Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00163956
Status:
UNKNOWN
Last Update Posted:
2006-10-04
First Post:
2005-09-12
Brief Title:
Failed Retrieval of Inferior Vena Cava IVC Filters Long-Term Outcomes
Sponsor:
Bayside Health
Organization:
Bayside Health
Study Overview
Official Title:
Failed Retrieval of Inferior Vena Cava IVC Filters Long-Term Outcomes
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The inferior vena cava IVC is a large vein that enters the bottom part of the heart Venous blood from the lower portion of the body drains into the IVC The IVC then returns blood back to the heart An IVC filter is placed to help prevent the blood clots moving from the legs to the heart or lung The idea behind using a filter in the IVC is to capture potential fatal pulmonary emboli at an anatomical location where they may pose less risk for the patient Early filters 1960s and 70s were remained in the vein permanently More recently temporary or retrievable filters have been developed and are being widely used
Complications have been demonstrated with long-term placement of IVC filters In a randomised study it was found that that patients with IVC filter placement had greater than three times the incidence of recurrent deep vein thrombosis DVT compared to their control population at two years Blockage of the vein recurrent pulmonary emboli filter penetration and filter fragmentation have all been described
With the advent of retrievable filters filters that can be place temporarily and then removed at a later date there has been renewed popularity for placement of temporary filters To our knowledge no one has yet to follow the population of intended temporary IVC filters who undergo failed retrieval and consequently end up with a permanent IVC filter
We plan to prospectively enrol 40 Alfred patients who have undergone a temporary IVC filter placement and subsequently have had failed IVC filter retrieval
Our aim is to evaluate the long term outcomes for patients with failed IVC retrieval
Specifically we will determine the risk due to failed filter retrieval of
IVC stenosis
IVC occlusion
Development of DVT and
analyse the clinical outcomes symptoms their prevalence and their distribution
Patients will receive routine care and their data will be analysed annually as collected The follow-up period is indefinite and will be at the discretion of the treating doctor
Complications have been demonstrated with long-term placement of IVC filters In a randomised study it was found that that patients with IVC filter placement had greater than three times the incidence of recurrent deep vein thrombosis DVT compared to their control population at two years Blockage of the vein recurrent pulmonary emboli filter penetration and filter fragmentation have all been described
With the advent of retrievable filters filters that can be place temporarily and then removed at a later date there has been renewed popularity for placement of temporary filters To our knowledge no one has yet to follow the population of intended temporary IVC filters who undergo failed retrieval and consequently end up with a permanent IVC filter
We plan to prospectively enrol 40 Alfred patients who have undergone a temporary IVC filter placement and subsequently have had failed IVC filter retrieval
Our aim is to evaluate the long term outcomes for patients with failed IVC retrieval
Specifically we will determine the risk due to failed filter retrieval of
IVC stenosis
IVC occlusion
Development of DVT and
analyse the clinical outcomes symptoms their prevalence and their distribution
Patients will receive routine care and their data will be analysed annually as collected The follow-up period is indefinite and will be at the discretion of the treating doctor
Detailed Description:
Clinical Study Protocol
Failed Retrieval of Inferior Vena Cava IVC filters long-term outcomes
Study Objective To evaluate the long term outcomes for failed IVC retrieval
Background Long-term placement of IVC filters is not without complication Descosous et al demonstrated that those patients with IVC filter placement had greater than three times the incidence of recurrent DVT at two years Pulmonary Emboli PE have been reported These can occur when there is no evidence of PE prior to insertion of the IVC filter This was shown by Rogers et al where 23 of trauma patients receiving prophylactic filters developed a PE They can also occur as a recurrence ie where a PE has already been demonstrated prior IVC filter insertion in 25 to 77 of patients1 2
Caval thrombosis resulting in occlusion have been reported to occur in between 1-24 of cases depending on the type of filter3 4 Guidewire and catheter entrapment during central venous and pulmonary artery catheter placement have also been reported as long term IVC filters become more prevalent Filter penetration and filter fragmentation have all been described
With the advent of retrievable filters there is renewed popularity for temporary caval interruption To our knowledge no one has yet to follow the population of intended temporary caval interruption who undergo failed retrieval and consequently end up with a permanent IVC filter This study will look at the incidence and degree of caval occlusion caval stenosis and incidence of DVT in patients at The Alfred who have had a failed retrieval of an implanted IVC filter Patient will be recruited for up to four years the incidence of failed retrieval at The Alfred is 10 per year and follow up will be ongoing
Patient Population Alfred patients undergoing temporary IVC filter placement and subsequently have had failed IVC filter retrieval
Study Design This is a prospective single-arm study
Patients identified with failed filter retrieval will be asked to participate in the study They will have a CT cavagram and lower limb duplex doppler ultrasound annually which is part of standard patient management practice
Clinical evaluation history-taking and examination for filter complications and venous hypertension will be conducted annually again as part of standard patient management
Data will be collected as per data collection forms and analysed
Enrolment Size 40 patients will be enrolled
Primary End-Points CT cavagram will be used to evaluatemeasure
Caval occlusion
Caval stenosis
Chronic or acute DVT will be evaluated with
Duplex sonography
Secondary End-points Adverse events related to IVC filter as established through
Physical examination
Patient interview
Research Plan
Specific Aim
To evaluate the long term outcomes for failed IVC retrieval
Objectives
To determine the risk of IVC stenosis due to failed filter retrieval
To determine the risk of IVC occlusion due to failed filter retrieval
To identify the risk of DVT due to failed filter retrieval
To analyse the clinical outcomes symptoms their prevalence and their distribution produced as a result of failed filter retrieval
Research Design and Methods
This is a prospective single-arm clinical study An will be made to the HREC to obtain ethics approval for this study Participants will be enrolled consecutively
Patients will receive routine care and their data will be analysed annually as collected The follow-up period is indefinite and will be at the discretion of the treating doctor
The data from the CT cavagram and duplex Doppler will be collected by the research assistant from the patients histories and reported onto the Investigations data sheet see Appendix I
The data from the clinical interview and examination will be collected from the patients histories and reported onto the Examination data sheet see Appendix II
Analysis Plan and Statistical Methods
This study will look at the incidence and degree of caval occlusion caval stenosis and incidence of DVT in patients at The Alfred who have had a failed retrieval of an implanted IVC filter
Data management quality control Non-identifiable information will be collected and securely stored in the Radiology Department research office Data will be entered into an excel spreadsheet and the incidence of the primary and secondary endpoints summarised
Complications and Reporting of Adverse Events
There are no direct medical complications that might arise due to participation in this trial as patients will have routine care This study involves data collection and no change to routine management Any adverse event in reporting identifiable data will be reported to the HREC committee within 24 hours from the identification of the event
Complications resulting from the CT cavagram include
Contrast Allergy
Anaphylaxis
Infection
Adverse events therefore relate principally to confidentiality See Data Management below for procedures related to adverse event reporting for breach of confidentiality
Data Management
Data will be collated stored and analysed by the research coordinator Dr Helen Kavnoudias
All data forms will be de-identified prior to reporting andor publication of results
Patient medical records will be appropriately labelled as participants of research study and kept indefinitely
All departmental procedures relating to research ethics and privacy regulations will be adhered to
Adverse events involving data management will be reported to the ethics committee with 24-hours by the research team
Time-frame
This research will be ongoing There are approximately 10 failed retrievals each year
References
1 Wolf F Thurnher S Lammer J Simon nitinol vena cava filters Effectiveness and complications Rofo Fortschr Geb Rontgenstr Neuen Bildgeb Verfahr 2001 173 924-30
2 Harries SR Wells IP Roobottom VA Long term follow up of the antheor interior vena cava filter Clin Radiol 1998 53 350-2
3 Millward SF Peterson RA Moher D et al LGM Vena Tech vena caval filter Experience at a single institution J Vase Interv Radiol 1994 5351-6
4 Greenfield LJ Proctor MC Cho KJ et al Extended evaluations of the titanium Greenfield vena caval filter J Vasc Surg 1996 20 458-65
Appendix I
Investigations
Date Follow-Up
Name
Sex
Age
UR
CT Cavagram Is there occlusion of the IVC Yes No Is there 50 stenosis of the IVC Yes No
Is there 20 stenosis of the IVC Yes No
Duplex Doppler Is there presence of thrombus Yes No
If yes where
Is the thrombus Acute Chronic
Appendix II
Examination
Date Follow-Up
Name
Sex
Age
UR
Does the patient suffer from any of the following
please tick ٱLower limb venous incompetence ٱ Chronic limb pain ٱ Oedema ٱ Discolouration ٱ Ulceration ٱ Historical episodes of DVT ٱ PE ٱ Filter-fragmentation embolisation
CEAP Score
Failed Retrieval of Inferior Vena Cava IVC filters long-term outcomes
Study Objective To evaluate the long term outcomes for failed IVC retrieval
Background Long-term placement of IVC filters is not without complication Descosous et al demonstrated that those patients with IVC filter placement had greater than three times the incidence of recurrent DVT at two years Pulmonary Emboli PE have been reported These can occur when there is no evidence of PE prior to insertion of the IVC filter This was shown by Rogers et al where 23 of trauma patients receiving prophylactic filters developed a PE They can also occur as a recurrence ie where a PE has already been demonstrated prior IVC filter insertion in 25 to 77 of patients1 2
Caval thrombosis resulting in occlusion have been reported to occur in between 1-24 of cases depending on the type of filter3 4 Guidewire and catheter entrapment during central venous and pulmonary artery catheter placement have also been reported as long term IVC filters become more prevalent Filter penetration and filter fragmentation have all been described
