ODEN Trial: Option vs. Denali IVC Filters
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | June 2014 |
| End Date: | December 2016 |
Prospective Randomized Evaluation of the Denali and Option Inferior Vena Cava Filters
This research study is a prospective randomized trial evaluating the relative safety of two
inferior vena cava (IVC) filters used to prevent the migration of potentially dangerous
deadly blood clots from the legs to the lung in patients who cannot take blood thinners. All
eligible patients will have been ordered to have a IVC filter placed by their primary
medical team and filters will be placed in these patients whether or not they wish to
participate in this trial as part of standard of care. The investigators will follow up with
patients 30 days after IVC filter placement and ask them to come back for filter removal if
medically appropriate. If removal is not medically appropriate in 30 days, the investigators
will attempt to schedule removal every 30 days after initial placement.
Primary outcome measures will be IVC filter complications such as filter penetration through
the IVC wall and into other organs, filter tilt, filter migration, filter fracture and clots
formed within the filter. All of these are reported complications of all IVC filters.
The research also aims to improve the standard of care for IVC filter patient follow up as
the FDA and Society of Interventional Radiology recommend that IVC filters be removed as
soon as it is safe to do so.
Hypothesis:
The investigators hypothesize that there is no significant difference in efficacy and
complication rate between the Option and the Denali filter.
inferior vena cava (IVC) filters used to prevent the migration of potentially dangerous
deadly blood clots from the legs to the lung in patients who cannot take blood thinners. All
eligible patients will have been ordered to have a IVC filter placed by their primary
medical team and filters will be placed in these patients whether or not they wish to
participate in this trial as part of standard of care. The investigators will follow up with
patients 30 days after IVC filter placement and ask them to come back for filter removal if
medically appropriate. If removal is not medically appropriate in 30 days, the investigators
will attempt to schedule removal every 30 days after initial placement.
Primary outcome measures will be IVC filter complications such as filter penetration through
the IVC wall and into other organs, filter tilt, filter migration, filter fracture and clots
formed within the filter. All of these are reported complications of all IVC filters.
The research also aims to improve the standard of care for IVC filter patient follow up as
the FDA and Society of Interventional Radiology recommend that IVC filters be removed as
soon as it is safe to do so.
Hypothesis:
The investigators hypothesize that there is no significant difference in efficacy and
complication rate between the Option and the Denali filter.
This is a prospective, randomized trial comparing two FDA-approved inferior vena cava
filters, the Denali retrievable IVC filter (Bard Peripheral Vascular Inc., Tempe, AZ) and
the Option Elite (Argon Medical, Athens, Texas).
Patients scheduled for IVC filter placement at UCSF Department of Interventional Radiology
(IR) will be asked by the IR physician performing the procedure at either UCSF Mt. Zion or
Moffitt hospital if they wish to participate in this prospective, randomized study.
Recruitment will be conducted by the physicians performing the IR procedures only. No
additional recruitment calls, emails, posters or web pages are necessary. All procedures and
the randomization to one of the two experimental groups will be carefully explained before
obtaining signed written consent.
Screening:
Screening will be conducted by the IR physician prior to the placement of the IVC filters.
Since this is a standard of care study, patients who are recommended for IVC filter
placement and are scheduled for the procedure are generally eligible.
The screening procedures are part of routine care before IVC filter placement and would be
done even if patients did not join the study.
The study doctor will review the results of most recent routine care imaging scans (CT or
MRI) of the abdomen and pelvis. This is done to confirm that the diameter of IVC is no wider
than 2.8cm. Both filters are FDA-approved to be placed in an IVC with maximal diameter of
2.8cm.
The study doctor will also review ultrasound of the lower extremity, when available, to
confirm that a blood clot was in fact present prior to performing the study. This ensures
that patients who present for IVC filter placement are screened properly.
The following screening procedures should be done within 12 days before the IVC filter
placement procedure as part of the standard of care.
- A complete physical exam
- The study doctor will ask about medical history and how well patient is able to do
daily activities
- Routine care blood tests (about 2 tablespoons) o This is to ensure that the INR and
platelet count of the patient is within the safe limits to perform an invasive
procedure.
After Enrollment:
If the screening procedures show that the patient is eligible and consents to take part in
the study, IVC filter placement will occur after randomization.
After enrollment, the following procedures will be done during the study: Just as with
screening, all of these procedures are part of regular IVC filter placement care.
Randomization:
Randomization will occur on the day of procedure or prior clinic visit with IR physician to
either the Denali or Option IVC filter. All IR attending physicians on the protocol are
familiar with placement of either filter type. Prior to opening study to accrual, 75 sealed
security envelopes with the word Denali printed on a card inside and 75 sealed security
envelopes with the word Option will be assembled by IR staff not involved in the research.
The envelopes will be mixed up and placed in a bag. Computerized randomization programs and
tables were considered but we feel the envelopes will work best as there may be limited time
after patient is consented and procedure begins. This is especially true as some filters are
placed emergently. Previous IR studies have used this randomization technique with great
success.
Filter Placement:
Placement of an IVC filter involves the insertion of a plastic tube (catheter) into a vein
in the neck. Some numbing medicine (Lidocaine) will be injected in the skin over the vein
before the catheter is inserted. Intravenous medications will be given to induce moderate
sedation (Fentanyl for analgesic and Versed for moderate sedation). Once the catheter has
been placed into the vein, it will be advanced into the IVC. Once in correct position, x-ray
contrast material (x-ray dye-Omnipaque 350) will be injected through the catheter and x-ray
pictures taken. A series of x-ray pictures will be obtained of the IVC. These pictures are
taken as part of standard of care to determine the position of the renal veins with respect
to the IVC. The top of the filter must sit below the renal veins so it does not cause
obstruction of the renal veins. In addition, pictures of the IVC are taken to serve as
another tool in measuring the diameter of the IVC to make sure the diameter of the IVC is
less than 2.8cm. This is particularly important in situations when a CT or MRI of the
abdomen and pelvis is not available to have reviewed prior to the procedure. Once pictures
are obtained and it is made certain that the IVC diameter is less than 2.8cm, the filter
will be inserted through the catheter, and placed below the renal veins. During the
placement procedure, positioning of the filter will be monitored with x-ray pictures. At the
completion of the procedure the catheter will be removed and pressure will be applied to the
insertion site until the bleeding has stopped. All of this is part of routine standard of
care for placement of the filter. The doctor performing the procedure will be asked to
complete a short questionnaire after IVC filter placement which will be attached to "Study
Documents".
Follow-Up:
After the IVC filter placement procedure patient status will be followed by the
interventional radiology doctors.
Per standard of care after IVC filter placement, patient will be monitored in the hospital
for up to 1 hour after the procedure. If patient is in stable condition and sedation has
resolved, they will return home the same day or returned to their hospital rooms.
A tentative appointment for follow up and filter retrieval will be ordered by IR physician
at time of filter placement in APEX. This will ensure that scheduling and study staff will
be aware that further patient and primary care follow-up is required.
Patient primary care physician and/or relevant medical staff will be telephoned one month
after IVC filter placement to determine if patient is medically stable and suitable for IVC
filter removal.
If IR and other doctors agree that IVC filter removal is recommended, patient will be
scheduled to return for follow-up imaging and filter retrieval. If patient is not medically
stable or still at high risk for blood clots, we will attempt to schedule a follow up one
month later. Close contact with primary physician and patient will be maintained to ensure
that filter is removed as soon as possible. APEX scheduling will be used to make sure follow
up is performed at regular intervals.
At follow-up appointment these routine tests per standard of care before IVC filter removal
will be performed:
- A physical exam
- The study doctor will ask about medical history, how well patient is able to do daily
activities, and if they are experiencing any possible symptoms related to the IVC
filter placement such as abdominal or back pain.
