Deep Venous ThrombosisNCT03987321
Retrievability and Incidence of Complex Retrieval in Celect Versus Denali Filter
A study testing Infrarenal vena cava filter placement in people with Deep Venous Thrombosis, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Deep Venous Thrombosis
- What is being tested?
- Infrarenal vena cava filter placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2019to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Radiology, Severance hospital, Yonsei College of Medicine
Seoul
Man Deuk Kim, MD, Ph.D, 82-2-2228-7400, mdkim@yuhs.ac
About this study
Official title: Retrievability and Incidence of Complex Retrieval in Celect Versus Denali Filter: A Prospective, Randomized, Comparative Study
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.
Read the 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)
- Conditions
- Deep Venous Thrombosis
- Being tested
- Infrarenal vena cava filter placement
- Keywords
- Inferior vena cava, filter, deep venous thrombosis, pulmonary embolism, complex retrieval
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrarenal vena cava filter placementDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Denali Group | Experimental | Those who received Denali filter placement Receives: Device: Infrarenal vena cava filter placement |
| Celect Group | Experimental | Those who received Celect filter placement Receives: Device: Infrarenal vena cava filter placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complicated filter retrieval
Incidence of retrieval cases that require the use of standard retrieval kit (sheath and snare)
Measured: 2 months after filter placement
Secondary outcomes (5)
Incidence of penetration
Measured: 2 months after filter placement
tilt angle
Measured: 2 months after filter placement
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.
Measured: 2 months after filter placement
fracture
Filter fracture is any loss of a filter's structural integrity(ie, breakage or separation) documented by imaging.
Measured: 2 months after filter placement
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.
Measured: 2 months after filter placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study startJul 2019 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987321
- Sponsor's protocol ID
- 1-2019-0020
- Status last verified
- Jun 2019
- First submitted
- 26 May 2019
- Last updated
- 17 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrievability and Incidence of Complex Retrieval in Celect Versus Denali Filter: A Prospective, Randomized, Comparative Study
- ClinicalTrials.gov ID
- NCT03987321
- Acronym / sponsor ID
- 1-2019-0020
- Conditions
- Deep Venous Thrombosis
- Keywords
- Inferior vena cava, filter, deep venous thrombosis, pulmonary embolism, complex retrieval
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2019 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 17 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients who are enrolled in this study are assigned to receive either Denali or Celect filter in the inferior vena cava.
| Arm | Type | Receives |
|---|---|---|
| Denali Group | Experimental | Device: Infrarenal vena cava filter placementThose who received Denali filter placement |
| Celect Group | Experimental | Device: Infrarenal vena cava filter placementThose who received Celect filter placement |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infrarenal vena cava filter placementPatients 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 | Device | Celect Group, Denali Group |
Primary outcome
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)
5 secondary outcomes
Incidence of penetration
Time frame: 2 months after filter placement
tilt angle
Time frame: 2 months after filter placement
Filter migration
Time frame: 2 months after filter placement
fracture
Time frame: 2 months after filter placement
signs of inferior vena cava occlusion/stenosis
Time frame: 2 months after filter placement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infrarenal vena cava filter placement in people with Deep Venous Thrombosis, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Man Deuk Kim (82-2-2228-7400, mdkim@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of complicated filter retrieval (time frame: 2 months after filter placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2019.