Multicenter, Nonrandomized, Prospective Study of Pulmonary Embolism Removal With the AngioJet 6F Ultra System (PERFUSE)
Primary Purpose
Pulmonary Embolism
Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
AngioJet Ultra PE Thrombectomy System
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Embolism focused on measuring Pulmonary Embolism, Acute Pulmonary Embolism, Sub-massive Pulmonary Embolism, Massive Pulmonary Embolism, Pulmonary Thromboembolism
Eligibility Criteria
Inclusion Criteria:
- Symptomatic pulmonary embolism patients >18 years
- 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
- 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
- Echocardiographic evidence of right ventricular dilatation with a subannular RV/LV ratio ≥ 0.9 from the apical or subcostal four-chamber view
- Appropriate informed consent was obtained from the patient or legal representative
Exclusion Criteria:
- Patient has underwent Cardiopulmonary Resuscitation (CPR) in the last 48 hours
- Patient is participating in any other clinical study
- 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)
- Inability to comply with study Follow-up assessments (e.g. due to geographic)
- Previous enrollment in this study
Sites / Locations
- Universitätsklinikum Münster
- EO Ospedali Galliera - Genova
- Universita Federico II di Napoli
- Ospedale S. Maria Delle Croci
- Ospedale Sant' Anna Di Como
- Centro Hospitalar de Vila Nova de Gaia
- University Hospital Bern
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AngioJet Ultra PE Thrombectomy System
Arm Description
Patients are treated with the AngioJet Ultra PE Thrombectomy System
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Technical Success
Percentage of patients with successful placement and operation of the AngioJet catheter in the pulmonary arteries during the index procedure
Death - All Cause
Number of participant deaths due to any reason occurring within 3 months of the index procedure.
Death - Cardiac Cause
Number of participant deaths due to cardiac causes occurring within 3 months of the index procedure.
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.
Pulmonary Systolic Arterial Blood Pressure
Pulmonary systolic arterial blood pressure at termination of the 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.
Systemic Systolic Arterial Blood Pressure
Systemic systolic arterial blood pressure at termination of the index procedure.
Change in Heart Rate
Change in heart rate at termination of the index procedure as compared to the pre-procedure assessment.
Vasopressor Support
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
Number of procedure related adverse events occurring within 3 months of the index procedure
Full Information
NCT ID
NCT01638468
First Posted
July 6, 2012
Last Updated
November 12, 2018
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01638468
Brief Title
Multicenter, Nonrandomized, Prospective Study of Pulmonary Embolism Removal With the AngioJet 6F Ultra System
Acronym
PERFUSE
Official Title
Pulmonary Embolism Removal With the AngioJet 6F Ultra SystEm (PERFUSE)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow Enrollment
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
Keywords
Pulmonary Embolism, Acute Pulmonary Embolism, Sub-massive Pulmonary Embolism, Massive Pulmonary Embolism, Pulmonary Thromboembolism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AngioJet Ultra PE Thrombectomy System
Arm Type
Experimental
Arm Description
Patients are treated with the AngioJet Ultra PE Thrombectomy System
Intervention Type
Device
Intervention Name(s)
AngioJet Ultra PE Thrombectomy System
Other Intervention Name(s)
AngioJet
Intervention Description
Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System
Primary Outcome Measure Information:
Title
Change in Right Ventricular (RV) to Left Ventricular (LV) Ratio at 24 - 48 Hours as Measured by Echocardiography
Description
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
Secondary Outcome Measure Information:
Title
Technical Success
Description
Percentage of patients with successful placement and operation of the AngioJet catheter in the pulmonary arteries during the index procedure
Time Frame
Index Procedure
Title
Death - All Cause
Description
Number of participant deaths due to any reason occurring within 3 months of the index procedure.
Time Frame
3 months
Title
Death - Cardiac Cause
Description
Number of participant deaths due to cardiac causes occurring within 3 months of the index procedure.
Time Frame
3 months
Title
Change in Systolic Pulmonary Arterial Blood Pressure
Description
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
Title
Pulmonary Systolic Arterial Blood Pressure
Description
Pulmonary systolic arterial blood pressure at termination of the index procedure.
Time Frame
Post Index Procedure
Title
Change in Systemic Systolic Arterial Blood Pressure
Description
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
Title
Systemic Systolic Arterial Blood Pressure
Description
Systemic systolic arterial blood pressure at termination of the index procedure.
Time Frame
Post Index Procedure
Title
Change in Heart Rate
Description
Change in heart rate at termination of the index procedure as compared to the pre-procedure assessment.
Time Frame
Baseline to Post Index Procedure
Title
Vasopressor Support
Description
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
Title
Procedure Related Adverse Event Rate
Description
Number of procedure related adverse events occurring within 3 months of the index procedure
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Symptomatic pulmonary embolism patients >18 years
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
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
Echocardiographic evidence of right ventricular dilatation with a subannular RV/LV ratio ≥ 0.9 from the apical or subcostal four-chamber view
Appropriate informed consent was obtained from the patient or legal representative
Exclusion Criteria:
Patient has underwent Cardiopulmonary Resuscitation (CPR) in the last 48 hours
Patient is participating in any other clinical study
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)
Inability to comply with study Follow-up assessments (e.g. due to geographic)
Previous enrollment in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nils Kucher, Prof Dr Med
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Münster
City
Münster
Country
Germany
Facility Name
EO Ospedali Galliera - Genova
City
Genova
ZIP/Postal Code
16128
Country
Italy
Facility Name
Universita Federico II di Napoli
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale S. Maria Delle Croci
City
Ravenna
Country
Italy
Facility Name
Ospedale Sant' Anna Di Como
City
San Fermo della Battaglia
ZIP/Postal Code
22020
Country
Italy
Facility Name
Centro Hospitalar de Vila Nova de Gaia
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
University Hospital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multicenter, Nonrandomized, Prospective Study of Pulmonary Embolism Removal With the AngioJet 6F Ultra System
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