- A rotation CT focused to the site of the filter will be performed as part of routine
practice of filter removal. This is done to ensure the filter has not migrated or that
the filter has not penetrated through the walls of the IVC such that filter retrieval
would be unsafe.
- IR physician will determine if patient status is stable and safe for IVC filter
removal. If not, physician will discuss with primary care doctor if filter needs to
remain permanently in patient or if later retrieval should be considered at subsequent
follow up visits.
- IVC filter retrieval will be performed under moderate sedation. This procedure is very
similar in nature to the filter placement procedure. The IVC filter is removed via a
similar process to the way in which it was placed. X-ray dye (contrast) will be
injected around the filter to assure that the filter and the area beneath the filter
are free of blood clots and that it is safe to proceed with removal. A catheter-based
snare will be used to engage the hook at the end of the filter and the filter will then
be enveloped by a removal sheath and removed from the body.
filters, the Denali retrievable IVC filter (Bard Peripheral Vascular Inc., Tempe, AZ) and
the Option Elite (Argon Medical, Athens, Texas).
Patients scheduled for IVC filter placement at UCSF Department of Interventional Radiology
(IR) will be asked by the IR physician performing the procedure at either UCSF Mt. Zion or
Moffitt hospital if they wish to participate in this prospective, randomized study.
Recruitment will be conducted by the physicians performing the IR procedures only. No
additional recruitment calls, emails, posters or web pages are necessary. All procedures and
the randomization to one of the two experimental groups will be carefully explained before
obtaining signed written consent.
Screening:
Screening will be conducted by the IR physician prior to the placement of the IVC filters.
Since this is a standard of care study, patients who are recommended for IVC filter
placement and are scheduled for the procedure are generally eligible.
The screening procedures are part of routine care before IVC filter placement and would be
done even if patients did not join the study.
The study doctor will review the results of most recent routine care imaging scans (CT or
MRI) of the abdomen and pelvis. This is done to confirm that the diameter of IVC is no wider
than 2.8cm. Both filters are FDA-approved to be placed in an IVC with maximal diameter of
2.8cm.
The study doctor will also review ultrasound of the lower extremity, when available, to
confirm that a blood clot was in fact present prior to performing the study. This ensures
that patients who present for IVC filter placement are screened properly.
The following screening procedures should be done within 12 days before the IVC filter
placement procedure as part of the standard of care.
- A complete physical exam
- The study doctor will ask about medical history and how well patient is able to do
daily activities
- Routine care blood tests (about 2 tablespoons) o This is to ensure that the INR and
platelet count of the patient is within the safe limits to perform an invasive
procedure.
After Enrollment:
If the screening procedures show that the patient is eligible and consents to take part in
the study, IVC filter placement will occur after randomization.
After enrollment, the following procedures will be done during the study: Just as with
screening, all of these procedures are part of regular IVC filter placement care.
Randomization:
Randomization will occur on the day of procedure or prior clinic visit with IR physician to
either the Denali or Option IVC filter. All IR attending physicians on the protocol are
familiar with placement of either filter type. Prior to opening study to accrual, 75 sealed
security envelopes with the word Denali printed on a card inside and 75 sealed security
envelopes with the word Option will be assembled by IR staff not involved in the research.
The envelopes will be mixed up and placed in a bag. Computerized randomization programs and
tables were considered but we feel the envelopes will work best as there may be limited time
after patient is consented and procedure begins. This is especially true as some filters are
placed emergently. Previous IR studies have used this randomization technique with great
success.
