Predicting the Safety and Effectiveness of Inferior Vena Cava Filters

Carelon Research1,428 enrolled

Overview

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.

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

1,428

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: At 12-months in-situ or 1-month post-retrieval (whichever comes first)

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: At 3-months, 6-months, 12-months, 18-months, and 24-months

Filter tilting >15°

As determined by appropriate imaging

Time frame: 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

Time frame: 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

Time frame: At 12-months

Predicting the Safety and Effectiveness of Inferior Vena Cava Filters

Overview

Conditions

Interventions

Eligibility

Locations (53)

Outcomes

Primary Outcomes

Secondary Outcomes