Pulmonary EmbolismNCT01097928
Pulmonary Embolism Response to Fragmentation, Embolectomy, & Catheter Thrombolysis: PERFECT
An observational study of Pulmonary Embolism, run by Stanford University at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Catheter directed debulking of Pulmonary Embolus
- Type of treatment
- Surgery or procedure
- How many people
- 333 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to 31 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any adult patient who has developed a pulmonary embolism, and who will be undergoing catheter directed debulking of the embolus.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Pulmonary Embolism Response to Fragmentation, Embolectomy, & Catheter Thrombolysis: The PERFECT Registry
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)
Read the 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
- Conditions
- Pulmonary Embolism
- Being tested
- Catheter directed debulking of Pulmonary Embolus
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter directed debulking of Pulmonary EmbolusProcedure or surgery
A catheter will be used to break up the pulmonary embolism
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing Pulmonary Embolectomy | Not described Receives: Procedure: Catheter directed debulking of Pulmonary Embolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of hypoxia
Measured: Post-procedure and 3 months
Survival from acute PE
Measured: Post-procedure and 3 months
Stabilization of hemodynamics
Measured: Post-procedure and 3 months
Secondary outcomes (1)
Clinical practice patterns across centers
Measured: 5yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startJan 2010
- Primary completion13 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Adventist Midwest Health, Weill Medical College of Cornell University, Memorial Hospital of South Bend, Northside Hospital, Inc., Universidad de Zaragoza
- Responsible party
- Principal investigator, William Kuo, Stanford University
- Investigators
- William T Kuo MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097928
- Sponsor's protocol ID
- SU-03292010-5502
- Other IDs
- eProtocol ID 14793
- Status last verified
- Sep 2023
- First submitted
- 30 Mar 2010
- Last updated
- 8 Sep 2023
- Results posted
- No
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.
PubMed 25856269
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Embolism Response to Fragmentation, Embolectomy, & Catheter Thrombolysis: The PERFECT Registry
- ClinicalTrials.gov ID
- NCT01097928
- Acronym / sponsor ID
- SU-03292010-5502
- Conditions
- Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Adventist Midwest Health, Weill Medical College of Cornell University, Memorial Hospital of South Bend, Northside Hospital, Inc., Universidad de Zaragoza
- Study start
- Jan 2010 (actual)
- Primary completion
- 13 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 2 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing Pulmonary Embolectomy | – | Procedure: Catheter directed debulking of Pulmonary Embolus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any adult patient who has developed a pulmonary embolism, and who will be undergoing catheter directed debulking of the embolus.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter directed debulking of Pulmonary EmbolusA catheter will be used to break up the pulmonary embolism | Procedure or surgery | Patients undergoing Pulmonary Embolectomy |
Primary outcome
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
1 secondary outcome
Clinical practice patterns across centers
Time frame: 5yrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Derived from this study: PubMed 25856269Kuo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William T Kuo MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of hypoxia (time frame: Post-procedure and 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01097928, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.