Predicting the Safety and Effectiveness of Inferior Vena Cava Filters

Predicting the Safety and Effectiveness of Inferior Vena Cava Filters

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.

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