Predicting the Safety and Effectiveness of Inferior Vena Cava Filters

Pulmonary Embolism Clinical Trial

— PRESERVE  

Official title:

Predicting the Safety and Effectiveness of Inferior Vena Cava Filters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02381509
• Other study ID #: M01482
• Status: Completed
• Start date: October 2015
• Est. completion date: September 20, 2021

Study information

• Verified date: September 2021
• Source: HealthCore-NERI
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1428
• Est. completion date: September 20, 2021
• Est. primary completion date: March 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

Intervention

Device:
• IVC Filter

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Colorado	Aurora	Colorado
United States	Boston Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	UT Southwestern	Dallas	Texas
United States	Miami Valley Hospital/Wright State University	Dayton	Ohio
United States	Duke Medical Center	Durham	North Carolina
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Holy Cross Hospital	Fort Lauderdale	Florida
United States	Hackensack UMC	Hackensack	New Jersey
United States	Memorial Hermann Hospital	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Fairfield Medical Center	Lancaster	Ohio
United States	The Heart Institute Largo	Largo	Florida
United States	University of Arkansas	Little Rock	Arkansas
United States	Ronald Regan UCLA Medical Center	Los Angeles	California
United States	Feinstein Institute	Manhasset	New York
United States	University of Miami Hospital and Clinics/Jackson Memorial	Miami	Florida
United States	Medical College of WI/Froedtert Memorial Lutheran Hospital	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Mount Sinai Hospital	New York	New York
United States	NY Presbyterian Weil Cornell Medical Ctr	New York	New York
United States	Southcoast Hospital	North Dartmouth	Massachusetts
United States	Florida Hospital	Orlando	Florida
United States	Palo Alto VA	Palo Alto	California
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Oregon Health & Science Center	Portland	Oregon
United States	Rhode Island Hospital/Miriam Hospital	Providence	Rhode Island
United States	Mayo Clinic	Rochester	Minnesota
United States	Rochester Regional Health System	Rochester	New York
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	St. Louis University	Saint Louis	Missouri
United States	Washington University	Saint Louis	Missouri
United States	University of California San Francisco	San Francisco	California
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	LSU Health Sciences Center at Shreveport	Shreveport	Louisiana
United States	Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Overlook Medical Center	Summit	New Jersey
United States	University Hospital/SUNY Upstate	Syracuse	New York
United States	Tallahasse Memorial Hospital	Tallahassee	Florida
United States	Harbor-UCLA Medical Center	Torrance	California
United States	University of Oklahoma-Tulsa	Tulsa	Oklahoma
United States	Carle Heart & Vascular Institute	Urbana	Illinois
United States	Medstar Georgetown	Washington	District of Columbia
United States	St. Mary's Medical Center	West Palm Beach	Florida
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (9)

Lead Sponsor	Collaborator
HealthCore-NERI	ALN Implants Chirurgicaux, Argon Medical Devices, B. Braun Interventional Systems, Inc, Bard Peripheral Vascular, Inc., Cook Group Incorporated, Cordis Corporation, Society for Vascular Surgery, Society of Interventional Radiology Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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
Secondary	Procedure-related complications	In the judgment of the Principal Investigator	At 3-months
Secondary	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
Secondary	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
Secondary	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	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