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

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ClinicalTrials.gov Identifier: NCT02381509
Recruitment Status : Recruiting
First Posted : March 6, 2015
Last Update Posted : February 26, 2018
Sponsor:
Collaborators:
IVC Filter Study Group Foundation (IDE Sponsor)
ALN Implants Chirurgicaux
B. Braun Interventional Systems, Inc
Bard Peripheral Vascular, Inc.
Cook Group Incorporated
Cordis Corporation
Rex Medical
Information provided by (Responsible Party):
New England Research Institutes

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 approximately 1,800 IVC filter subjects at up to 60 sites in the US. All treated subjects will be evaluated at procedure, 3-months, 6-months (phone), 12-months, 18-months (phone), and 24-months post-procedure. 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 Device: IVC Filter

Study Design
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Study Type : Observational
Estimated Enrollment : 1800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predicting the Safety and Effectiveness of Inferior Vena Cava Filters
Study Start Date : October 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2019

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U.S. FDA Resources

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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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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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


Contacts
Contact: Olivia Wheaton, BA 617-972-3082 owheaton@neriscience.com
Contact: Sandi Siami, MPH ssiami@neriscience.com

  Show 53 Study Locations
Sponsors and Collaborators
New England Research Institutes
IVC Filter Study Group Foundation (IDE Sponsor)
ALN Implants Chirurgicaux
B. Braun Interventional Systems, Inc
Bard Peripheral Vascular, Inc.
Cook Group Incorporated
Cordis Corporation
Rex Medical
Investigators
Study Chair: David L. Gillespie, MD, RVT, FACS Southcoast Health System
Study Chair: Matt Johnson, MD Indiana University School of Medicine
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT02381509     History of Changes
Other Study ID Numbers: M01482
First Posted: March 6, 2015    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: October 2015

Keywords provided by New England Research Institutes:
inferior vena cava filters

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases