Pulmonary EmbolismPRESERVENCT02381509
Predicting the Safety and Effectiveness of Inferior Vena Cava Filters
An observational study of Pulmonary Embolism and Deep Vein Thrombosis, run by Carelon Research at 53 sites in United States.
Trial summary
PRESERVE is a multi-center, prospective, open-label, non-randomized investigation of commercially available IVC filters from 6 manufacturers placed in subjects for the prevention of pulmonary embolism (PE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Deep Vein Thrombosis
- What is being tested?
- IVC Filter
- Type of treatment
- Medical device
- How many people
- 1,428 participants
- Where
- 53 sitesUnited States
- Study dates
- Oct 2015to 20 Sep 2021
- 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: Subjects requiring the placement of one of 6 IVC filters for the prevention of PE.
Who may be able to join
- Male or Female, age 18 years or older;
- Requires IVC filter for prevention of pulmonary embolism (PE);
- Provide written informed consent and written HIPAA authorization prior to initiation of study procedures;
- Willing to comply with the specified follow-up
Who cannot join
- Subject is unable to participate in study evaluations pre- and post-treatment
- Known sensitivity to contrast or serious contrast reaction such as anaphylaxis for which premedication is known to be unsuccessful in alleviating symptoms
Trial locations and contacts
53 sites in 1 country.
53 sites in 1 country
United States53 sites
Albany Medical Center
Albany, New York, 12208
University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado
Aurora, Colorado, 80045
Boston Medical Center
Boston, Massachusetts, 02118
Massachusetts General Hospital
Boston, Massachusetts, 02446
Carolinas Medical Center
Charlotte, North Carolina, 28203
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
UT Southwestern
Dallas, Texas, 75390
Miami Valley Hospital/Wright State University
Dayton, Ohio, 45409
Duke Medical Center
Durham, North Carolina, 27710
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Holy Cross Hospital
Fort Lauderdale, Florida, 33301
Hackensack UMC
Hackensack, New Jersey, 07601
Memorial Hermann Hospital
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
Fairfield Medical Center
Lancaster, Ohio, 43130
The Heart Institute Largo
Largo, Florida, 33770
University of Arkansas
Little Rock, Arkansas, 72205
Ronald Regan UCLA Medical Center
Los Angeles, California, 90024
Feinstein Institute
Manhasset, New York, 11030
University of Miami Hospital and Clinics/Jackson Memorial
Miami, Florida, 33136
Medical College of WI/Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
Yale New Haven Hospital
New Haven, Connecticut, 06501
Mount Sinai Hospital
New York, New York, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
NY Presbyterian Weil Cornell Medical Ctr
New York, New York, 10065
Southcoast Hospital
North Dartmouth, Massachusetts, 02747
Florida Hospital
Orlando, Florida, 32803
Palo Alto VA
Palo Alto, California, 94304
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Oregon Health & Science Center
Portland, Oregon, 97239
Rhode Island Hospital/Miriam Hospital
Providence, Rhode Island, 02903
Mayo Clinic
Rochester, Minnesota, 55905
Rochester Regional Health System
Rochester, New York, 14621
William Beaumont Hospital
Royal Oak, Michigan, 48073
University of California San Francisco
San Francisco, California, 94118
Sarasota Memorial Hospital
Sarasota, Florida, 34239
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, 71130
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303
St. Louis University
St Louis, Missouri, 63110
Washington University
St Louis, Missouri, 63110
Overlook Medical Center
Summit, New Jersey, 07901
University Hospital/SUNY Upstate
Syracuse, New York, 13210
Tallahasse Memorial Hospital
Tallahassee, Florida, 32308
Harbor-UCLA Medical Center
Torrance, California, 90502
University of Oklahoma-Tulsa
Tulsa, Oklahoma, 74104
Carle Heart & Vascular Institute
Urbana, Illinois, 61801
Medstar Georgetown
Washington D.C., District of Columbia, 20007
St. Mary's Medical Center
West Palm Beach, Florida, 33407
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
PRESERVE is a multi-center, prospective, open-label, non-randomized investigation of commercially available IVC filters from 6 manufacturers placed in subjects for the prevention of pulmonary embolism (PE). This study will enroll up to 1,800 IVC filter subjects (with a maximum of 300 subjects per IVC filter brand) at up to 60 sites in the US. The primary objective of this investigational device exemption (IDE) clinical investigation is to evaluate the safety and effectiveness of the commercially available IVC filters (retrievable and permanent) in subjects with clinical need for mechanical prophylaxis of PE with an IVC filter.
