Title
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
Phase
Phase 2Lead Sponsor
Oxurion NV.Study Type
InterventionalStatus
TerminatedIndication/Condition
Deep Vein ThrombosisIntervention/Treatment
ocriplasmin ...Study Participants
6A 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
20mg with Trellis-8 15cm Treatment length 40mg with Trellis-8 30cm Treatment length
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).