Clinical trial NCT03987321: Retrievability and Incidence of Complex Retrieval in Celect Versus Denali Filter
Official title: Retrievability and Incidence of Complex Retrieval in Celect Versus Denali Filter: A Prospective, Randomized, Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deep Venous Thrombosis
Keywords: Inferior vena cava
filter
deep venous thrombosis
pulmonary embolism
complex retrieval
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients who are enrolled in this study are assigned to receive either Denali or Celect filter in the inferior vena cava.
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to compare the Celect and Denali filters in terms of complicated filter retrieval and indwelling complications after a 2-month indwelling time.

Detailed description: With anticoagulation being the standard treatment for deep venous thrombosis and pulmonary embolism, inferior vena cava filter placement plays an important role in patients who are amenable to anticoagulant therapy. Currently, many different types of retrievable filters are being used in clinical practice and the choice of the filters depends on operators' preference and institutional availability. Each filter has different designs to maximize retrievability and minimize indwelling complications. Up until now, the prior studies on the filter retrievability and indwelling complications have been retrospective in nature and had relatively long dwell times. Comparative data regarding the retrievability of the inferior vena cava filters may help to choose filter selection. Therefore, the aim of this trial is to compare two commonly used inferior vena cava filters (Denali and Celet filters)

Eligibility criteria: Inclusion Criteria:

* 1. Patients who develop deep venous thrombosis and/or pulmonary embolism but are good candidates for anticoagulant therapy
* 2. Inferior vena cava filtration before mechanical thrombectomy for deep venous thrombosis
* 3. Prophylactic filter placement because of trauma or major surgery

Exclusion Criteria:

* 1. Sepsis
* 2. Those who need permanent filter placement
* 3. Congenital anatomical anomaly (IVC duplication, interrupted IVC)
* 4. patients who need filter placement in the suprarenal inferior vena cava

Primary outcomes:
measure: Incidence of complicated filter retrieval
timeFrame: 2 months after filter placement
Secondary outcomes:
measure: Incidence of penetration
timeFrame: 2 months after filter placement
measure: tilt angle
timeFrame: 2 months after filter placement
measure: Filter migration
timeFrame: 2 months after filter placement
measure: fracture
timeFrame: 2 months after filter placement
measure: signs of inferior vena cava occlusion/stenosis
timeFrame: 2 months after filter placement
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Radiology, Severance hospital, Yonsei College of Medicine
Study officials:
References: