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

An Open Label Clinical Trial of Microplasmin Administered Via the Trellis-8 Infusion System for the Treatment of Acute Iliofemoral Deep Vein Thrombosis

A single centre, single-arm study to evaluate safety and efficacy of microplasmin administration via the Trellis-8 Infusion System in patients with acute iliofemoral DVT

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).