Filter Placement:
Placement of an IVC filter involves the insertion of a plastic tube (catheter) into a vein
in the neck. Some numbing medicine (Lidocaine) will be injected in the skin over the vein
before the catheter is inserted. Intravenous medications will be given to induce moderate
sedation (Fentanyl for analgesic and Versed for moderate sedation). Once the catheter has
been placed into the vein, it will be advanced into the IVC. Once in correct position, x-ray
contrast material (x-ray dye-Omnipaque 350) will be injected through the catheter and x-ray
pictures taken. A series of x-ray pictures will be obtained of the IVC. These pictures are
taken as part of standard of care to determine the position of the renal veins with respect
to the IVC. The top of the filter must sit below the renal veins so it does not cause
obstruction of the renal veins. In addition, pictures of the IVC are taken to serve as
another tool in measuring the diameter of the IVC to make sure the diameter of the IVC is
less than 2.8cm. This is particularly important in situations when a CT or MRI of the
abdomen and pelvis is not available to have reviewed prior to the procedure. Once pictures
are obtained and it is made certain that the IVC diameter is less than 2.8cm, the filter
will be inserted through the catheter, and placed below the renal veins. During the
placement procedure, positioning of the filter will be monitored with x-ray pictures. At the
completion of the procedure the catheter will be removed and pressure will be applied to the
insertion site until the bleeding has stopped. All of this is part of routine standard of
care for placement of the filter. The doctor performing the procedure will be asked to
complete a short questionnaire after IVC filter placement which will be attached to "Study
Documents".
Follow-Up:
After the IVC filter placement procedure patient status will be followed by the
interventional radiology doctors.
Per standard of care after IVC filter placement, patient will be monitored in the hospital
for up to 1 hour after the procedure. If patient is in stable condition and sedation has
resolved, they will return home the same day or returned to their hospital rooms.
A tentative appointment for follow up and filter retrieval will be ordered by IR physician
at time of filter placement in APEX. This will ensure that scheduling and study staff will
be aware that further patient and primary care follow-up is required.
Patient primary care physician and/or relevant medical staff will be telephoned one month
after IVC filter placement to determine if patient is medically stable and suitable for IVC
filter removal.
If IR and other doctors agree that IVC filter removal is recommended, patient will be
scheduled to return for follow-up imaging and filter retrieval. If patient is not medically
stable or still at high risk for blood clots, we will attempt to schedule a follow up one
month later. Close contact with primary physician and patient will be maintained to ensure
that filter is removed as soon as possible. APEX scheduling will be used to make sure follow
up is performed at regular intervals.
At follow-up appointment these routine tests per standard of care before IVC filter removal
will be performed:
- A physical exam
- The study doctor will ask about medical history, how well patient is able to do daily
activities, and if they are experiencing any possible symptoms related to the IVC
filter placement such as abdominal or back pain.
- A rotation CT focused to the site of the filter will be performed as part of routine
practice of filter removal. This is done to ensure the filter has not migrated or that
the filter has not penetrated through the walls of the IVC such that filter retrieval
would be unsafe.
- IR physician will determine if patient status is stable and safe for IVC filter
removal. If not, physician will discuss with primary care doctor if filter needs to
remain permanently in patient or if later retrieval should be considered at subsequent
follow up visits.
- IVC filter retrieval will be performed under moderate sedation. This procedure is very
similar in nature to the filter placement procedure. The IVC filter is removed via a
similar process to the way in which it was placed. X-ray dye (contrast) will be
injected around the filter to assure that the filter and the area beneath the filter
are free of blood clots and that it is safe to proceed with removal. A catheter-based
snare will be used to engage the hook at the end of the filter and the filter will then
be enveloped by a removal sheath and removed from the body.
Inclusion Criteria:
1. Patients scheduled for IVC filter placement at UCSF Moffitt and Mount Zion hospitals
Interventional Radiology
2. 18+
Exclusion Criteria:
1. Necessity of permanent IVC filter
2. Genetic or physical abnormalities of the inferior vena cava
3. Circumstances that in the opinion of the primary investigator, patient would be a
poor candidate either due to complications in medical condition or lack of ability
for follow up. (I.E. PI discretion)
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