Not provided
Not provided
Not provided
Not provided
Slow Enrollment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AngioJet Ultra PE Thrombectomy System | Experimental | Patients are treated with the AngioJet Ultra PE Thrombectomy System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AngioJet Ultra PE Thrombectomy System | Device | Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 24-48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success | Percentage of patients with successful placement and operation of the AngioJet catheter in the pulmonary arteries during the index procedure | Index Procedure |
| Death - All Cause |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nils Kucher, Prof Dr Med | University of Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Münster | Münster | Germany | ||||
| EO Ospedali Galliera - Genova |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint | Posted | Mean | Standard Deviation | ratio | Baseline to 24-48 hours |
|
Adverse events were collected from the index procedure through the 3 month follow up visit.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Embolism, Re-occurring | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Schutt | Boston Scientific | 763-494-2166 | angela.schutt@bsci.com |
| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Number of participant deaths due to any reason occurring within 3 months of the index procedure.
| 3 months |
| Death - Cardiac Cause | Number of participant deaths due to cardiac causes occurring within 3 months of the index procedure. | 3 months |
| 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. | Baseline to Post Index Procedure |
| Pulmonary Systolic Arterial Blood Pressure | Pulmonary systolic arterial blood pressure at termination of the index procedure. | Post Index Procedure |
| 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. | Baseline to Post Index Procedure |
| Systemic Systolic Arterial Blood Pressure | Systemic systolic arterial blood pressure at termination of the index procedure. | Post Index Procedure |
| Change in Heart Rate | Change in heart rate at termination of the index procedure as compared to the pre-procedure assessment. | Baseline to Post Index Procedure |
| Vasopressor Support | Percentage of participants receiving vasopressor support during the index procedure. Vasopressor support are medications administered to prevent the narrowing of blood vessels. | Index Procedure |
| Procedure Related Adverse Event Rate | Number of procedure related adverse events occurring within 3 months of the index procedure | 3 months |
| Genova |
| 16128 |
| Italy |
| Universita Federico II di Napoli | Naples | 80131 | Italy |
| Ospedale S. Maria Delle Croci | Ravenna | Italy |
| Ospedale Sant' Anna Di Como | San Fermo della Battaglia | 22020 | Italy |
| Centro Hospitalar de Vila Nova de Gaia | Vila Nova de Gaia | 4434-502 | Portugal |
| University Hospital Bern | Bern | 3010 | Switzerland |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
|
|
| Secondary | Technical Success | Percentage of patients with successful placement and operation of the AngioJet catheter in the pulmonary arteries during the index procedure | Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint | Posted | Number | percentage of participants | Index Procedure |
|
|
|
| Secondary | Death - All Cause | Number of participant deaths due to any reason occurring within 3 months of the index procedure. | Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint | Posted | Number | participants | 3 months |
|
|
|
| Secondary | Death - Cardiac Cause | Number of participant deaths due to cardiac causes occurring within 3 months of the index procedure. | Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint | Posted | Number | participants | 3 months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline to Post Index Procedure |
|
|
|
| Secondary | Pulmonary Systolic Arterial Blood Pressure | Pulmonary systolic arterial blood pressure at termination of the index procedure. | 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. | Posted | Mean | Standard Deviation | mmHg | Post Index Procedure |
|
|
|
| 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. | Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint | Posted | Mean | Standard Deviation | mmHg | Baseline to Post Index Procedure |
|
|
|
| Secondary | Systemic Systolic Arterial Blood Pressure | Systemic systolic arterial blood pressure at termination of the index procedure. | Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint. | Posted | Mean | Standard Deviation | mmHg | Post Index Procedure |
|
|
|
| Secondary | Change in Heart Rate | Change in heart rate at termination of the index procedure as compared to the pre-procedure assessment. | 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. | Posted | Mean | Standard Deviation | beats per minute | Baseline to Post Index Procedure |
|
|
|
| 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. | Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint | Posted | Number | percentage of participants | Index Procedure |
|
|
|
| Secondary | Procedure Related Adverse Event Rate | Number of procedure related adverse events occurring within 3 months of the index procedure | Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint | Posted | Number | events | 3 months |
|
|
|
| 4 |
| 7 |
| 1 |
| 7 |
| Death | Vascular disorders | Systematic Assessment |
|
| Bowel Obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Macrohematuria (presence of blood cells in urine) | Renal and urinary disorders | Systematic Assessment |
|
| Epistaxis (bleeding from the nose) | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |