Clinical trial NCT02066597: Single Session Percutaneous Mechanical Thrombectomy for the Treatment of Ilio-femoral Deep Vein Thrombosis: A Preliminary Evaluation
Official title: Single Session Percutaneous Mechanical Thrombectomy for the Treatment of Ilio-femoral Deep Vein Thrombosis: A Preliminary Evaluation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Deep Vein Thrombosis
Venous Thromboembolism
Keywords: Deep vein thrombosis
thrombectomy
percutaneuos
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2014-02-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 1. objectively diagnosed IFDVT
2. symptom duration \< 14 days for the DVT episode in the index leg at the time of enrolment
3. age \> 18 years

Exclusion criteria:

1. indications for thrombolytic therapy (i.e. phlegmasia cerulean dolens)
2. pregnancy
3. life expectancy \< 6 months
4. severe kidney disease (creatinine clearance \< 30 mL min)
5. refusal to provide informed consent or inability to follow up
6. allergy to contrast media
7. the lesion cannot be accessed with the wire guide
8. prior history of ipsilateral DVT or femoral catheters

Primary outcomes:
measure: angiographic luminal patency
timeFrame: 1 day
Secondary outcomes:
measure: Recurrent VTE
timeFrame: 3 months
measure: Patency
timeFrame: Seven days and 3 months
measure: Bleeding
timeFrame: 3 months
measure: PTS using Villalta score
timeFrame: 3 months
measure: Hemolyisis
timeFrame: 7 days
measure: Quality of Life
timeFrame: 3 months
measure: Procedure associated complications
timeFrame: 3 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
Study officials:
affiliation: OHRI
name: Esteban Gandara, MD
role: PRINCIPAL_INVESTIGATOR
References: