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Retrievability and Incidence of Complex Retrieval in Celect Versus Denali Filter

Primary Purpose

Deep Venous Thrombosis

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Infrarenal vena cava filter placement

About this trial

This is an interventional treatment trial for Deep Venous Thrombosis focused on measuring Inferior vena cava, filter, deep venous thrombosis, pulmonary embolism, complex retrieval

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Radiology, Severance hospital, Yonsei College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Denali Group

Celect Group

Arm Description

Those who received Denali filter placement

Those who received Celect filter placement

Outcomes

Primary Outcome Measures

Incidence of complicated filter retrieval

Incidence of retrieval cases that require the use of standard retrieval kit (sheath and snare)

Secondary Outcome Measures

Incidence of penetration

tilt angle

Filter migration

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.

fracture

Filter fracture is any loss of a filter's structural integrity(ie, breakage or separation) documented by imaging.

signs of inferior vena cava occlusion/stenosis

Any signs of narrowing or obstruction of the IVC where the IVC filter was inserted as documented by CT.

Full Information

NCT ID

NCT03987321

First Posted

May 26, 2019

Last Updated

June 13, 2019

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT03987321

Brief Title

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

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Unknown status

Study Start Date

July 2019 (Anticipated)

Primary Completion Date

May 2020 (Anticipated)

Study Completion Date

June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Deep Venous Thrombosis

Keywords

Inferior vena cava, filter, deep venous thrombosis, pulmonary embolism, complex retrieval

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Patients who are enrolled in this study are assigned to receive either Denali or Celect filter in the inferior vena cava.

Masking

Participant

Masking Description

Participants are blinded to the filter type.

Allocation

Randomized

Enrollment

174 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Denali Group

Arm Type

Experimental

Arm Description

Those who received Denali filter placement

Arm Title

Celect Group

Arm Type

Experimental

Arm Description

Those who received Celect filter placement

Intervention Type

Device

Intervention Name(s)

Infrarenal vena cava filter placement

Intervention Description

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 Measure Information:

Title

Incidence of complicated filter retrieval

Description

Incidence of retrieval cases that require the use of standard retrieval kit (sheath and snare)

Time Frame