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

• ClinicalTrials.gov Identifier: NCT01097928
• Recruitment Status: Unknown
• First Posted: April 2, 2010
• Last Update Posted: July 12, 2019
• Sponsor: Stanford University
• Collaborators: Adventist Midwest Health; Weill Medical College of Cornell University; Memorial Hospital of South Bend; Northside Hospital, Inc.; Universidad de Zaragoza
• Information provided by (Responsible Party): William Kuo, Stanford University

Tracking Information

• First Submitted Date: March 30, 2010
• First Posted Date: April 2, 2010
• Last Update Posted Date: July 12, 2019
• Study Start Date: January 2010
• Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 31, 2010)

• Resolution of hypoxia [ Time Frame: Post-procedure and 3 months ]
• Survival from acute PE [ Time Frame: Post-procedure and 3 months ]
• Stabilization of hemodynamics [ Time Frame: Post-procedure and 3 months ]

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: March 31, 2010): Clinical practice patterns across centers [ Time Frame: 5yrs ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pulmonary Embolism Response to Fragmentation, Embolectomy, & Catheter Thrombolysis: PERFECT
• Official Title: Pulmonary Embolism Response to Fragmentation, Embolectomy, & Catheter Thrombolysis: The PERFECT Registry
• Brief Summary: 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)

Detailed 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

• Study Type: Observational
• Study Design: Observational Model: Other; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Any adult patient who has developed a pulmonary embolism, and who will be undergoing catheter directed debulking of the embolus.
• Condition: Pulmonary Embolism

Intervention

Procedure: Catheter directed debulking of Pulmonary Embolus

A catheter will be used to break up the pulmonary embolism

Study Groups/Cohorts

Patients undergoing Pulmonary Embolectomy

Intervention: Procedure: Catheter directed debulking of Pulmonary Embolus

• Publications *: Kuo WT, Banerjee A, Kim PS, DeMarco FJ Jr, Levy JR, Facchini FR, Unver K, Bertini MJ, Sista AK, Hall MJ, Rosenberg JK, De Gregorio MA. Pulmonary Embolism Response to Fragmentation, Embolectomy, and Catheter Thrombolysis (PERFECT): Initial Results From a Prospective Multicenter Registry. Chest. 2015 Sep;148(3):667-673. doi: 10.1378/chest.15-0119.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 31, 2010): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2020
• Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01097928
• Other Study ID Numbers: SU-03292010-5502; eProtocol ID 14793
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: William Kuo, Stanford University
• Original Responsible Party: William T Kuo MD, Stanford University School of Medicine
• Current Study Sponsor: Stanford University
• Original Study Sponsor: Same as current

Collaborators

• Adventist Midwest Health
• Weill Medical College of Cornell University
• Memorial Hospital of South Bend
• Northside Hospital, Inc.
• Universidad de Zaragoza

Investigators

• Principal Investigator: William T Kuo MD; Stanford University

• PRS Account: Stanford University
• Verification Date: July 2019