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

Phase 4

Terminated

• Conditions: Pulmonary Embolism
• Interventions: Device: AngioJet Ultra PE Thrombectomy System

• Registration Number: NCT01638468
• Lead Sponsor: Boston Scientific Corporation

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-07-06
• Study First Submitted QC: 2012-07-09
• Study First Posted: 2012-07-11
• Study Start: 2013-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Results First Submitted: 2016-09-12
• Results First Submitted QC: 2016-09-12
• Results First Posted: 2016-11-01
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-12
• Last Update Posted: 2018-12-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AngioJet Ultra PE Thrombectomy System	AngioJet Ultra PE Thrombectomy System	Patients are treated with the AngioJet Ultra PE Thrombectomy System

Primary Outcome Measures

Name	Time	Method
Change in Right Ventricular (RV) to Left Ventricular (LV) Ratio at 24 - 48 Hours as Measured by Echocardiography	Baseline to 24-48 hours	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

Name	Time	Method
Technical Success	Index Procedure	Percentage of patients with successful placement and operation of the AngioJet catheter in the pulmonary arteries during the index procedure
Death - All Cause	3 months	Number of participant deaths due to any reason occurring within 3 months of the index procedure.
Pulmonary Systolic Arterial Blood Pressure	Post Index Procedure	Pulmonary systolic arterial blood pressure at termination of the index procedure.
Systemic Systolic Arterial Blood Pressure	Post Index Procedure	Systemic systolic arterial blood pressure at termination of the index procedure.
Change in Heart Rate	Baseline to Post Index Procedure	Change in heart rate at termination of the index procedure as compared to the pre-procedure assessment.
Procedure Related Adverse Event Rate	3 months	Number of procedure related adverse events occurring within 3 months of the index procedure
Death - Cardiac Cause	3 months	Number of participant deaths due to cardiac causes occurring within 3 months of the index procedure.
Vasopressor Support	Index Procedure	Percentage of participants receiving vasopressor support during the index procedure. Vasopressor support are medications administered to prevent the narrowing of blood vessels.
Change in Systolic Pulmonary Arterial Blood Pressure	Baseline to Post Index Procedure	Change in systolic pulmonary arterial blood pressure at termination of the index procedure as compared to the pre-procedure assessment.
Change in Systemic Systolic Arterial Blood Pressure	Baseline to Post Index Procedure	Change in systemic systolic arterial blood pressure at termination of the index procedure as compared to the pre-procedure assessment.

Trial Locations

Locations (7)

Universita Federico II di Napoli; 🇮🇹 Napoli, Italy

University Hospital Bern; 🇨🇭 Bern, Switzerland

Ospedale Sant' Anna Di Como; 🇮🇹 San Fermo della Battaglia, Italy

Ospedale S. Maria Delle Croci; 🇮🇹 Ravenna, Italy

EO Ospedali Galliera - Genova; 🇮🇹 Genova, Italy

Centro Hospitalar de Vila Nova de Gaia; 🇵🇹 Vila Nova de Gaia, Portugal

Universitätsklinikum Münster; 🇩🇪 Münster, Germany