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

This study is currently recruiting participants.
Verified March 2013 by MEDRAD, Inc.
Sponsor:
Information provided by (Responsible Party):
MEDRAD, Inc.
ClinicalTrials.gov Identifier:
NCT01638468
First received: July 6, 2012
Last updated: March 6, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Pulmonary Embolism
 Device: AngioJet Ultra PE Thrombectomy System
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pulmonary Embolism Removal With the AngioJet 6F Ultra SystEm (PERFUSE)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by MEDRAD, Inc.:

Primary Outcome Measures:
  • RV to LV Ratio [ Time Frame: 24-48 hours after baseline ] [ Designated as safety issue: Yes ]
    Determine the change in the subannular end-diastolic RV/LV ratio from pre-thrombectomy vs 24-48 hrs post thrombectomy as measured by echocardiography.


Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: AngioJet

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01638468

Locations
Switzerland
University Hospital Bern Recruiting
Bern, Switzerland, 3010
Contact: Nils Kucher, Prof Dr med         nils.kucher@insel.ch    
Sponsors and Collaborators
MEDRAD, Inc.
Investigators
Principal Investigator: Nils Kucher, Prof Dr Med University of Bern
  More Information

No publications provided

Responsible Party: MEDRAD, Inc.
ClinicalTrials.gov Identifier: NCT01638468     History of Changes
Other Study ID Numbers: PERFUSE
Study First Received: July 6, 2012
Last Updated: March 6, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by MEDRAD, Inc.:
Pulmonary Embolism
Acute Pulmonary Embolism
Sub-massive Pulmonary Embolism
Massive Pulmonary Embolism
Pulmonary Thromboembolism

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 13, 2013