Clinical trial NCT01638468: Multicenter, Nonrandomized, Prospective Study of Pulmonary Embolism Removal With the AngioJet 6F Ultra System
Official title: Pulmonary Embolism Removal With the AngioJet 6F Ultra SystEm (PERFUSE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pulmonary Embolism
Keywords: Pulmonary Embolism
Acute Pulmonary Embolism
Sub-massive Pulmonary Embolism
Massive Pulmonary Embolism
Pulmonary Thromboembolism
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2012-07-11
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Right Ventricular (RV) to Left Ventricular (LV) Ratio at 24 - 48 Hours as Measured by Echocardiography
timeFrame: Baseline to 24-48 hours
Secondary outcomes:
measure: Technical Success
timeFrame: Index Procedure
measure: Death - All Cause
timeFrame: 3 months
measure: Death - Cardiac Cause
timeFrame: 3 months
measure: Change in Systolic Pulmonary Arterial Blood Pressure
timeFrame: Baseline to Post Index Procedure
measure: Pulmonary Systolic Arterial Blood Pressure
timeFrame: Post Index Procedure
measure: Change in Systemic Systolic Arterial Blood Pressure
timeFrame: Baseline to Post Index Procedure
measure: Systemic Systolic Arterial Blood Pressure
timeFrame: Post Index Procedure
measure: Change in Heart Rate
timeFrame: Baseline to Post Index Procedure
measure: Vasopressor Support
timeFrame: Index Procedure
measure: Procedure Related Adverse Event Rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Genova
country: Italy
facility: EO Ospedali Galliera - Genova
city: Napoli
country: Italy
facility: Universita Federico II di Napoli
city: Ravenna
country: Italy
facility: Ospedale S. Maria Delle Croci
city: San Fermo della Battaglia
country: Italy
facility: Ospedale Sant' Anna Di Como
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia
city: Bern
country: Switzerland
facility: University Hospital Bern
Study officials:
affiliation: University of Bern
name: Nils Kucher, Prof Dr Med
role: PRINCIPAL_INVESTIGATOR
References: