Pulmonary EmbolismNCT00654979
A Pivotal Study to Evaluate the Safety and Effectiveness of RMT Medical Technology's SafeFlo® Vena Cava Filter
A study testing SafeFlo IVC Filter in people with Pulmonary Embolism, run by RMT Medical Technologies, Ltd. at 8 sites in 6 countries.
Trial summary
To determine the safety and effectiveness of the SafeFlo filter for permanent protection against pulmonary emboli. All patients will be selected to receive the filter according to the stated inclusion / exclusion criteria after consultation between the attending physician and interventional radiologist. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- SafeFlo IVC Filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 8 sitesin 6 countries
- Study dates
- Jul 2003to Mar 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Traditional indications for vena cava filter in patients with established DVT or PE, including (40):
- Patients with proven Pulmonary Embolus (PE) or Deep Vein Thrombosis (DVT) and one or more of the following:
- Contraindication to anticoagulation
- Complication of anticoagulation
- Failure of anticoagulation
- Recurrent PE despite adequate anticoagulation therapy
Show all 19Show fewer
- Inability to achieve adequate anticoagulation
- Poor compliance with anticoagulation medications
- Extended indications for vena cava filter placement in patients with established DVT or PE, including the following (31, 40):
- Large free-floating thrombus in the iliac vein or IVC;
- Following massive PE in which recurrent emboli may prove fatal;
- During/after surgical or transcatheter embolectomy;
- Filter placement in high-risk trauma and orthopedic patients:
- High risk trauma or orthopedic patients who cannot receive anticoagulation because of increased bleeding risk, and have one or more of the following injury patterns (31, 40):
- Severe closed head injury (GCS < 8);
- Incomplete spinal cord injury with para or quadriplegia;
- Complex pelvic fractures with associated long-bone fractures;
- Multiple long bone fractures.
- Patients undergoing long-term immobilization (e.g., ICU or Surgical oncology)
Who cannot join
- All patients under 18 years of age.
- All patients undergoing emergency procedures.
- All patients with abnormal IVC anatomy or pathology of the IVC such as thrombosis or tumor which prevent safe filter implantation.
- All patients with an IVC diameter which precludes oversizing of the filter platform.
- All patients with active infection / bacteremia.
- All patients with sensitivity to contrast media.
- Uncorrectable severe coagulopathy (e.g., patients with liver or multisystem failure).
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
United States3 sites
Mt. Sinai Hospital
Manhattan, New York
Holy Name Hospital
Teaneck, New Jersey
Montefiore Medical Center
The Bronx, New York
About this study
To determine the safety and effectiveness of the SafeFlo filter for permanent protection against pulmonary emboli. All patients will be selected to receive the filter according to the stated inclusion / exclusion criteria after consultation between the attending physician and interventional radiologist. Patients with a permanent implantation will be followed for up to 6 months. Clinical success will be defined as no occurrences of any of the following events: recurrent pulmonary embolism, IVC occlusion or filter embolization. The proportion of permanent filter patients considered to be a clinical success will be the primary efficacy parameter.
- Conditions
- Pulmonary Embolism
- Being tested
- SafeFlo IVC Filter
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SafeFlo IVC FilterDevice
SafeFlo IVC Filter
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | SafeFlo IVC Filter Receives: Device: SafeFlo IVC Filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success will be defined as no occurrences of any of the following events: recurrent pulmonary embolism, IVC occlusion or filter embolization.
Measured: 6 months follow-up
Secondary outcomes (1)
The proportion of patients with successful deployment of the filter will be calculated and presented with a 95% exact confidence interval.
Measured: 3 and 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2008 (estimated)
- Study startJul 2003
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- RMT Medical Technologies, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacob Cynamon, Dr., Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00654979
- Sponsor's protocol ID
- SFF-104
- Status last verified
- May 2013
- First submitted
- 30 Mar 2008
- Last updated
- 31 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Study to Evaluate the Safety and Effectiveness of RMT Medical Technology's SafeFlo® Vena Cava Filter
- ClinicalTrials.gov ID
- NCT00654979
- Acronym / sponsor ID
- SFF-104
- Conditions
- Pulmonary Embolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- RMT Medical Technologies, Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 9 Apr 2008 (estimated)
- 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.
To determine the safety and effectiveness of the SafeFlo filter for permanent protection against pulmonary emboli. All patients will be selected to receive the filter according to the stated inclusion / exclusion criteria after consultation between the attending physician and interventional radiologist. Patients with a permanent implantation will be followed for up to 6 months. Clinical success will be defined as no occurrences of any of the following events: recurrent pulmonary embolism, IVC occlusion or filter embolization. The proportion of permanent filter patients considered to be a clinical success will be the primary efficacy parameter.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: SafeFlo IVC FilterSafeFlo IVC Filter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Traditional indications for vena cava filter in patients with established DVT or PE, including (40):
- Extended indications for vena cava filter placement in patients with established DVT or PE, including the following (31, 40):
- High risk trauma or orthopedic patients who cannot receive anticoagulation because of increased bleeding risk, and have one or more of the following injury patterns (31, 40):
- Patients undergoing long-term immobilization (e.g., ICU or Surgical oncology)
Key exclusion criteria (7 listed)
- All patients under 18 years of age.
- All patients undergoing emergency procedures.
- All patients with abnormal IVC anatomy or pathology of the IVC such as thrombosis or tumor which prevent safe filter implantation.
- All patients with an IVC diameter which precludes oversizing of the filter platform.
- All patients with active infection / bacteremia.
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 |
|---|---|---|
| SafeFlo IVC FilterSafeFlo IVC Filter | Device | Single arm |
Primary outcome
Clinical success will be defined as no occurrences of any of the following events: recurrent pulmonary embolism, IVC occlusion or filter embolization.
Time frame: 6 months follow-up
1 secondary outcome
The proportion of patients with successful deployment of the filter will be calculated and presented with a 95% exact confidence interval.
Time frame: 3 and 6 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2013.
- Sponsor WebsiteLink provided by the sponsor.
Related trials for Pulmonary Embolism
RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Inari VISION Registry
Pulmonary Embolism
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
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.
Jacob Cynamon, Dr. principal investigator
Montefiore Medical Center
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SafeFlo IVC Filter in people with Pulmonary Embolism, run by RMT Medical Technologies, Ltd. at 8 sites in 6 countries.
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 19 inclusion and 7 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: finished, as of the sponsor's last update on 31 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Austria, Greece, Israel, South Africa and 1 more country. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success will be defined as no occurrences of any of the following events: recurrent pulmonary embolism, IVC occlusion or filter embolization. (time frame: 6 months follow-up). 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 31 May 2013.