Cook IVC Filter Study

  • Interventional
  • Not Recruiting
  • NCT02046096
Eligibility Details Visit Clinicaltrials.gov

Cook IVC Filter Study

This prospective, multicenter, single-arm clinical study will further evaluate the safety and effectiveness of Cook's permanent and retrievable 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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

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

        Exclusion Criteria:

         - Less than 18 years of age

         - Allergy or sensitivity to device materials or contrast medium

         - Pregnant or planning to become pregnant in the next 12 months

         - Patient refuses blood transfusions

         - At risk of septic embolism

         - Life expectancy less than 12 months

         - 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

At a Glance

National Government IDNCT02046096

IRB#IRB14-0784

Lead SponsorCook Research Incorporated

Lead PhysicianThuong G. Van Ha

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting