Pulmonary Embolism and Thrombosis
Conditions
Keywords
venous thromboembolism
Brief summary
This registry is designed to understand acoustic pulse thrombolysis (APT) treatment regimens used as standard of care globally for pulmonary embolism. The registry will include individuals who have already received the APT treatment and those that will undergo APT treatment.
Detailed description
For the prospective arm of the registry, a physician will have selected the APT procedure for the treatment of pulmonary embolism. The APT treatment and follow-up assessments are per clinical judgement and institutional standard of care which may vary at each clinical site. For the retrospective arm of the registry, the investigators will gather data from consecutive cases of individuals who received the APT treatment for pulmonary embolism. Specific baseline, treatment, and long-term health information is collected and de-identified.
Interventions
DEVICEEkoSonic Endovascular System with thrombolytic
The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.
Sponsors
BTG International Inc.
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Retrospective Inclusion Criteria: * Treated with APT procedure between January 1, 2014 and one year prior to site activation * RV/LV ≥ 1.0 from diagnostic computed tomographic angiography (CTA) or echocardiogram * PE symptom duration ≤ 14 days * Troponin elevation Retrospective
Exclusion criteria
* Enrollment into the OPTALYSE PE study Prospective Inclusion Criteria: * Male or female ≥ 18 years of age and ≤ 80 years of age * RV/LV ≥ 1.0 from diagnostic computed tomographic angiography (CTA) or echocardiogram * PE symptom duration ≤ 14 days * Troponin elevation * Signed informed consent obtained from participant or legally authorized representative * Investigator has selected the EKOS device to treat participant with massive or submassive pulmonary embolism Prospective
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in RV/LV Ratio on Echocardiogram (Matched Pairs as Available) | Baseline to post-procedure (end of procedure through hospital discharge up to 14 days) | Difference (percent change) in the measurement of the right ventricular to left ventricular diameters (RV/LV) ratio as measured on baseline echocardiogram to post-procedure echocardiogram (24-48 hours post initiation of therapy). |
| Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. | Post-procedure hospitalization through hospital discharge up to 14 days | Measured by number of subjects requiring interventions of adjunctive therapies received during post procedure hospitalization through hospital discharge up to 14 days. |
| Number of Patients Who Underwent Interventional Therapies Prior to the APT Procedure and Experienced a Non- or Partial- Response. | From date of enrollment up to or until the placement of the Ekos device, on average 48 hours. | Measured by number of patients who underwent interventional therapies prior to the APT procedure and experienced a non or partial response. |
| Number of Patients Experiencing a SAEs Related to EKOS Device and/or Procedure During First 12 Months Post-APT Procedure. | From time of APT procedure through 12 months post-procedure. | Number of subjects experiencing a SAE related to EKOS device and/or procedure from time of procedure through the first 12 months post-APT procedure, measured by frequency and severity of events. |
| All-cause Mortality During First 12 Months Post-procedure. | Start of procedure through 12 months post-procedure. | Number of all-cause mortality that occurred from the start of procedure through 12 months post-procedure. |
| Healthcare Utilization | Measured as time from ICU admission to ICU discharge in hours (from date of enrollment through 12 months post-procedure). | Summary of healthcare utilization from date of enrollment through discharge. |
| Change in Quality of Life (QOL) as Measured by the Pulmonary Embolism Quality of Life (PEmb-QOL) at the 3 Month and 12 Month Post-hospitalization Follow-up Visits | Measured as percent change in time from baseline assessment at discharge to 3 month and 12 month follow up. | Reported as percent change in the PEmb-QOL questionnaire score from baseline timepoint to 3 months and 12 months. The PEmb-QOL measures patient's quality of life following pulmonary embolism on a scale of 1 through 5, with lower scores indicating a better outcome. |
| Change in Quality of Life (QOL) as Measured by the EQ-5D-5L VAS, Utility and Misery Scores at the 3-month and 12-month Post-hospitalization Follow-up Visits. | Reported results include change from baseline to 3 months and 12 months post-procedure for prospective patients. | Reported as change in the VAS, Utility and Misery questionnaire scores from baseline timepoint and/or study visit to 3 months and 12 months. The VAS (Visual Analogue Scale) is a one question, unidimensional measure of pain intensity where a subject is asked to rate his pain on a scale of 100 through 1, with 100 indicating the best health imaginable through 1 indicating the worst health imaginable. Higher scores indicate a better outcome. The EQ-5D is a series of questions that measures Quality of Life on a scale of 0 through 5. 0 indicates no problems in daily activities and 5 indicates inability to perform daily activities. The total score is added up and compared to the total scale from 0 to 25, with 0 indicating no problems in daily activities and 25 indicating inability to perform daily activities. A lower score indicates a better outcome. |
| Number of Patients Needing an IVC Filter Placement | From date of procedure through 12 months | Measured by number patients with an occurrence of needing an IVC filter placement. |
| Number of Patients Experiencing Adverse Events Classified as Major Bleeding Events During First 12 Months Post-Procedure by Frequency and Severity | From post-procedure through 12-months post-procedure | Measured by number of patients experiencing adverse events related to major bleeding events from time of procedure through the first 12 months post-procedure by frequency and severity (mild, moderate, severe). |
| Number of Patients Experiencing VTE (Venus Thromboembolytic Events) During First 12 Months Post-Procedure by Frequency and Severity. | From post-procedure through 12-months post-procedure | Number of patients experiencing events related to VTE from time of procedure through the first 12 months post-procedure by frequency and severity. |
| Diagnosis of Pulmonary Hypertension Diagnosis | Analyzed 12 months post-procedure | New onset pulmonary hypertension defined as mean pulmonary artery pressure greater than 25 mm Hg by echocardiogram that persists at least 3 months after PE. |
Countries
Austria, France, Germany, Netherlands, Switzerland, Turkey (Türkiye), United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Retrospective Individuals with intermediate-high or high risk pulmonary embolism who were consecutively treated with the Ekosonic Endovascular System (EKOS) and thrombolytic drug between January 2014 and one year prior to site activation.
EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots. | 991 |
| Prospective Individuals who are experiencing intermediate-high or high risk pulmonary embolism where the treating investigator has selected the EKOS device and thrombolytic drug. The duration of ultrasound and volume of thrombolytic drug are selected per physician discretion.
EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots. | 489 |
| Total | 1,480 |
Baseline characteristics
| Characteristic | Retrospective | Prospective | Total |
|---|---|---|---|
| Age, Continuous | 62.0 years | 63.0 years | 63.0 years |
| Baseline Medical History Active Cancer | 79 Participants | 20 Participants | 99 Participants |
| Baseline Medical History BMI ≥30.0 kg/m² | 642 Participants | 319 Participants | 961 Participants |
| Baseline Medical History Congestive Heart Failure | 54 Participants | 13 Participants | 67 Participants |
| Baseline Medical History Family History of Venous Thromboembolism | 109 Participants | 71 Participants | 180 Participants |
| Baseline Medical History History of Cancer in Remission | 116 Participants | 60 Participants | 176 Participants |
| Race/Ethnicity, Customized African American | 192 Participants | 77 Participants | 269 Participants |
| Race/Ethnicity, Customized Caucasian | 652 Participants | 296 Participants | 948 Participants |
| Race/Ethnicity, Customized Other | 13 Participants | 9 Participants | 22 Participants |
| Race/Ethnicity, Customized Unknown or Missing | 134 Participants | 117 Participants | 251 Participants |
| Sex/Gender, Customized Female | 504 Participants | 230 Participants | 734 Participants |
| Sex/Gender, Customized Male | 486 Participants | 259 Participants | 745 Participants |
| Sex/Gender, Customized No Answer | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 50 / 991 | 15 / 489 |
| other Total, other adverse events | 63 / 991 | 40 / 489 |
| serious Total, serious adverse events | 100 / 991 | 39 / 489 |
Outcome results
Primary
All-cause Mortality During First 12 Months Post-procedure.
Number of all-cause mortality that occurred from the start of procedure through 12 months post-procedure.
Time frame: Start of procedure through 12 months post-procedure.
Population: Retrospective data to be updated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Retrospective | All-cause Mortality During First 12 Months Post-procedure. | 50 Participants |
| Prospective | All-cause Mortality During First 12 Months Post-procedure. | 15 Participants |
Primary
Change in Quality of Life (QOL) as Measured by the EQ-5D-5L VAS, Utility and Misery Scores at the 3-month and 12-month Post-hospitalization Follow-up Visits.
Reported as change in the VAS, Utility and Misery questionnaire scores from baseline timepoint and/or study visit to 3 months and 12 months. The VAS (Visual Analogue Scale) is a one question, unidimensional measure of pain intensity where a subject is asked to rate his pain on a scale of 100 through 1, with 100 indicating the best health imaginable through 1 indicating the worst health imaginable. Higher scores indicate a better outcome. The EQ-5D is a series of questions that measures Quality of Life on a scale of 0 through 5. 0 indicates no problems in daily activities and 5 indicates inability to perform daily activities. The total score is added up and compared to the total scale from 0 to 25, with 0 indicating no problems in daily activities and 25 indicating inability to perform daily activities. A lower score indicates a better outcome.
Time frame: Reported results include change from baseline to 3 months and 12 months post-procedure for prospective patients.
Population: Data for the retrospective cohort were not captured as Quality of Life questionnaires were not Standard of Care at most institutions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospective | Change in Quality of Life (QOL) as Measured by the EQ-5D-5L VAS, Utility and Misery Scores at the 3-month and 12-month Post-hospitalization Follow-up Visits. | Change in VAS at 12 Months | 11.1 units on a scale | Standard Deviation 21.7 |
| Prospective | Change in Quality of Life (QOL) as Measured by the EQ-5D-5L VAS, Utility and Misery Scores at the 3-month and 12-month Post-hospitalization Follow-up Visits. | Change in VAS at 3 Months | 12.4 units on a scale | Standard Deviation 24.36 |
| Prospective | Change in Quality of Life (QOL) as Measured by the EQ-5D-5L VAS, Utility and Misery Scores at the 3-month and 12-month Post-hospitalization Follow-up Visits. | Change in Utility Score at 3 Months | 0.20 units on a scale | Standard Deviation 0.35 |
| Prospective | Change in Quality of Life (QOL) as Measured by the EQ-5D-5L VAS, Utility and Misery Scores at the 3-month and 12-month Post-hospitalization Follow-up Visits. | Change in Utility Score at 12 Months | 0.19 units on a scale | Standard Deviation 0.31 |
| Prospective | Change in Quality of Life (QOL) as Measured by the EQ-5D-5L VAS, Utility and Misery Scores at the 3-month and 12-month Post-hospitalization Follow-up Visits. | Change in Misery Score at 3 Months | -2.8 units on a scale | Standard Deviation 4.8 |
| Prospective | Change in Quality of Life (QOL) as Measured by the EQ-5D-5L VAS, Utility and Misery Scores at the 3-month and 12-month Post-hospitalization Follow-up Visits. | Change in Misery Score at 12 Months | -2.7 units on a scale | Standard Deviation 4.3 |
Primary
Change in Quality of Life (QOL) as Measured by the Pulmonary Embolism Quality of Life (PEmb-QOL) at the 3 Month and 12 Month Post-hospitalization Follow-up Visits
Reported as percent change in the PEmb-QOL questionnaire score from baseline timepoint to 3 months and 12 months. The PEmb-QOL measures patient's quality of life following pulmonary embolism on a scale of 1 through 5, with lower scores indicating a better outcome.
Time frame: Measured as percent change in time from baseline assessment at discharge to 3 month and 12 month follow up.
Population: QOL date were not collected in the retrospective cohort. These questionnaires were only collected prospectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospective | Change in Quality of Life (QOL) as Measured by the Pulmonary Embolism Quality of Life (PEmb-QOL) at the 3 Month and 12 Month Post-hospitalization Follow-up Visits | PEmb-QOL Mean Change at 3 Months | -22.52 percentage change | Standard Deviation 24.12 |
| Prospective | Change in Quality of Life (QOL) as Measured by the Pulmonary Embolism Quality of Life (PEmb-QOL) at the 3 Month and 12 Month Post-hospitalization Follow-up Visits | PEmb-QOL Mean Change at 12 Months | -23.74 percentage change | Standard Deviation 24.14 |
Primary
Change in RV/LV Ratio on Echocardiogram (Matched Pairs as Available)
Difference (percent change) in the measurement of the right ventricular to left ventricular diameters (RV/LV) ratio as measured on baseline echocardiogram to post-procedure echocardiogram (24-48 hours post initiation of therapy).
Time frame: Baseline to post-procedure (end of procedure through hospital discharge up to 14 days)
Population: Subjects with matched pairs (pre-procedure echocardiogram and post-procedure echocardiogram through discharge from index hospitalization) have been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Retrospective | Change in RV/LV Ratio on Echocardiogram (Matched Pairs as Available) | -22.6 Percent change | Standard Deviation 20.8 |
| Prospective | Change in RV/LV Ratio on Echocardiogram (Matched Pairs as Available) | -22.6 Percent change | Standard Deviation 19.9 |
Primary
Diagnosis of Pulmonary Hypertension Diagnosis
New onset pulmonary hypertension defined as mean pulmonary artery pressure greater than 25 mm Hg by echocardiogram that persists at least 3 months after PE.
