Trial Outcomes & Findings for Multicenter, Nonrandomized, Prospective Study of Pulmonary Embolism Removal With the AngioJet 6F Ultra System (NCT NCT01638468)

Results Overview

The change in the subannular end-diastolic RV/LV ratio at 24-48 hrs following thrombectomy compared to baseline measurements as assessed by an independent core lab analysis. RV and LV values will be measured by echocardiography, a technique utilizing ultrasound waves to assess heart activity.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

7 participants

Primary outcome timeframe

Baseline to 24-48 hours

Results posted on

2018-12-05

Participant Flow

Participant milestones

Participant milestones
Measure	AngioJet Ultra PE Thrombectomy System Patients are treated with the AngioJet Ultra PE Thrombectomy System AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multicenter, Nonrandomized, Prospective Study of Pulmonary Embolism Removal With the AngioJet 6F Ultra System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AngioJet Ultra PE Thrombectomy System n=7 Participants Patients are treated with the AngioJet Ultra PE Thrombectomy System AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System
Age, Continuous	62.3 years STANDARD_DEVIATION 8.0 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment Italy	4 participants n=5 Participants
Region of Enrollment Switzerland	1 participants n=5 Participants
Region of Enrollment Portugal	2 participants n=5 Participants
Body Mass Index (BMI)	28.33 kg/m2 STANDARD_DEVIATION 4.43 • n=5 Participants
Height	170.0 cm STANDARD_DEVIATION 12.6 • n=5 Participants
Weight	82.6 kg STANDARD_DEVIATION 19.5 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 24-48 hours

Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint

The change in the subannular end-diastolic RV/LV ratio at 24-48 hrs following thrombectomy compared to baseline measurements as assessed by an independent core lab analysis. RV and LV values will be measured by echocardiography, a technique utilizing ultrasound waves to assess heart activity.

Outcome measures

Outcome measures
Measure	AngioJet Ultra PE Thrombectomy System n=7 Participants Patients are treated with the AngioJet Ultra PE Thrombectomy System AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System
Change in Right Ventricular (RV) to Left Ventricular (LV) Ratio at 24 - 48 Hours as Measured by Echocardiography	-0.610 ratio Standard Deviation 0.125

SECONDARY outcome

Timeframe: Index Procedure

Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint

Percentage of patients with successful placement and operation of the AngioJet catheter in the pulmonary arteries during the index procedure

Outcome measures

Outcome measures
Measure	AngioJet Ultra PE Thrombectomy System n=7 Participants Patients are treated with the AngioJet Ultra PE Thrombectomy System AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System
Technical Success	100 percentage of participants

SECONDARY outcome

Timeframe: 3 months

Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint

Number of participant deaths due to any reason occurring within 3 months of the index procedure.

Outcome measures

Outcome measures
Measure	AngioJet Ultra PE Thrombectomy System n=7 Participants Patients are treated with the AngioJet Ultra PE Thrombectomy System AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System
Death - All Cause	1 participants

SECONDARY outcome

Timeframe: 3 months

Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint

Number of participant deaths due to cardiac causes occurring within 3 months of the index procedure.

Outcome measures

Outcome measures
Measure	AngioJet Ultra PE Thrombectomy System n=7 Participants Patients are treated with the AngioJet Ultra PE Thrombectomy System AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System
Death - Cardiac Cause	0 participants

SECONDARY outcome

Timeframe: Baseline to Post Index Procedure

Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 1 participant was not evaluable.

Change in systolic pulmonary arterial blood pressure at termination of the index procedure as compared to the pre-procedure assessment.

Outcome measures

Outcome measures
Measure	AngioJet Ultra PE Thrombectomy System n=6 Participants Patients are treated with the AngioJet Ultra PE Thrombectomy System AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System
Change in Systolic Pulmonary Arterial Blood Pressure	-8.3 mmHg Standard Deviation 11.8

SECONDARY outcome

Timeframe: Post Index Procedure

Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 1 participants were not evaluable.

Pulmonary systolic arterial blood pressure at termination of the index procedure.

