Pulmonary Embolism
Conditions
Keywords
Pulmonary Embolism, Acute Pulmonary Embolism, Sub-massive Pulmonary Embolism, Massive Pulmonary Embolism, Pulmonary Thromboembolism
Brief summary
The purpose of this European Post Market Follow-up Plan is designed to evaluate the safety, efficacy, adverse events and any new information that may surface regarding the use of the AngioJet Ultra PE Thrombectomy Catheter System in patients with thrombus in the main pulmonary and lobar arteries ≥ 6mm in diameter.
Detailed description
Despite advances in prophylaxis, diagnostic modalities, and therapeutic options, pulmonary embolism remains a commonly under diagnosed and lethal entity. In the United States approximately 150,000 patients per year are diagnosed with acute pulmonary embolisms. Many additional deaths occur each year in the United States as a result of undiagnosed massive pulmonary embolisms. Taking these patients into account, it is thought that up to 600,000 patients develop a pulmonary embolism annually in this country. In patients with acute pulmonary embolism, the most common cause of early death is right ventricular failure. In addition to anticoagulation therapy, several reperfusion therapies are being used to reverse right ventricular failure: systemic thrombolysis, surgical embolectomy, and catheter based therapy. Given the drawbacks of systemic thrombolytic therapy or surgical embolectomy, percutaneous catheter treatment is a reasonable alternative for patients with contraindications to systemic thrombolytic therapy or surgery. Current international consensus guidelines support the use of catheter interventions for selected pulmonary embolism patients at increased risk of adverse clinical outcomes. The AngioJet Ultra PE Thrombectomy catheter introduces a pressurized high velocity saline stream through a catheter tip so that the clot within a blood vessel is trapped, broken into small pieces and aspirated from the body.
Interventions
DEVICEAngioJet Ultra PE Thrombectomy System
Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Symptomatic pulmonary embolism patients \>18 years 2. Availability of a baseline contrast-enhanced chest computed tomogram or conventional pulmonary angiogram with evidence of pulmonary embolus in at least one main or lobar pulmonary artery ≥ 6mm in diameter 3. Availability of a baseline transthoracic echocardiogram with sufficient image quality permitting the measurement of right ventricular (RV) and left ventricular (LV) dimensions in the apical or subcostal four-chamber view 4. Echocardiographic evidence of right ventricular dilatation with a subannular RV/LV ratio ≥ 0.9 from the apical or subcostal four-chamber view 5. Appropriate informed consent was obtained from the patient or legal representative
Exclusion criteria
1. Patient has underwent Cardiopulmonary Resuscitation (CPR) in the last 48 hours 2. Patient is participating in any other clinical study 3. Pregnancy, lactation or parturition within the previous 30 days (positive pregnancy test, women of childbearing age must be tested or use a medically accepted method of birth control) 4. Inability to comply with study Follow-up assessments (e.g. due to geographic) 5. Previous enrollment in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Right Ventricular (RV) to Left Ventricular (LV) Ratio at 24 - 48 Hours as Measured by Echocardiography | Baseline to 24-48 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death - All Cause | 3 months | Number of participant deaths due to any reason occurring within 3 months of the index procedure. |
| Death - Cardiac Cause | 3 months | Number of participant deaths due to cardiac causes occurring within 3 months of the index procedure. |
| Change in Systolic Pulmonary Arterial Blood Pressure | Baseline to Post Index Procedure | Change in systolic pulmonary arterial blood pressure at termination of the index procedure as compared to the pre-procedure assessment. |
| Pulmonary Systolic Arterial Blood Pressure | Post Index Procedure | Pulmonary systolic arterial blood pressure at termination of the index procedure. |
| Technical Success | Index Procedure | Percentage of patients with successful placement and operation of the AngioJet catheter in the pulmonary arteries during the index procedure |
| Systemic Systolic Arterial Blood Pressure | Post Index Procedure | Systemic systolic arterial blood pressure at termination of the index procedure. |
| Change in Heart Rate | Baseline to Post Index Procedure | Change in heart rate at termination of the index procedure as compared to the pre-procedure assessment. |
