Cook IVC filter Study (12-018)

  • Research type

    Research Study

  • Full title

    Cook IVC filter Study (Global Clinical study number 12-018)

  • IRAS ID

    139000

  • Contact name

    Anna Bjerg Jessen

  • Contact email

    Anna.Jessen@CookMedical.com

  • Sponsor organisation

    Wiliam Cook Europe ApS

  • Clinicaltrials.gov Identifier

    NCT02046096

  • Research summary

    Pulmonary embolism (PE) is a major cause of morbidity and mortality. Pulmonary embolism is a blockage of the main artery of the lung or one of its branches. PE most commonly results from a blood clot in the deep veins of the legs or pelvis that breaks off and migrates to the lung.
    Populations at an increased risk include amongst others those with an inherited increased risk of blood clots, those undergoing complex surgery, those with cancer, trauma, prolonged immobilization, patients with acute medical situations such as stroke, heart failure, respiratory failure, or infections. The typical prevention method is anticoagulation therapy. However, this treatment may be contraindicated in some patients. Therefore, filter placement is frequently used to mitigate the potential risk of pulmonary embolism.
    This prospective, multicenter, single-arm clinical study will further evaluate the safety and effectiveness of Cook’s permanent and retrievable inferior vena cava filters (specifically, the Günther Tulip® and the Cook Celect® filters) in patients in need of temporary or permanent treatment for the prevention of pulmonary embolism. This study will enroll 320 patients in the Celect® filter stratum and up to 150 in the Günther Tulip® stratum at up to 40 clinical sites globally. The choice of what filter to place is left to the discretion of the physician. Enrollment will cease when the necessary number of patients have been enrolled in the Celect stratum. The study will evaluate the performance and safety of filters in patients considered at risk for PE for a variety of clinical reasons (i.e. a broad patient population). Patients will be followed until 1) 3 months after successful filter retrieval (follow up at 1 and 3 months after retrieval) or 2) until study completion 2 years after filter placement (follow up at 1,3,6,12,18,24 months after placement).

  • REC name

    London - Stanmore Research Ethics Committee

  • REC reference

    14/LO/1611

  • Date of REC Opinion

    19 Nov 2014

  • REC opinion

    Further Information Favourable Opinion