Time frame: Analyzed 12 months post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Retrospective | Diagnosis of Pulmonary Hypertension Diagnosis | 0 Participants |
| Prospective | Diagnosis of Pulmonary Hypertension Diagnosis | 1 Participants |
Primary
Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization.
Measured by number of subjects requiring interventions of adjunctive therapies received during post procedure hospitalization through hospital discharge up to 14 days.
Time frame: Post-procedure hospitalization through hospital discharge up to 14 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Retrospective | Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. | Surgical pulmonary embolectomy | 0 Participants |
| Retrospective | Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. | Peripherally administered systemic fibrinolytic therapy | 4 Participants |
| Retrospective | Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. | Catheter-assisted embolectomy including thrombus fragmentation or aspiration | 5 Participants |
| Retrospective | Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. | Other therapy/procedure | 40 Participants |
| Retrospective | Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. | Continuation of procedure beyond planned time/dose | 7 Participants |
| Prospective | Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. | Other therapy/procedure | 3 Participants |
| Prospective | Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. | Continuation of procedure beyond planned time/dose | 1 Participants |
| Prospective | Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. | Surgical pulmonary embolectomy | 1 Participants |
| Prospective | Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. | Catheter-assisted embolectomy including thrombus fragmentation or aspiration | 2 Participants |
| Prospective | Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. | Peripherally administered systemic fibrinolytic therapy | 0 Participants |
Primary
Healthcare Utilization
Summary of healthcare utilization from date of enrollment through discharge.
Time frame: Measured as time from ICU admission to ICU discharge in hours (from date of enrollment through 12 months post-procedure).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Retrospective | Healthcare Utilization | 44.2 Hours |
| Prospective | Healthcare Utilization | 41.2 Hours |
Primary
Number of Patients Experiencing Adverse Events Classified as Major Bleeding Events During First 12 Months Post-Procedure by Frequency and Severity
Measured by number of patients experiencing adverse events related to major bleeding events from time of procedure through the first 12 months post-procedure by frequency and severity (mild, moderate, severe).
Time frame: From post-procedure through 12-months post-procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Retrospective | Number of Patients Experiencing Adverse Events Classified as Major Bleeding Events During First 12 Months Post-Procedure by Frequency and Severity | Major Bleeds within 365 days - Mild | 10 Participants |
| Retrospective | Number of Patients Experiencing Adverse Events Classified as Major Bleeding Events During First 12 Months Post-Procedure by Frequency and Severity | Major Bleeds within 365 days - Moderate | 33 Participants |
| Retrospective | Number of Patients Experiencing Adverse Events Classified as Major Bleeding Events During First 12 Months Post-Procedure by Frequency and Severity | Major Bleeds within 365 days - Severe | 18 Participants |
| Prospective | Number of Patients Experiencing Adverse Events Classified as Major Bleeding Events During First 12 Months Post-Procedure by Frequency and Severity | Major Bleeds within 365 days - Mild | 3 Participants |
| Prospective | Number of Patients Experiencing Adverse Events Classified as Major Bleeding Events During First 12 Months Post-Procedure by Frequency and Severity | Major Bleeds within 365 days - Moderate | 8 Participants |
| Prospective | Number of Patients Experiencing Adverse Events Classified as Major Bleeding Events During First 12 Months Post-Procedure by Frequency and Severity | Major Bleeds within 365 days - Severe | 3 Participants |
Primary
Number of Patients Experiencing a SAEs Related to EKOS Device and/or Procedure During First 12 Months Post-APT Procedure.
Number of subjects experiencing a SAE related to EKOS device and/or procedure from time of procedure through the first 12 months post-APT procedure, measured by frequency and severity of events.
