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

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

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.

Study Overview

• Status: Terminated
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Device: AngioJet Ultra PE Thrombectomy System

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Münster, Germany
    • Universitatsklinikum Munster
• Italy
  • Genova, Italy, 16128
    • EO Ospedali Galliera - Genova
  • Napoli, Italy, 80131
    • Universita Federico II di Napoli
  • Ravenna, Italy
    • Ospedale S. Maria Delle Croci
  • San Fermo della Battaglia, Italy, 22020
    • Ospedale Sant' Anna Di Como
• Portugal
  • Vila Nova de Gaia, Portugal, 4434-502
    • Centro Hospitalar de Vila Nova de Gaia
• Switzerland
  • Bern, Switzerland, 3010
    • University Hospital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: AngioJet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Nils Kucher, Prof Dr Med, University of Bern

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: July 6, 2012
• First Submitted That Met QC Criteria: July 9, 2012
• First Posted (Estimate): July 11, 2012

Study Record Updates

• Last Update Posted (Actual): December 5, 2018
• Last Update Submitted That Met QC Criteria: November 12, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Acute Pulmonary Embolism; Pulmonary Embolism; Pulmonary Thromboembolism; Sub-massive Pulmonary Embolism; Massive Pulmonary Embolism
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID Numbers: PERFUSE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No