Predicting the Safety and Effectiveness of Inferior Vena Cava Filters

ID: NCT02381509
Status: Recruiting
Phase: N/A
Start Date: October 01, 2015
First Submitted: March 02, 2015
Last Updated: February 23, 2018
Results: N/A
Sponsors & Collaborators: New England Research Institutes, IVC Filter Study Group Foundation (IDE Sponsor), ALN Implants Chirurgicaux, B. Braun Interventional Systems, Inc and 5 more..
Location: United States
Conditions: Pulmonary Embolism
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Study Description

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Pulmonary Embolism

Device: IVC Filter
Other Names
N/A

Tracking Information

First Submitted DateMarch 02, 2015
Last Update Posted DateFebruary 23, 2018
Start DateOctober 01, 2015
Anticipated Completion DateMay 01, 2019
Primary Completion DateMay 01, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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)]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitlePredicting the Safety and Effectiveness of Inferior Vena Cava Filters
Official TitlePredicting the Safety and Effectiveness of Inferior Vena Cava Filters
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.

Detailed Description

Study TypeObservational
Study PhaseN/A
Estimated Enrollment
1800
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Pulmonary Embolism
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodNon-Probability Sample
Study PopulationSubjects requiring the placement of one of 6 IVC filters for the prevention of PE.
Intervention
Device: IVC Filter

Other Names
Study Groups/Cohorts
IVC Filter
IVC filter for the prevention of PE

Study Arms
IVC Filter
IVC filter for the prevention of PE
Device : IVC Filter

Arm Intervention/Treatment
IVC Filter
IVC filter for the prevention of PE
Device : IVC Filter

Recruitment Information

Recruitment Status:Recruiting
Enrollment1800
Completion DateMay 01, 2019
Eligibility 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
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT02381509
Other Study ID Numbers
M01482
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
New England Research Institutes
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
Investigators
Study Chair
David L. Gillespie, MD, RVT, FACS
Southcoast Health System
Study Chair
Matt Johnson, MD
Indiana University School of Medicine