Outcome measures

Outcome measures
Measure	AngioJet Ultra PE Thrombectomy System n=6 Participants Patients are treated with the AngioJet Ultra PE Thrombectomy System AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System
Pulmonary Systolic Arterial Blood Pressure	44.2 mmHg Standard Deviation 11.3

SECONDARY outcome

Timeframe: Baseline to Post Index Procedure

Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint

Change in systemic systolic arterial blood pressure at termination of the index procedure as compared to the pre-procedure assessment.

Outcome measures

Outcome measures
Measure	AngioJet Ultra PE Thrombectomy System n=7 Participants Patients are treated with the AngioJet Ultra PE Thrombectomy System AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System
Change in Systemic Systolic Arterial Blood Pressure	14.7 mmHg Standard Deviation 22.1

SECONDARY outcome

Timeframe: Post Index Procedure

Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint.

Systemic systolic arterial blood pressure at termination of the index procedure.

Outcome measures

Outcome measures
Measure	AngioJet Ultra PE Thrombectomy System n=7 Participants Patients are treated with the AngioJet Ultra PE Thrombectomy System AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System
Systemic Systolic Arterial Blood Pressure	136.0 mmHg Standard Deviation 18.5

SECONDARY outcome

Timeframe: Baseline to Post Index Procedure

Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 2 participants were not evaluable.

Change in heart rate at termination of the index procedure as compared to the pre-procedure assessment.

Outcome measures

Outcome measures
Measure	AngioJet Ultra PE Thrombectomy System n=5 Participants Patients are treated with the AngioJet Ultra PE Thrombectomy System AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System
Change in Heart Rate	-12.2 beats per minute Standard Deviation 9.4

SECONDARY outcome

Timeframe: Index Procedure

Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint

Percentage of participants receiving vasopressor support during the index procedure. Vasopressor support are medications administered to prevent the narrowing of blood vessels.

Outcome measures

Outcome measures
Measure	AngioJet Ultra PE Thrombectomy System n=7 Participants Patients are treated with the AngioJet Ultra PE Thrombectomy System AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System
Vasopressor Support	0 percentage of participants

SECONDARY outcome

Timeframe: 3 months

Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint

Number of procedure related adverse events occurring within 3 months of the index procedure

Outcome measures

Outcome measures
Measure	AngioJet Ultra PE Thrombectomy System n=7 Participants Patients are treated with the AngioJet Ultra PE Thrombectomy System AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System
Procedure Related Adverse Event Rate	0 events

Adverse Events

AngioJet Ultra PE Thrombectomy System

Serious events: 4 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AngioJet Ultra PE Thrombectomy System n=7 participants at risk Patients are treated with the AngioJet Ultra PE Thrombectomy System AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism, Re-occurring	28.6% 2/7 • Number of events 2 • Adverse events were collected from the index procedure through the 3 month follow up visit.
Vascular disorders Death	14.3% 1/7 • Number of events 1 • Adverse events were collected from the index procedure through the 3 month follow up visit.
Gastrointestinal disorders Bowel Obstruction	14.3% 1/7 • Number of events 1 • Adverse events were collected from the index procedure through the 3 month follow up visit.
Renal and urinary disorders Macrohematuria (presence of blood cells in urine)	14.3% 1/7 • Number of events 1 • Adverse events were collected from the index procedure through the 3 month follow up visit.

Other adverse events

Other adverse events
Measure	AngioJet Ultra PE Thrombectomy System n=7 participants at risk Patients are treated with the AngioJet Ultra PE Thrombectomy System AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System
Respiratory, thoracic and mediastinal disorders Pneumonia	14.3% 1/7 • Number of events 1 • Adverse events were collected from the index procedure through the 3 month follow up visit.
General disorders Epistaxis (bleeding from the nose)	14.3% 1/7 • Number of events 1 • Adverse events were collected from the index procedure through the 3 month follow up visit.

Additional Information

Angela Schutt

Boston Scientific

Phone: 763-494-2166

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place