With the advent of retrievable filters there is renewed popularity for temporary caval interruption To our knowledge no one has yet to follow the population of intended temporary caval interruption who undergo failed retrieval and consequently end up with a permanent IVC filter This study will look at the incidence and degree of caval occlusion caval stenosis and incidence of DVT in patients at The Alfred who have had a failed retrieval of an implanted IVC filter Patient will be recruited for up to four years the incidence of failed retrieval at The Alfred is 10 per year and follow up will be ongoing
Patient Population Alfred patients undergoing temporary IVC filter placement and subsequently have had failed IVC filter retrieval
Study Design This is a prospective single-arm study
Patients identified with failed filter retrieval will be asked to participate in the study They will have a CT cavagram and lower limb duplex doppler ultrasound annually which is part of standard patient management practice
Clinical evaluation history-taking and examination for filter complications and venous hypertension will be conducted annually again as part of standard patient management
Data will be collected as per data collection forms and analysed
Enrolment Size 40 patients will be enrolled
Primary End-Points CT cavagram will be used to evaluatemeasure
Caval occlusion
Caval stenosis
Chronic or acute DVT will be evaluated with
Duplex sonography
Secondary End-points Adverse events related to IVC filter as established through
Physical examination
Patient interview
Research Plan
Specific Aim
To evaluate the long term outcomes for failed IVC retrieval
Objectives
To determine the risk of IVC stenosis due to failed filter retrieval
To determine the risk of IVC occlusion due to failed filter retrieval
To identify the risk of DVT due to failed filter retrieval
To analyse the clinical outcomes symptoms their prevalence and their distribution produced as a result of failed filter retrieval
Research Design and Methods
This is a prospective single-arm clinical study An will be made to the HREC to obtain ethics approval for this study Participants will be enrolled consecutively
Patients will receive routine care and their data will be analysed annually as collected The follow-up period is indefinite and will be at the discretion of the treating doctor
The data from the CT cavagram and duplex Doppler will be collected by the research assistant from the patients histories and reported onto the Investigations data sheet see Appendix I
The data from the clinical interview and examination will be collected from the patients histories and reported onto the Examination data sheet see Appendix II
Analysis Plan and Statistical Methods
This study will look at the incidence and degree of caval occlusion caval stenosis and incidence of DVT in patients at The Alfred who have had a failed retrieval of an implanted IVC filter
Data management quality control Non-identifiable information will be collected and securely stored in the Radiology Department research office Data will be entered into an excel spreadsheet and the incidence of the primary and secondary endpoints summarised
Complications and Reporting of Adverse Events
There are no direct medical complications that might arise due to participation in this trial as patients will have routine care This study involves data collection and no change to routine management Any adverse event in reporting identifiable data will be reported to the HREC committee within 24 hours from the identification of the event
Complications resulting from the CT cavagram include
Contrast Allergy
Anaphylaxis
Infection
Adverse events therefore relate principally to confidentiality See Data Management below for procedures related to adverse event reporting for breach of confidentiality
Data Management
Data will be collated stored and analysed by the research coordinator Dr Helen Kavnoudias
All data forms will be de-identified prior to reporting andor publication of results
Patient medical records will be appropriately labelled as participants of research study and kept indefinitely
All departmental procedures relating to research ethics and privacy regulations will be adhered to
Adverse events involving data management will be reported to the ethics committee with 24-hours by the research team
Time-frame
This research will be ongoing There are approximately 10 failed retrievals each year
References
1 Wolf F Thurnher S Lammer J Simon nitinol vena cava filters Effectiveness and complications Rofo Fortschr Geb Rontgenstr Neuen Bildgeb Verfahr 2001 173 924-30
2 Harries SR Wells IP Roobottom VA Long term follow up of the antheor interior vena cava filter Clin Radiol 1998 53 350-2
3 Millward SF Peterson RA Moher D et al LGM Vena Tech vena caval filter Experience at a single institution J Vase Interv Radiol 1994 5351-6
4 Greenfield LJ Proctor MC Cho KJ et al Extended evaluations of the titanium Greenfield vena caval filter J Vasc Surg 1996 20 458-65
Appendix I
Investigations
Date Follow-Up
Name
Sex
Age
UR
CT Cavagram Is there occlusion of the IVC Yes No Is there 50 stenosis of the IVC Yes No
Is there 20 stenosis of the IVC Yes No
Duplex Doppler Is there presence of thrombus Yes No
If yes where
Is the thrombus Acute Chronic
Appendix II
Examination
Date Follow-Up
Name
Sex
Age
UR
Does the patient suffer from any of the following
please tick ٱLower limb venous incompetence ٱ Chronic limb pain ٱ Oedema ٱ Discolouration ٱ Ulceration ٱ Historical episodes of DVT ٱ PE ٱ Filter-fragmentation embolisation
CEAP Score
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None