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Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02381509
Recruitment Status : Completed
First Posted : March 6, 2015
Last Update Posted : October 4, 2021
Sponsor:
Collaborators:
ALN Implants Chirurgicaux
B. Braun Interventional Systems, Inc
Bard Peripheral Vascular, Inc.
Cook Group Incorporated
Cordis Corporation
Argon Medical Devices
Society of Interventional Radiology Foundation
Society for Vascular Surgery
Information provided by (Responsible Party):
HealthCore-NERI

Study Description
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Brief 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). 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.

Condition or disease Intervention/treatment
Pulmonary Embolism Deep Vein Thrombosis Device: 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:

  1. ALN Vena Cava Filter (with and without hook) (ALN Implants Chirurgicaux)
  2. Option™ Elite Retrievable Vena Cava Filter (Argon Medical Devices Inc., designed and manufactured by Rex Medical)
  3. VenaTech® LP Vena Cava Filter (B Braun Interventional Systems, Inc.) and VenaTech® Convertible™ Vena Cava Filter
  4. DENALI® Vena Cava Filter System (DL900F, DL900J) (Bard Peripheral Vascular, Inc.)
  5. Cook Günther-Tulip™ Vena Cava Filter (Cook Incorporated)
  6. 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
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Study Type : Observational
Actual Enrollment : 1428 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predicting the Safety and Effectiveness of Inferior Vena Cava Filters
Actual Study Start Date : October 2015
Actual Primary Completion Date : March 17, 2020
Actual Study Completion Date : September 20, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
IVC Filter
IVC filter for the prevention of PE
 Device: IVC Filter


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. Mechanical Stability [ Time Frame: At 3-months, 6-months, 12-months, 18-months, 24-months or at the time of filter retrieval ]
    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

  2. Procedure-related complications [ Time Frame: At 3-months ]
    In the judgment of the Principal Investigator

  3. Major adverse events (composite and individual components) [ Time Frame: At 3-months, 6-months, 12-months, 18-months, and 24-months ]
    Defined as death, PE, caval thrombotic occlusion, DVT, clinically significant perforation, retroperitoneal hematoma, or adjacent organ penetration

  4. Filter tilting >15° [ Time Frame: At 3-months, 6-months, 12-months, 18-months, 24-months or at the time of filter retrieval ]
    As determined by appropriate imaging

  5. Filter retrieval [ Time Frame: Up to 24-months ]
    Includes: Attempted retrieval, Successful retrieval, Failed retrieval, Percentage of retrieval success, Complications associated with filter retrieval, Reasons for failed retrieval

  6. 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 ]
    PE rate


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects requiring the placement of one of 6 IVC filters for the prevention of PE.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02381509


Locations
Show Show 53 study locations
Sponsors and Collaborators
HealthCore-NERI
ALN Implants Chirurgicaux
B. Braun Interventional Systems, Inc
Bard Peripheral Vascular, Inc.
Cook Group Incorporated
Cordis Corporation
Argon Medical Devices
Society of Interventional Radiology Foundation
Society for Vascular Surgery
Investigators
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Study Chair: David L. Gillespie, MD, FACS Cape Cod Hospital
Study Chair: Matt Johnson, MD Indiana University School of Medicine
More Information
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Responsible Party: HealthCore-NERI
ClinicalTrials.gov Identifier: NCT02381509    
Other Study ID Numbers: M01482
First Posted: March 6, 2015    Key Record Dates
Last Update Posted: October 4, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by HealthCore-NERI:
inferior vena cava filters
Additional relevant MeSH terms:
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Pulmonary Embolism
Thrombosis
Embolism
Venous Thrombosis
Embolism and Thrombosis
 Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases