Cook IVC Filter Study (CIVC)

Cook Group

Status: Completed

Conditions: Pulmonary Embolism

Treatments: Device: Cook Celect® Vena Cava Filters; Device: Günther Tulip® Vena Cava Filter

Study type: Interventional

Funder types: Industry

Identifiers

NCT02046096

12-018

Details and patient eligibility

About

This prospective, multicenter, double-arm clinical study further evaluated the safety and effectiveness of Cook's commercially available inferior vena cava (IVC) filters (specifically, the Günther Tulip® Vena Cava Filter and Cook Celect® Vena Cava Filters) in patients in need of temporary or permanent IVC filter placement for the prevention of pulmonary embolism (PE).

Enrollment: 473 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Requires temporary or permanent IVC filter placement for the prevention of PE

Exclusion criteria

• Less than 18 years of age
• Known hypersensitivity or contraindication to contrast medium that cannot be adequately premedicated
• Known allergy or sensitivity to cobalt, chromium, or nickel
• Pregnant or planning to become pregnant in the next 12 months
• Patient refuses blood transfusions
• At risk of septic embolism
• Medical condition or disorder that would limit life expectancy to less than 12 months or that may cause noncompliance with the protocol or confound the data analysis
• Existing IVC filter
• Duplicate IVC
• Anatomy that would prevent safe filter placement (e.g., condition of access vessels)
• IVC diameter > 30 mm or < 15 mm

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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473 participants in 2 patient groups

Günther Tulip® Vena Cava Filter

Experimental group

Description:

Günther Tulip® Vena Cava Filter

Treatment:

Device: Günther Tulip® Vena Cava Filter

Cook Celect® Vena Cava Filters

Experimental group

Description:

Cook Celect® Vena Cava Filters

Treatment:

Device: Cook Celect® Vena Cava Filters