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

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.

Study Overview

• Status: Completed
• Conditions: Deep Vein Thrombosis; Pulmonary Embolism
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 1428

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas
  • California
    • Los Angeles, California, United States, 90024
      • Ronald Regan UCLA Medical Center
    • Palo Alto, California, United States, 94304
      • Palo Alto VA
    • San Francisco, California, United States, 94118
      • University of California San Francisco
    • Torrance, California, United States, 90502
      • Harbor-UCLA Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • Connecticut
    • New Haven, Connecticut, United States, 06501
      • Yale New Haven Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • MedStar Georgetown
  • Florida
    • Fort Lauderdale, Florida, United States, 33301
      • Holy Cross Hospital
    • Largo, Florida, United States, 33770
      • The Heart Institute Largo
    • Miami, Florida, United States, 33136
      • University of Miami Hospital and Clinics/Jackson Memorial
    • Orlando, Florida, United States, 32803
      • Florida Hospital
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital
    • Tallahassee, Florida, United States, 32308
      • Tallahasse Memorial Hospital
    • West Palm Beach, Florida, United States, 33407
      • St. Mary's Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Urbana, Illinois, United States, 61801
      • Carle Heart & Vascular Institute
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Louisiana
    • Shreveport, Louisiana, United States, 71130
      • LSU Health Sciences Center at Shreveport
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • Boston, Massachusetts, United States, 02446
      • Massachusetts General Hospital
    • North Dartmouth, Massachusetts, United States, 02747
      • Southcoast Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
    • Saint Louis, Missouri, United States, 63110
      • St. Louis University
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack UMC
    • Summit, New Jersey, United States, 07901
      • Overlook Medical Center
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • Manhasset, New York, United States, 11030
      • Feinstein Institute
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
    • New York, New York, United States, 10065
      • NY Presbyterian Weil Cornell Medical Ctr
    • Rochester, New York, United States, 14621
      • Rochester Regional Health System
    • Syracuse, New York, United States, 13210
      • University Hospital/SUNY Upstate
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
    • Durham, North Carolina, United States, 27710
      • Duke Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Dayton, Ohio, United States, 45409
      • Miami Valley Hospital/Wright State University
    • Lancaster, Ohio, United States, 43130
      • Fairfield Medical Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • University of Oklahoma-Tulsa
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital/Miriam Hospital
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Regional Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern
    • Houston, Texas, United States, 77030
      • Memorial Hermann Hospital
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of WI/Froedtert Memorial Lutheran Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects requiring the placement of one of 6 IVC filters for the prevention of PE.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IVC Filter; IVC filter for the prevention of PE	Device: IVC Filter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	At 12-months in-situ or 1-month post-retrieval (whichever comes first)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	At 3-months, 6-months, 12-months, 18-months, and 24-months
Filter tilting >15°	As determined by appropriate imaging	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	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	At 12-months

Collaborators and Investigators

• Sponsor: HealthCore-NERI
• Collaborators: Cordis Corporation; Cook Group Incorporated; Society for Vascular Surgery; ALN Implants Chirurgicaux; B. Braun Interventional Systems, Inc; Bard Peripheral Vascular, Inc.; Argon Medical Devices; Society of Interventional Radiology Foundation
• Investigators: Study Chair: David L. Gillespie, MD, FACS, Cape Cod Hospital; Study Chair: Matt Johnson, MD, Indiana University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): March 17, 2020
• Study Completion (Actual): September 20, 2021

Study Registration Dates

• First Submitted: March 2, 2015
• First Submitted That Met QC Criteria: March 2, 2015
• First Posted (Estimate): March 6, 2015

Study Record Updates

• Last Update Posted (Actual): October 4, 2021
• Last Update Submitted That Met QC Criteria: September 30, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: inferior vena cava filters
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Thrombosis; Venous Thrombosis; Pulmonary Embolism
• Other Study ID Numbers: M01482

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No