Multicenter, Nonrandomized, Prospective Study of Pulmonary Embolism Removal With the AngioJet 6F Ultra System

Pulmonary Embolism Clinical Trial

— PERFUSE  

Official title:

Pulmonary Embolism Removal With the AngioJet 6F Ultra SystEm (PERFUSE)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01638468
• Other study ID #: PERFUSE
• Status: Terminated
• Phase: Phase 4
• Start date: January 2013
• Est. completion date: January 2016

Study information

• Verified date: November 2018
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Device:
• AngioJet Ultra PE Thrombectomy System
Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System

Locations

Country	Name	City	State
Germany	Universitätsklinikum Münster	Münster
Italy	EO Ospedali Galliera - Genova	Genova
Italy	Universita Federico II di Napoli	Napoli
Italy	Ospedale S. Maria Delle Croci	Ravenna
Italy	Ospedale Sant' Anna Di Como	San Fermo della Battaglia
Portugal	Centro Hospitalar de Vila Nova de Gaia	Vila Nova de Gaia
Switzerland	University Hospital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Germany,  Italy,  Portugal,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline to 24-48 hours
Secondary	Technical Success	Percentage of patients with successful placement and operation of the AngioJet catheter in the pulmonary arteries during the index procedure	Index Procedure
Secondary	Death - All Cause	Number of participant deaths due to any reason occurring within 3 months of the index procedure.	3 months
Secondary	Death - Cardiac Cause	Number of participant deaths due to cardiac causes occurring within 3 months of the index procedure.	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.	Baseline to Post Index Procedure
Secondary	Pulmonary Systolic Arterial Blood Pressure	Pulmonary systolic arterial blood pressure at termination of the index procedure.	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.	Baseline to Post Index Procedure
Secondary	Systemic Systolic Arterial Blood Pressure	Systemic systolic arterial blood pressure at termination of the index procedure.	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.	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.	Index Procedure
Secondary	Procedure Related Adverse Event Rate	Number of procedure related adverse events occurring within 3 months of the index procedure	3 months