Trial Outcomes & Findings for An International Pulmonary Embolism Registry Using EKOS (NCT NCT03426124)

Last Updated: 2023-02-22

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

1480 participants

Primary outcome timeframe

Baseline to post-procedure (end of procedure through hospital discharge up to 14 days)

Results posted on

2023-02-22

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	991	489
Overall Study COMPLETED	941	251
Overall Study NOT COMPLETED	50	238

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An International Pulmonary Embolism Registry Using EKOS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Retrospective n=991 Participants 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.	Prospective n=489 Participants 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.	Total n=1480 Participants Total of all reporting groups
Age, Continuous	62.0 years n=5 Participants	63.0 years n=7 Participants	63.0 years n=5 Participants
Sex/Gender, Customized Male	486 Participants n=5 Participants	259 Participants n=7 Participants	745 Participants n=5 Participants
Sex/Gender, Customized Female	504 Participants n=5 Participants	230 Participants n=7 Participants	734 Participants n=5 Participants
Sex/Gender, Customized No Answer	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	652 Participants n=5 Participants	296 Participants n=7 Participants	948 Participants n=5 Participants
Race/Ethnicity, Customized African American	192 Participants n=5 Participants	77 Participants n=7 Participants	269 Participants n=5 Participants
Race/Ethnicity, Customized Other	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Missing	134 Participants n=5 Participants	117 Participants n=7 Participants	251 Participants n=5 Participants
Baseline Medical History Active Cancer	79 Participants n=5 Participants	20 Participants n=7 Participants	99 Participants n=5 Participants
Baseline Medical History BMI ≥30.0 kg/m²	642 Participants n=5 Participants	319 Participants n=7 Participants	961 Participants n=5 Participants
Baseline Medical History Family History of Venous Thromboembolism	109 Participants n=5 Participants	71 Participants n=7 Participants	180 Participants n=5 Participants
Baseline Medical History History of Cancer in Remission	116 Participants n=5 Participants	60 Participants n=7 Participants	176 Participants n=5 Participants
Baseline Medical History Congestive Heart Failure	54 Participants n=5 Participants	13 Participants n=7 Participants	67 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Retrospective n=276 Participants 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.	Prospective n=176 Participants 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.
Change in RV/LV Ratio on Echocardiogram (Matched Pairs as Available)	-22.6 Percent change Standard Deviation 20.8	-22.6 Percent change Standard Deviation 19.9

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Retrospective n=991 Participants 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.	Prospective n=489 Participants 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.
Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. Continuation of procedure beyond planned time/dose	7 Participants	1 Participants
Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. Surgical pulmonary embolectomy	0 Participants	1 Participants
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	2 Participants
Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. Peripherally administered systemic fibrinolytic therapy	4 Participants	0 Participants
Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. Other therapy/procedure	40 Participants	3 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Retrospective n=991 Participants 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.	Prospective n=489 Participants 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.
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	1 Participants
Number of Patients Who Underwent Interventional Therapies Prior to the APT Procedure and Experienced a Non- or Partial- Response. Surgical pulmonary embolectomy	5 Participants	0 Participants
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	0 Participants
Number of Patients Who Underwent Interventional Therapies Prior to the APT Procedure and Experienced a Non- or Partial- Response. Other	11 Participants	3 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Retrospective n=991 Participants 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.	Prospective n=489 Participants 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.
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	5 Participants
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	1 Participants
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	0 Participants

PRIMARY outcome

Timeframe: Start of procedure through 12 months post-procedure.

Population: Retrospective data to be updated.

Number of all-cause mortality that occurred from the start of procedure through 12 months post-procedure.

Outcome measures

Outcome measures
Measure	Retrospective n=991 Participants 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.	Prospective n=489 Participants 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.
All-cause Mortality During First 12 Months Post-procedure.	50 Participants	15 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Retrospective n=991 Participants 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.	Prospective n=483 Participants 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.
Healthcare Utilization	44.2 Hours Interval 27.3 to 64.6	41.2 Hours Interval 25.8 to 54.3

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	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.	Prospective n=243 Participants 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.
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
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 outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	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.	Prospective n=483 Participants 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.
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
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
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
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
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
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 outcome

Timeframe: From date of procedure through 12 months

Measured by number patients with an occurrence of needing an IVC filter placement.

Outcome measures

Outcome measures
Measure	Retrospective n=991 Participants 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.	Prospective n=483 Participants 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.
Number of Patients Needing an IVC Filter Placement	50 Participants	20 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Retrospective n=991 Participants 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.	Prospective n=489 Participants 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.
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	3 Participants
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	8 Participants
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	3 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Retrospective n=991 Participants 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.	Prospective n=489 Participants 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.
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	5 Participants
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	31 Participants
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	11 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Retrospective n=991 Participants 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.	Prospective n=489 Participants 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.
Diagnosis of Pulmonary Hypertension Diagnosis	0 Participants	1 Participants

Adverse Events

Retrospective

Serious events: 100 serious events

Other events: 63 other events

Deaths: 50 deaths

Prospective

Serious events: 39 serious events

Other events: 40 other events

Deaths: 15 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Retrospective n=991 participants at risk 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.	Prospective n=489 participants at risk 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.
Vascular disorders Deep Vein Thrombosis	3.9% 39/991 • Adverse Events were collected on or after the date of the procedure through 12 months. Data presented are for prospective and retrospective patients through the 12 month follow up visit. Only TEAEs (Treatment Emergent Adverse Event), defined as AEs starting on or after the date of intervention are included in this table. Patients are counted at most once for each preferred MedDRA term. Some patients were not followed for the full 12 months due to retrospective data collection and prospective data collection ending prior to the last patient reaching 12 months.	7.0% 34/489 • Adverse Events were collected on or after the date of the procedure through 12 months. Data presented are for prospective and retrospective patients through the 12 month follow up visit. Only TEAEs (Treatment Emergent Adverse Event), defined as AEs starting on or after the date of intervention are included in this table. Patients are counted at most once for each preferred MedDRA term. Some patients were not followed for the full 12 months due to retrospective data collection and prospective data collection ending prior to the last patient reaching 12 months.
Vascular disorders Haematoma	2.4% 24/991 • Adverse Events were collected on or after the date of the procedure through 12 months. Data presented are for prospective and retrospective patients through the 12 month follow up visit. Only TEAEs (Treatment Emergent Adverse Event), defined as AEs starting on or after the date of intervention are included in this table. Patients are counted at most once for each preferred MedDRA term. Some patients were not followed for the full 12 months due to retrospective data collection and prospective data collection ending prior to the last patient reaching 12 months.	1.2% 6/489 • Adverse Events were collected on or after the date of the procedure through 12 months. Data presented are for prospective and retrospective patients through the 12 month follow up visit. Only TEAEs (Treatment Emergent Adverse Event), defined as AEs starting on or after the date of intervention are included in this table. Patients are counted at most once for each preferred MedDRA term. Some patients were not followed for the full 12 months due to retrospective data collection and prospective data collection ending prior to the last patient reaching 12 months.

Additional Information

Leslie Cass

Boston Scientific

Phone: 206-641-4529

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place