Pulmonary Embolism Response to Fragmentation, Embolectomy, & Catheter Thrombolysis: PERFECT

Stanford University

Status: Completed

Conditions: Pulmonary Embolism

Treatments: Procedure: Catheter directed debulking of Pulmonary Embolus

Study type: Observational

Funder types: Other

Identifiers

NCT01097928

SU-03292010-5502

eProtocol ID 14793

Details and patient eligibility

About

A prospective observational study to evaluate the safety and effectiveness data of catheter-directed therapy (CDT) including percutaneous mechanical thrombectomy (PMT) for treatment of acute pulmonary embolism (PE)

Full description

The primary objective of this study is to capture high quality patient safety and effectiveness data on CDT for acute PE. The goal will be achieved by capturing a concise set of immediate and short-term functional and clinical outcome data for PE patients undergoing CDT.

Secondary study objectives include the following:

• To assess and benchmark clinical practice patterns (patient selection, optimal technique, use of procedure worldwide)

These objectives will be achieved through the capture of selected process data for patients included in the registry. Data collected in this study may also be used to develop and refine standards of care for use of CDT for PE and to facilitate the design of randomized clinical trials

Enrollment: 333 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Must be Age greater than or equal to 18
• Obtain informed written consent.
• Diagnosed with acute pulmonary embolism (PE) (< 14 days)
• Catheter-directed therapy (CDT) was performed to treat acute PE

Trial design

333 participants in 1 patient group

Patients undergoing Pulmonary Embolectomy

Treatment:

Procedure: Catheter directed debulking of Pulmonary Embolus