Read the detailed description
The overall goal is to characterize the current practice of IVC filter placement, including the indications, filter type, frequency and success of filter removal, safety of placement initially and in the long term, including filter mechanical stability and caval patency, and the frequency of subsequent episodes of PE and recurrence of DVT. The first steps are to identify the characteristics of use in a broad range of clinical practice settings in the US.
Commercially available IVC filters from 6 manufacturers in the United States will be used. The type of FDA-cleared IVC filter implanted will be left to the discretion of the Principal Investigator at the Site. The following IVC filters will be utilized in this trial:
- ALN Vena Cava Filter (with and without hook) (ALN Implants Chirurgicaux)
- Option™ Elite Retrievable Vena Cava Filter (Argon Medical Devices Inc., designed and manufactured by Rex Medical)
- VenaTech® LP Vena Cava Filter (B Braun Interventional Systems, Inc.) and VenaTech® Convertible™ Vena Cava Filter
- DENALI® Vena Cava Filter System (DL900F, DL900J) (Bard Peripheral Vascular, Inc.)
- Cook Günther-Tulip™ Vena Cava Filter (Cook Incorporated)
- Cordis OPTEASE® Retrievable Vena Cava Filter and Cordis TRAPEASE® Permanent Vena Cava Filter (Cordis Corporation)
Subjects will be evaluated at Procedure, Discharge, 3-months, 6-months (phone), 12-months, 18-months (phone), and 24-months post-procedure. All subjects in whom the IVC filter is removed will be followed for 1-month postretrieval. Mandated follow-up imaging will be performed at 3 months (plain film) and 12 and 24 months (contrast abdominal CT). In addition, clinical visits with physical exam will be performed at 3 months, 12 months and 24 months.
- Conditions
- Pulmonary Embolism, Deep Vein Thrombosis
- Being tested
- IVC Filter
- Keywords
- inferior vena cava filters
- Medical subject headings
- Pulmonary Embolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVC FilterDevice
| Study group | Role | What they receive |
|---|---|---|
| IVC Filter | IVC filter for the prevention of PE Receives: Device: IVC Filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite safety endpoint of freedom from clinically significant perforation after successful filter placement, filter embolization, caval thrombotic occlusion, deep vein thrombosis, and perioperative serious adverse event
Clinically significant perforation is defined as protrusion of filter legs through the wall of the IVC causing hemorrhage or hematoma or touching, impressing, or perforating another organ or that triggers the decision to remove the filter; resulting in an attempt to remove the IVC filter or requiring other intervention. Filter embolization is defined as movement of the filter or its components to a distant anatomic site completely out of the target zone after successful filter placement, confirmed by imaging. Caval thrombotic occlusion is defined as presence of an occluding thrombus in the IVC after filter insertion and documented by ultrasound (US), computed tomography (CT), magnetic resonance (MR) imaging, venography, or autopsy; this may be symptomatic or asymptomatic after successful filter placement. Deep vein thrombosis (DVT) is defined as new symptomatic DVT post-deployment, as determined by standard of care imaging. Serious adverse event is defined by ISO 14155.
Measured: Within first 365 days (± 30 days)
Composite effectiveness endpoint of procedural and technical success without occurrence of clinically significant pulmonary embolism
New symptomatic PE confirmed by appropriate imaging
Measured: At 12-months in-situ or 1-month post-retrieval (whichever comes first)
Secondary outcomes (6)
Mechanical Stability
Defined by absence of: 1) Migration: cephalad movement of the filter >20mm relative to fixed anatomic landmarks compared to the time of placement, 2) Migration: caudal migration of the filter >20mm relative to fixed anatomic landmarks compared to the time of placement, 3) Perforation: >5mm outside apparent cava wall as determined by CT or perforation of adjacent viscera or major vessel, 4) Filter fracture: any loss of a filter's structural integrity (i.e. breakage or separation) documented by imaging or autopsy, 5) Filter embolization: post-deployment movement of the filter or its components to a distant anatomic site completely out of the target zone
Measured: At 3-months, 6-months, 12-months, 18-months, 24-months or at the time of filter retrieval
Procedure-related complications
In the judgment of the Principal Investigator
Measured: At 3-months
Major adverse events (composite and individual components)
Defined as death, PE, caval thrombotic occlusion, DVT, clinically significant perforation, retroperitoneal hematoma, or adjacent organ penetration
Measured: At 3-months, 6-months, 12-months, 18-months, and 24-months
Filter tilting >15°
As determined by appropriate imaging
Measured: At 3-months, 6-months, 12-months, 18-months, 24-months or at the time of filter retrieval
Filter retrieval
Includes: Attempted retrieval, Successful retrieval, Failed retrieval, Percentage of retrieval success, Complications associated with filter retrieval, Reasons for failed retrieval
Measured: Up to 24-months
Secondary Effectiveness Endpoint for each IVC filter brand tested only if the study is a success (i.e., both primary safety and effectiveness endpoints have been met)
PE rate
Measured: At 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startOct 2015
- Primary completion17 Mar 2020
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,428 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carelon Research
- Sponsor type
- University, hospital or other
- Collaborators
- ALN Implants Chirurgicaux, B. Braun Interventional Systems, Inc, Bard Peripheral Vascular, Inc., Cook Group Incorporated, Cordis US Corp., Argon Medical Devices, Society of Interventional Radiology Foundation, Society for Vascular Surgery
- Responsible party
- Sponsor
- Investigators
- David L. Gillespie, MD, FACS, Study chair, Cape Cod HospitalMatt Johnson, MD, Study chair, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381509
- Sponsor's protocol ID
- M01482
- Acronym
- PRESERVE
- Status last verified
- Sep 2021
- First submitted
- 2 Mar 2015
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
Publications
Johnson MS, Spies JB, Scott KT, Kato BS, Mu X, Rectenwald JE, White RA, Lewandowski RJ, Khaja MS, Zuckerman DA, Casciani T, Gillespie DL. Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE): Outcomes at 12 months. J Vasc Surg Venous Lymphat Disord. 2023 May;11(3):573-585.e6. doi: 10.1016/j.jvsv.2022.11.002. Epub 2023 Feb 23.
PubMed 36872169Johnson MS, Spies JB, Scott KT, Kato BS, Mu X, Rectenwald JE, White RA, Lewandowski RJ, Khaja MS, Zuckerman DA, Casciani T, Gillespie DL. Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE): Outcomes at 12 months. J Vasc Interv Radiol. 2023 Apr;34(4):517-528.e6. doi: 10.1016/j.jvir.2022.12.009. Epub 2023 Feb 23.
PubMed 36841633
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting the Safety and Effectiveness of Inferior Vena Cava Filters
- ClinicalTrials.gov ID
- NCT02381509
- Acronym / sponsor ID
- PRESERVE / M01482
- Conditions
- Pulmonary Embolism, Deep Vein Thrombosis
- Keywords
- inferior vena cava filters
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,428 participants (actual)
- Lead sponsor
- Carelon ResearchUniversity, hospital or other
- Collaborators
- ALN Implants Chirurgicaux, B. Braun Interventional Systems, Inc, Bard Peripheral Vascular, Inc., Cook Group Incorporated, Cordis US Corp., Argon Medical Devices, Society of Interventional Radiology Foundation, Society for Vascular Surgery
- Study start
- Oct 2015 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 6 Mar 2015 (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.
PRESERVE is a multi-center, prospective, open-label, non-randomized investigation of commercially available IVC filters from 6 manufacturers placed in subjects for the prevention of pulmonary embolism (PE). This study will enroll up to 1,800 IVC filter subjects (with a maximum of 300 subjects per IVC filter brand) at up to 60 sites in the US. The primary objective of this investigational device exemption (IDE) clinical investigation is to evaluate the safety and effectiveness of the commercially available IVC filters (retrievable and permanent) in subjects with clinical need for mechanical prophylaxis of PE with an IVC filter.
Detailed description
The overall goal is to characterize the current practice of IVC filter placement, including the indications, filter type, frequency and success of filter removal, safety of placement initially and in the long term, including filter mechanical stability and caval patency, and the frequency of subsequent episodes of PE and recurrence of DVT. The first steps are to identify the characteristics of use in a broad range of clinical practice settings in the US.
Commercially available IVC filters from 6 manufacturers in the United States will be used. The type of FDA-cleared IVC filter implanted will be left to the discretion of the Principal Investigator at the Site. The following IVC filters will be utilized in this trial:
- ALN Vena Cava Filter (with and without hook) (ALN Implants Chirurgicaux)
- Option™ Elite Retrievable Vena Cava Filter (Argon Medical Devices Inc., designed and manufactured by Rex Medical)
- VenaTech® LP Vena Cava Filter (B Braun Interventional Systems, Inc.) and VenaTech® Convertible™ Vena Cava Filter
- DENALI® Vena Cava Filter System (DL900F, DL900J) (Bard Peripheral Vascular, Inc.)
