Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-27 @ 8:56 PM
Study NCT ID:
NCT01638468
Status:
TERMINATED
Last Update Posted:
2018-12-05
First Post:
2012-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multicenter, Nonrandomized, Prospective Study of Pulmonary Embolism Removal With the AngioJet 6F Ultra System
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
Pulmonary Embolism Removal With the AngioJet 6F Ultra SystEm (PERFUSE)
Status:
TERMINATED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow Enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERFUSE
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: