Deep Vein ThrombosisPhase 2SPADENCT02066597
Single Session Percutaneous Mechanical Thrombectomy for the Treatment of Ilio-femoral Deep Vein Thrombosis: A Preliminary Evaluation
A Phase 2 study testing Thrombectomy in people with Deep Vein Thrombosis and Venous Thromboembolism, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Venous thromboembolism (VTE) is a common condition that occurs when a clot develops in one of your veins. It affects 5% of the population and is the third most common circulatory condition after heart attack and stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis, Venous Thromboembolism
- What is being tested?
- Thrombectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to Dec 2014
- Phase
- Phase 2
- 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
None listed.
Who cannot join
- indications for thrombolytic therapy (i.e. phlegmasia cerulean dolens)
- pregnancy
- life expectancy < 6 months
- severe kidney disease (creatinine clearance < 30 mL min)
- refusal to provide informed consent or inability to follow up
- allergy to contrast media
- the lesion cannot be accessed with the wire guide
- prior history of ipsilateral DVT or femoral catheters
Trial locations and contacts
1 site in 1 country.
About this study
Venous thromboembolism (VTE) is a common condition that occurs when a clot develops in one of your veins. It affects 5% of the population and is the third most common circulatory condition after heart attack and stroke. People who experience a clot in their vein can have significant long term problems with swelling and discomfort. The investigators call this post thrombotic syndrome (PTS). They can also be at increased risk of having another clot occur. People who have ilio-femoral clots are more likely to have more severe leg swelling and pain than those who have clots in smaller veins. They are also more likely to have problems returning to their normal daily routines and may need more hospital visits.
The current standard of care involves treating patients with anticoagulants (blood thinners) because it has a low risk of bleeding risk and is inexpensive. Blood thinners prevent the clot from growing bigger while your own body dissolves the clot over time.
Read more
The type of clot you have is the most severe form of DVT. Some experts advise early removal of the clot - resulting in symptom relief sooner and possibly reducing the risk of PTS. This is in addition to the standard treatment with blood thinners.
There are currently two options for physically removing these clots. One method involves placing an intravenous catheter into your leg and injecting medication directly where the clot is situated. This dissolves the clot. This method is called Catheter Directed Thrombolysis (CDT). The second method, Percutaneous Mechanical Thrombectomy (PMT), involves placing an intravenous catheter into your leg and breaking down the clot mechanically and suctioning it out of the vein - creating good blood flow again to your leg. Both methods require injection of contrast dye and a special x-ray machine to see where the clot is and ensure that the entire clot is removed.
CDT is very expensive and has an increased risk of major bleeding. PMT is much less expensive and has a lower risk of bleeding. The doctors at The Ottawa Hospital do not typically recommend CDT, nor do we commonly perform PMT for this patient population here.
The investigators would like to enroll 26 participants with ilio-femoral DVTs and perform PMT to see if they can achieve better outcomes than for those who have just had our routine treatment of blood thinners. The investigators are only conducting this study here at The Ottawa Hospital, General Campus. They will follow the progress of participants for 6 months. The device the investigators are using (Angiojet Ultra Thrombectomy System) is already approved by Health Canada for this procedure.
- Conditions
- Deep Vein Thrombosis, Venous Thromboembolism
- Being tested
- Thrombectomy
- Keywords
- Deep vein thrombosis, thrombectomy, percutaneuos
- Medical subject headings
- Venous Thrombosis, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThrombectomyDevice
Within 96 hours of enrolment, patients will be treated with a single session of PMT using an AngioJet catheter without adjuvant thrombolysis . Venous access will be obtained at the popliteal vein in all patients with a 5-F sheath through which all subsequent venography procedures will be performed. The AngioJet catheter will then be passed over the guide wire and moved from proximal to distal to remove thrombus. Completion venography will be performed through the sheath in all patients. After the completion of the procedure patients are expected to remain in hospital for no more than six hours (1 hour in post-anaesthesia care unit followed by transfer to the surgical daycare unit from where they will be discharged).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Device: Thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
angiographic luminal patency
The main outcome of the study will be the percentage of patients who achieve an angiographic luminal patency > 50% at the end of the procedure without the need of adjuvant CDT. Luminal patency will be calculated using the thrombus score for seven venous segments. The thrombus score is 0 when the vein was patent and completely free of thrombus, 1 when partially occluded, and 2 when completely occluded. The total thrombus score will be then calculated by adding the scores of the seven venous segments before and after PMT. The difference between the pre- and post-PMT thrombus scores divided by the pre-PMT score will result in the percentage of luminal patency, classified into three groups for analysis: grade I less than 50%, grade II 50%-99%, and grade III for 100%.
Measured: 1 day
Secondary outcomes (7)
Recurrent VTE
Acute symptomatic recurrent DVT or PE
Measured: 3 months
Patency
Patency of the treated segment on ultrasound.
