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Retrievability and Incidence of Complex Retrieval in Celect Versus Denali Filter

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ClinicalTrials.gov Identifier: NCT03987321
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Deep Venous Thrombosis Device: Infrarenal vena cava filter placement Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients who are enrolled in this study are assigned to receive either Denali or Celect filter in the inferior vena cava.
Masking: Single (Participant)
Masking Description: Participants are blinded to the filter type.
Primary Purpose: Treatment
Official Title: Retrievability and Incidence of Complex Retrieval in Celect Versus Denali Filter: A Prospective, Randomized, Comparative Study
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Denali Group
Those who received Denali filter placement
Device: Infrarenal vena cava filter placement
Patients who are enrolled in this study are assigned to receive either Denali or Celect filter in the inferior vena cava. All other procedures are the same in both groups

Experimental: Celect Group
Those who received Celect filter placement
Device: Infrarenal vena cava filter placement
Patients who are enrolled in this study are assigned to receive either Denali or Celect filter in the inferior vena cava. All other procedures are the same in both groups




Primary Outcome Measures :
  1. Incidence of complicated filter retrieval [ Time Frame: 2 months after filter placement ]
    Incidence of retrieval cases that require the use of standard retrieval kit (sheath and snare)


Secondary Outcome Measures :
  1. Incidence of penetration [ Time Frame: 2 months after filter placement ]
  2. tilt angle [ Time Frame: 2 months after filter placement ]
  3. Filter migration [ Time Frame: 2 months after filter placement ]
    Filter migration is a change in filter position com-pared with its deployed position (cranial or caudal) of more than 2 cm as documented by diagnostic imaging.

  4. fracture [ Time Frame: 2 months after filter placement ]
    Filter fracture is any loss of a filter's structural integrity(ie, breakage or separation) documented by imaging.

  5. signs of inferior vena cava occlusion/stenosis [ Time Frame: 2 months after filter placement ]
    Any signs of narrowing or obstruction of the IVC where the IVC filter was inserted as documented by CT.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987321


Contacts
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Contact: Man Deuk Kim 82-2-2228-7400 mdkim@yuhs.ac

Locations
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Korea, Republic of
Department of Radiology, Severance hospital, Yonsei College of Medicine Recruiting
Seoul, Korea, Republic of
Contact: Man Deuk Kim, MD, Ph.D    82-2-2228-7400    mdkim@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03987321     History of Changes
Other Study ID Numbers: 1-2019-0020
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yonsei University:
Inferior vena cava
filter
deep venous thrombosis
pulmonary embolism
complex retrieval

Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases