Microplasmin Administered Via the Trellis-8 Infusion System for Treatment of Acute Iliofemoral DVT

• microplasmin (Drug): 20mg with Trellis-8 15cm Treatment length 40mg with Trellis-8 30cm Treatment length

Primary outcomes

• Treatment success - treated segment has < 25% residual thrombus AND flow is present following administration of microplasmin [During intervention procedure]

Secondary outcomes

• Grade of lysis [Upon completion of procedure]
• Limb patency [Baseline, 48h post procedure, Day-7 and Day-30]
• Target limb reintervention [Day-7 and Day-30]
• Clinical outcomes [Baseline, 48h post procedure, Day-7 and Day-30]

Sex: All, ages: 18 Years to any

Inclusion Criteria include:

* Patients with radiographically-confirmed acute proximal DVT

Exclusion Criteria include:

* Isolated calf or popliteal vein DVT, based on duplex ultrasound
* Thrombus involving the inferior vena cava (IVC)
* Proximal (e.g. cranial) aspect of thrombus cannot be adequately assessed to level of the iliac veins or inferior vena cava, based on duplex ultrasound.
* Cannot traverse the target vessel segment with guidewire
* Symptomatic pulmonary embolism is present at time of presentation
* Documented history of prior DVT in target extremity
* History of anticoagulants administered for > 30 days for undocumented/ unclear reason (e.g. for reasons other than presence of mechanical cardiac valve, atrial fibrillation, etc.)
* Documented history of thrombophilic disorder, with diagnosis established via previous objective testing (e.g. familial screening for thrombophilia).
* Cannot receive standard secondary prevention pharmacotherapy \[i.e. heparin or LMWH and vitamin K antagonists (VKA)\] due to contraindications to anticoagulation \[e.g. known bleeding diathesis, thrombocytopenia (platelets < 100,000 mm3), heparin induced thrombocytopenia (HIT), known allergy to heparin or warfarin\]
* Absolute contraindication to thrombolytic therapy
* Previous central nervous system haemorrhage
* Life expectancy less than 1 year, due to other comorbid condition.
* Previous intervention in target limb to address venous thrombus.
* Target limb has chronic venous insufficiency of C4 or greater severity
* Acute or chronic symptomatic musculoskeletal condition in target limb (e.g. trauma, fracture, severe arthritis).
* Documented patent foramen ovale or other right-to-left cardiac shunt.
* Absolute contraindication to contrast media or renal insufficiency (baseline creatinine >2.0 mg/dL).

• Gerard O'Sullivan, MD, Principal investigator, Section of Interventional Radiology, Department of Radiology, University College Hospital, Newcastle Road, Galway