Measured: Seven days and 3 months
Bleeding
Major, clinically relevant and minor peri-procedural bleeding within 7 days and 3 months
Measured: 3 months
PTS using Villalta score
Measured: 3 months
Hemolyisis
Measured: 7 days
Quality of Life
Quality of life at the end of follow up is measured using the VEINES-QOL/Sym score
Measured: 3 months
Procedure associated complications
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startNov 2013
- Primary completionDec 2014
Why it stopped: Recommendation from the DSMB following recurrent DVT in 3/4 participants who underwent the thrombectomy procedure.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esteban Gandara, MD, Principal investigator, OHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066597
- Sponsor's protocol ID
- 20130329-01H
- Acronym
- SPADE
- Status last verified
- Apr 2015
- First submitted
- 5 Nov 2013
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Session Percutaneous Mechanical Thrombectomy for the Treatment of Ilio-femoral Deep Vein Thrombosis: A Preliminary Evaluation
- ClinicalTrials.gov ID
- NCT02066597
- Acronym / sponsor ID
- SPADE / 20130329-01H
- Conditions
- Deep Vein Thrombosis, Venous Thromboembolism
- Keywords
- Deep vein thrombosis, thrombectomy, percutaneuos
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recommendation from the DSMB following recurrent DVT in 3/4 participants who underwent the thrombectomy procedure.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2014 (actual)
- First posted
- 19 Feb 2014 (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.
Venous thromboembolism (VTE) is a common condition that occurs when a clot develops in one of your veins. It affects 5% of the population and is the third most common circulatory condition after heart attack and stroke. People who experience a clot in their vein can have significant long term problems with swelling and discomfort. The investigators call this post thrombotic syndrome (PTS). They can also be at increased risk of having another clot occur. People who have ilio-femoral clots are more likely to have more severe leg swelling and pain than those who have clots in smaller veins. They are also more likely to have problems returning to their normal daily routines and may need more hospital visits.
The current standard of care involves treating patients with anticoagulants (blood thinners) because it has a low risk of bleeding risk and is inexpensive. Blood thinners prevent the clot from growing bigger while your own body dissolves the clot over time.
The type of clot you have is the most severe form of DVT. Some experts advise early removal of the clot - resulting in symptom relief sooner and possibly reducing the risk of PTS. This is in addition to the standard treatment with blood thinners.
There are currently two options for physically removing these clots. One method involves placing an intravenous catheter into your leg and injecting medication directly where the clot is situated. This dissolves the clot. This method is called Catheter Directed Thrombolysis (CDT). The second method, Percutaneous Mechanical Thrombectomy (PMT), involves placing an intravenous catheter into your leg and breaking down the clot mechanically and suctioning it out of the vein - creating good blood flow again to your leg. Both methods require injection of contrast dye and a special x-ray machine to see where the clot is and ensure that the entire clot is removed.
CDT is very expensive and has an increased risk of major bleeding. PMT is much less expensive and has a lower risk of bleeding. The doctors at The Ottawa Hospital do not typically recommend CDT, nor do we commonly perform PMT for this patient population here.
The investigators would like to enroll 26 participants with ilio-femoral DVTs and perform PMT to see if they can achieve better outcomes than for those who have just had our routine treatment of blood thinners. The investigators are only conducting this study here at The Ottawa Hospital, General Campus. They will follow the progress of participants for 6 months. The device the investigators are using (Angiojet Ultra Thrombectomy System) is already approved by Health Canada for this procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Thrombectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- indications for thrombolytic therapy (i.e. phlegmasia cerulean dolens)
- pregnancy
- life expectancy < 6 months
- severe kidney disease (creatinine clearance < 30 mL min)
- refusal to provide informed consent or inability to follow up
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 |
|---|---|---|
| ThrombectomyWithin 96 hours of enrolment, patients will be treated with a single session of PMT using an AngioJet catheter without adjuvant thrombolysis . Venous access will be obtained at the popliteal vein in all patients with a 5-F sheath through which all subsequent venography procedures will be performed. The AngioJet catheter will then be passed over the guide wire and moved from proximal to distal to remove thrombus. Completion venography will be performed through the sheath in all patients. After the completion of the procedure patients are expected to remain in hospital for no more than six hours (1 hour in post-anaesthesia care unit followed by transfer to the surgical daycare unit from where they will be discharged). | Device | Intervention |
Primary outcome
angiographic luminal patency
Time frame: 1 day
The main outcome of the study will be the percentage of patients who achieve an angiographic luminal patency > 50% at the end of the procedure without the need of adjuvant CDT. Luminal patency will be calculated using the thrombus score for seven venous segments. The thrombus score is 0 when the vein was patent and completely free of thrombus, 1 when partially occluded, and 2 when completely occluded. The total thrombus score will be then calculated by adding the scores of the seven venous segments before and after PMT. The difference between the pre- and post-PMT thrombus scores divided by the pre-PMT score will result in the percentage of luminal patency, classified into three groups for analysis: grade I less than 50%, grade II 50%-99%, and grade III for 100%.
7 secondary outcomes
Recurrent VTE
Time frame: 3 months
Patency
Time frame: Seven days and 3 months
Bleeding
Time frame: 3 months
PTS using Villalta score
Time frame: 3 months
Hemolyisis
Time frame: 7 days
Quality of Life
Time frame: 3 months
Procedure associated complications
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Recommendation from the DSMB following recurrent DVT in 3/4 participants who underwent the thrombectomy procedure.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2015.
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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.
Esteban Gandara, MD principal investigator
OHRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thrombectomy in people with Deep Vein Thrombosis and Venous Thromboembolism, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 0 inclusion and 8 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: stopped early, as of the sponsor's last update on 17 Apr 2015. 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recommendation from the DSMB following recurrent DVT in 3/4 participants who underwent the thrombectomy procedure.). Results are not available in the source record.
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?
angiographic luminal patency (time frame: 1 day). 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 Apr 2015.