
Infection
|
0.92%
1/109 • Number of events 1 • 30 days
|
|
Musculoskeletal and connective tissue disorders
Other - Fall secondary to osteoarthritis
|
0.92%
1/109 • Number of events 1 • 30 days
|
|
Renal and urinary disorders
Other - urinary tract infection
|
0.92%
1/109 • Number of events 1 • 30 days
|
|
Renal and urinary disorders
Other - obstructive renal stone
|
0.92%
1/109 • Number of events 1 • 30 days
|
Other adverse events
| Measure |
Symphony Thrombectomy System
n=109 participants at risk
Intent to Treat: All participants intended to receive mechanical thrombectomy using the Symphony Thrombectomy System for treatment of acute pulmonary embolism.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Worsening of bilateral pleural effusions
|
0.92%
1/109 • Number of events 1 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Transient Hypoxia
|
0.92%
1/109 • Number of events 1 • 30 days
|
|
Endocrine disorders
Hyperglycemia
|
0.92%
1/109 • Number of events 1 • 30 days
|
|
Renal and urinary disorders
Hypercalcemia
|
0.92%
1/109 • Number of events 1 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.92%
1/109 • Number of events 1 • 30 days
|
|
Cardiac disorders
Transient hypotension
|
0.92%
1/109 • Number of events 1 • 30 days
|
|
Renal and urinary disorders
Urinary retention
|
0.92%
1/109 • Number of events 1 • 30 days
|
|
Surgical and medical procedures
Hemorrhage or excessive blood loss
|
2.8%
3/109 • Number of events 3 • 30 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.8%
3/109 • Number of events 3 • 30 days
|
|
Blood and lymphatic system disorders
Anemia
|
1.8%
2/109 • Number of events 2 • 30 days
|
|
Cardiac disorders
Angina
|
1.8%
2/109 • Number of events 2 • 30 days
|
|
Skin and subcutaneous tissue disorders
Hematoma
|
1.8%
2/109 • Number of events 2 • 30 days
|
|
Cardiac disorders
Hypotension
|
1.8%
2/109 • Number of events 2 • 30 days
|
|
Cardiac disorders
Arrhythmia, including ventricular fibrillation
|
0.92%
1/109 • Number of events 1 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.92%
1/109 • Number of events 1 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.92%
1/109 • Number of events 1 • 30 days
|
|
Renal and urinary disorders
Rise in serum creatinine levels
|
0.92%
1/109 • Number of events 1 • 30 days
|
|
Infections and infestations
Leukocytosis
|
1.8%
2/109 • Number of events 2 • 30 days
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.92%
1/109 • Number of events 1 • 30 days
|
|
Cardiac disorders
Chest Pain
|
0.92%
1/109 • Number of events 1 • 30 days
|
|
General disorders
Groin Pain
|
0.92%
1/109 • Number of events 1 • 30 days
|
|
Musculoskeletal and connective tissue disorders
Left shoulder pain
|
0.92%
1/109 • Number of events 1 • 30 days
|
|
Renal and urinary disorders
Acute cystitis with hematuria
|
0.92%
1/109 • Number of events 1 • 30 days
|
|
Cardiac disorders
Cardiomyopathy
|
0.92%
1/109 • Number of events 1 • 30 days
|
|
Musculoskeletal and connective tissue disorders
Cervical Disc Herniation
|
0.92%
1/109 • Number of events 1 • 30 days
|
|
General disorders
Clot fever
|
0.92%
1/109 • Number of events 1 • 30 days
|
|
Cardiac disorders
Diastolic Heart Failure
|
0.92%
1/109 • Number of events 1 • 30 days
|
|
Metabolism and nutrition disorders
Elevated liver function
|
0.92%
1/109 • Number of events 1 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place