- Cook Günther-Tulip™ Vena Cava Filter (Cook Incorporated)
- Cordis OPTEASE® Retrievable Vena Cava Filter and Cordis TRAPEASE® Permanent Vena Cava Filter (Cordis Corporation)
Subjects will be evaluated at Procedure, Discharge, 3-months, 6-months (phone), 12-months, 18-months (phone), and 24-months post-procedure. All subjects in whom the IVC filter is removed will be followed for 1-month postretrieval. Mandated follow-up imaging will be performed at 3 months (plain film) and 12 and 24 months (contrast abdominal CT). In addition, clinical visits with physical exam will be performed at 3 months, 12 months and 24 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVC Filter | – | Device: IVC FilterIVC filter for the prevention of PE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects requiring the placement of one of 6 IVC filters for the prevention of PE.
Key inclusion criteria (4 listed)
- Male or Female, age 18 years or older;
- Requires IVC filter for prevention of pulmonary embolism (PE);
- Provide written informed consent and written HIPAA authorization prior to initiation of study procedures;
- Willing to comply with the specified follow-up
Key exclusion criteria (2 listed)
- Subject is unable to participate in study evaluations pre- and post-treatment
- Known sensitivity to contrast or serious contrast reaction such as anaphylaxis for which premedication is known to be unsuccessful in alleviating symptoms
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 |
|---|---|---|
| IVC Filter | Device | IVC Filter |
Primary outcome
Composite safety endpoint of freedom from clinically significant perforation after successful filter placement, filter embolization, caval thrombotic occlusion, deep vein thrombosis, and perioperative serious adverse event
Time frame: Within first 365 days (± 30 days)
Clinically significant perforation is defined as protrusion of filter legs through the wall of the IVC causing hemorrhage or hematoma or touching, impressing, or perforating another organ or that triggers the decision to remove the filter; resulting in an attempt to remove the IVC filter or requiring other intervention. Filter embolization is defined as movement of the filter or its components to a distant anatomic site completely out of the target zone after successful filter placement, confirmed by imaging. Caval thrombotic occlusion is defined as presence of an occluding thrombus in the IVC after filter insertion and documented by ultrasound (US), computed tomography (CT), magnetic resonance (MR) imaging, venography, or autopsy; this may be symptomatic or asymptomatic after successful filter placement. Deep vein thrombosis (DVT) is defined as new symptomatic DVT post-deployment, as determined by standard of care imaging. Serious adverse event is defined by ISO 14155.
Composite effectiveness endpoint of procedural and technical success without occurrence of clinically significant pulmonary embolism
Time frame: At 12-months in-situ or 1-month post-retrieval (whichever comes first)
New symptomatic PE confirmed by appropriate imaging
6 secondary outcomes
Mechanical Stability
Time frame: At 3-months, 6-months, 12-months, 18-months, 24-months or at the time of filter retrieval
Procedure-related complications
Time frame: At 3-months
Major adverse events (composite and individual components)
Time frame: At 3-months, 6-months, 12-months, 18-months, and 24-months
Filter tilting >15°
Time frame: At 3-months, 6-months, 12-months, 18-months, 24-months or at the time of filter retrieval
Filter retrieval
Time frame: Up to 24-months
Secondary Effectiveness Endpoint for each IVC filter brand tested only if the study is a success (i.e., both primary safety and effectiveness endpoints have been met)
Time frame: At 12-months
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 4 Oct 2021.
- Derived from this study: PubMed 36872169Johnson MS, Spies JB, Scott KT, Kato BS, Mu X, Rectenwald JE, White RA, Lewandowski RJ, Khaja MS, Zuckerman DA, Casciani T, Gillespie DL. Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE): Outcomes at 12 months. J Vasc Surg Venous Lymphat Disord. 2023 May;11(3):573-585.e6. doi: 10.1016/j.jvsv.2022.11.002. Epub 2023 Feb 23.
- Derived from this study: PubMed 36841633Johnson MS, Spies JB, Scott KT, Kato BS, Mu X, Rectenwald JE, White RA, Lewandowski RJ, Khaja MS, Zuckerman DA, Casciani T, Gillespie DL. Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE): Outcomes at 12 months. J Vasc Interv Radiol. 2023 Apr;34(4):517-528.e6. doi: 10.1016/j.jvir.2022.12.009. Epub 2023 Feb 23.
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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.
David L. Gillespie, MD, FACS study chair
Cape Cod Hospital
Matt Johnson, MD study chair
Indiana University
53 sites 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 and Deep Vein Thrombosis, run by Carelon Research at 53 sites 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 2 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 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites 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?
Composite safety endpoint of freedom from clinically significant perforation after successful filter placement, filter embolization, caval thrombotic occlusion, deep vein thrombosis, and perioperative serious adverse event (time frame: Within first 365 days (± 30 days)). The study lists 2 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 NCT02381509, which also lists 2 linked publications.
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 4 Oct 2021.