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

Phase 4TerminatedNCT01638468

Boston Scientific Corporation7 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Embolism

Interventions

AngioJet Ultra PE Thrombectomy SystemDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Universitätsklinikum Münster

Münster, Germany

EO Ospedali Galliera - Genova

Genova, Italy

Universita Federico II di Napoli

Napoli, Italy

Ospedale S. Maria Delle Croci

Ravenna, Italy

Outcomes

Primary Outcomes

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.

Time frame: Baseline to 24-48 hours

Secondary Outcomes

Technical Success

Percentage of patients with successful placement and operation of the AngioJet catheter in the pulmonary arteries during the index procedure

Time frame: Index Procedure

Death - All Cause

Number of participant deaths due to any reason occurring within 3 months of the index procedure.

Time frame: 3 months

Death - Cardiac Cause

Number of participant deaths due to cardiac causes occurring within 3 months of the index procedure.

Time frame: 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.

Time frame: Baseline to Post Index Procedure

Pulmonary Systolic Arterial Blood Pressure

Pulmonary systolic arterial blood pressure at termination of the index procedure.

Time frame: Post Index Procedure

Change in Systemic Systolic Arterial Blood Pressure

Data from ClinicalTrials.gov

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