Multicenter, Nonrandomized, Prospective Study of Pulmonary Embolism Removal With the AngioJet 6F Ultra System (PERFUSE)
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|ClinicalTrials.gov Identifier: NCT01638468|
Recruitment Status : Terminated (Slow Enrollment)
First Posted : July 11, 2012
Results First Posted : November 1, 2016
Last Update Posted : November 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Embolism||Device: AngioJet Ultra PE Thrombectomy System||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pulmonary Embolism Removal With the AngioJet 6F Ultra SystEm (PERFUSE)|
|Study Start Date :||January 2013|
|Primary Completion Date :||January 2016|
|Study Completion Date :||January 2016|
Experimental: AngioJet Ultra PE Thrombectomy System
Patients are treated with the AngioJet Ultra PE Thrombectomy System
Device: AngioJet Ultra PE Thrombectomy System
Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System
Other Name: AngioJet
- Change in Right Ventricular (RV) to Left Ventricular (LV) Ratio at 24 - 48 Hours as Measured by Echocardiography [ Time Frame: 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.
- Technical Success [ Time Frame: Index Procedure ]Percentage of patients with successful placement and operation of the AngioJet catheter in the pulmonary arteries during the index procedure
- Death - All Cause [ Time Frame: 3 months ]Number of participant deaths due to any reason occurring within 3 months of the index procedure.
- Death - Cardiac Cause [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Post Index Procedure ]Pulmonary systolic arterial blood pressure at termination of the index procedure.
- Change in Systemic Systolic Arterial Blood Pressure [ Time Frame: 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.
- Systemic Systolic Arterial Blood Pressure [ Time Frame: Post Index Procedure ]Systemic systolic arterial blood pressure at termination of the index procedure.
- Change in Heart Rate [ Time Frame: Baseline to Post Index Procedure ]Change in heart rate at termination of the index procedure as compared to the pre-procedure assessment.
- Vasopressor Support [ Time Frame: 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 [ Time Frame: 3 months ]Number of procedure related adverse events occurring within 3 months of the index procedure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01638468
|EO Ospedali Galliera - Genova|
|Genova, Italy, 16128|
|Universita Federico II di Napoli|
|Napoli, Italy, 80131|
|Ospedale S. Maria Delle Croci|
|Ospedale Sant' Anna Di Como|
|San Fermo della Battaglia, Italy, 22020|
|Centro Hospitalar de Vila Nova de Gaia|
|Vila Nova de Gaia, Portugal, 4434-502|
|University Hospital Bern|
|Bern, Switzerland, 3010|
|Principal Investigator:||Nils Kucher, Prof Dr Med||University of Bern|