| Vasopressor Support | Index Procedure | Percentage of participants receiving vasopressor support during the index procedure. Vasopressor support are medications administered to prevent the narrowing of blood vessels. |
| Procedure Related Adverse Event Rate | 3 months | Number of procedure related adverse events occurring within 3 months of the index procedure |
| Change in Systemic Systolic Arterial Blood Pressure | Baseline to Post Index Procedure | Change in systemic systolic arterial blood pressure at termination of the index procedure as compared to the pre-procedure assessment. |
Countries
Germany, Italy, Portugal, Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | AngioJet Ultra PE Thrombectomy System |
|---|---|
| Age, Continuous | 62.3 years STANDARD_DEVIATION 8 |
| Body Mass Index (BMI) | 28.33 kg/m2 STANDARD_DEVIATION 4.43 |
| Height | 170.0 cm STANDARD_DEVIATION 12.6 |
| Region of Enrollment Italy | 4 participants |
| Region of Enrollment Portugal | 2 participants |
| Region of Enrollment Switzerland | 1 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 5 Participants |
| Weight | 82.6 kg STANDARD_DEVIATION 19.5 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 7 |
| serious Total, serious adverse events | 4 / 7 |
Outcome results
Primary
Change in Right Ventricular (RV) to Left Ventricular (LV) Ratio at 24 - 48 Hours as Measured by Echocardiography
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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
Change in Heart Rate
Change in heart rate at termination of the index procedure as compared to the pre-procedure assessment.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AngioJet Ultra PE Thrombectomy System | Change in Heart Rate | -12.2 beats per minute | Standard Deviation 9.4 |
Secondary
Change in Systemic Systolic Arterial Blood Pressure
Change in systemic systolic arterial blood pressure at termination of the index procedure as compared to the pre-procedure assessment.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AngioJet Ultra PE Thrombectomy System | Change in Systemic Systolic Arterial Blood Pressure | 14.7 mmHg | Standard Deviation 22.1 |
Secondary
Change in Systolic Pulmonary Arterial Blood Pressure
Change in systolic pulmonary arterial blood pressure at termination of the index procedure as compared to the pre-procedure assessment.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AngioJet Ultra PE Thrombectomy System | Change in Systolic Pulmonary Arterial Blood Pressure | -8.3 mmHg | Standard Deviation 11.8 |
Secondary
Death - All Cause
Number of participant deaths due to any reason occurring within 3 months of the index procedure.
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AngioJet Ultra PE Thrombectomy System | Death - All Cause | 1 participants |
Secondary
Death - Cardiac Cause
Number of participant deaths due to cardiac causes occurring within 3 months of the index procedure.
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AngioJet Ultra PE Thrombectomy System | Death - Cardiac Cause | 0 participants |
Secondary
Procedure Related Adverse Event Rate
Number of procedure related adverse events occurring within 3 months of the index procedure
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AngioJet Ultra PE Thrombectomy System | Procedure Related Adverse Event Rate | 0 events |
Secondary
Pulmonary Systolic Arterial Blood Pressure
Pulmonary systolic arterial blood pressure at termination of the index procedure.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AngioJet Ultra PE Thrombectomy System | Pulmonary Systolic Arterial Blood Pressure | 44.2 mmHg | Standard Deviation 11.3 |
Secondary
Systemic Systolic Arterial Blood Pressure
Systemic systolic arterial blood pressure at termination of the index procedure.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AngioJet Ultra PE Thrombectomy System | Systemic Systolic Arterial Blood Pressure | 136.0 mmHg | Standard Deviation 18.5 |
Secondary
Technical Success
Percentage of patients with successful placement and operation of the AngioJet catheter in the pulmonary arteries during the index procedure
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AngioJet Ultra PE Thrombectomy System | Technical Success | 100 percentage of participants |
Secondary
Vasopressor Support
Percentage of participants receiving vasopressor support during the index procedure. Vasopressor support are medications administered to prevent the narrowing of blood vessels.
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AngioJet Ultra PE Thrombectomy System | Vasopressor Support | 0 percentage of participants |