Time frame: From time of APT procedure through 12 months post-procedure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Retrospective | Number of Patients Experiencing a SAEs Related to EKOS Device and/or Procedure During First 12 Months Post-APT Procedure. | SAEs related to EKOS device and/or procedure - Severe | 9 Participants |
| Retrospective | Number of Patients Experiencing a SAEs Related to EKOS Device and/or Procedure During First 12 Months Post-APT Procedure. | SAEs related to EKOS device and/or procedure - Moderate | 6 Participants |
| Retrospective | Number of Patients Experiencing a SAEs Related to EKOS Device and/or Procedure During First 12 Months Post-APT Procedure. | SAEs related to EKOS device and/or procedure - Mild | 1 Participants |
| Prospective | Number of Patients Experiencing a SAEs Related to EKOS Device and/or Procedure During First 12 Months Post-APT Procedure. | SAEs related to EKOS device and/or procedure - Severe | 5 Participants |
| Prospective | Number of Patients Experiencing a SAEs Related to EKOS Device and/or Procedure During First 12 Months Post-APT Procedure. | SAEs related to EKOS device and/or procedure - Moderate | 1 Participants |
| Prospective | Number of Patients Experiencing a SAEs Related to EKOS Device and/or Procedure During First 12 Months Post-APT Procedure. | SAEs related to EKOS device and/or procedure - Mild | 0 Participants |
Primary
Number of Patients Experiencing VTE (Venus Thromboembolytic Events) During First 12 Months Post-Procedure by Frequency and Severity.
Number of patients experiencing events related to VTE from time of procedure through the first 12 months post-procedure by frequency and severity.
Time frame: From post-procedure through 12-months post-procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Retrospective | Number of Patients Experiencing VTE (Venus Thromboembolytic Events) During First 12 Months Post-Procedure by Frequency and Severity. | VTEs within 365 Days - Mild | 33 Participants |
| Retrospective | Number of Patients Experiencing VTE (Venus Thromboembolytic Events) During First 12 Months Post-Procedure by Frequency and Severity. | VTEs within 365 Days - Moderate | 15 Participants |
| Retrospective | Number of Patients Experiencing VTE (Venus Thromboembolytic Events) During First 12 Months Post-Procedure by Frequency and Severity. | VTEs within 365 Days - Severe | 15 Participants |
| Prospective | Number of Patients Experiencing VTE (Venus Thromboembolytic Events) During First 12 Months Post-Procedure by Frequency and Severity. | VTEs within 365 Days - Mild | 31 Participants |
| Prospective | Number of Patients Experiencing VTE (Venus Thromboembolytic Events) During First 12 Months Post-Procedure by Frequency and Severity. | VTEs within 365 Days - Moderate | 11 Participants |
| Prospective | Number of Patients Experiencing VTE (Venus Thromboembolytic Events) During First 12 Months Post-Procedure by Frequency and Severity. | VTEs within 365 Days - Severe | 5 Participants |
Primary
Number of Patients Needing an IVC Filter Placement
Measured by number patients with an occurrence of needing an IVC filter placement.
Time frame: From date of procedure through 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Retrospective | Number of Patients Needing an IVC Filter Placement | 50 Participants |
| Prospective | Number of Patients Needing an IVC Filter Placement | 20 Participants |
Primary
Number of Patients Who Underwent Interventional Therapies Prior to the APT Procedure and Experienced a Non- or Partial- Response.
Measured by number of patients who underwent interventional therapies prior to the APT procedure and experienced a non or partial response.
Time frame: From date of enrollment up to or until the placement of the Ekos device, on average 48 hours.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Retrospective | Number of Patients Who Underwent Interventional Therapies Prior to the APT Procedure and Experienced a Non- or Partial- Response. | Peripherally administered systemic fibrinolytic therapy | 9 Participants |
| Retrospective | Number of Patients Who Underwent Interventional Therapies Prior to the APT Procedure and Experienced a Non- or Partial- Response. | Surgical pulmonary embolectomy | 5 Participants |
| Retrospective | Number of Patients Who Underwent Interventional Therapies Prior to the APT Procedure and Experienced a Non- or Partial- Response. | Catheter-assisted embolectomy including fragmentation or aspiration | 19 Participants |
| Retrospective | Number of Patients Who Underwent Interventional Therapies Prior to the APT Procedure and Experienced a Non- or Partial- Response. | Other | 11 Participants |
| Prospective | Number of Patients Who Underwent Interventional Therapies Prior to the APT Procedure and Experienced a Non- or Partial- Response. | Other | 3 Participants |
| Prospective | Number of Patients Who Underwent Interventional Therapies Prior to the APT Procedure and Experienced a Non- or Partial- Response. | Peripherally administered systemic fibrinolytic therapy | 1 Participants |
| Prospective | Number of Patients Who Underwent Interventional Therapies Prior to the APT Procedure and Experienced a Non- or Partial- Response. | Catheter-assisted embolectomy including fragmentation or aspiration | 0 Participants |
| Prospective | Number of Patients Who Underwent Interventional Therapies Prior to the APT Procedure and Experienced a Non- or Partial- Response. | Surgical pulmonary embolectomy | 0 Participants |