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

Study Overview
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Brief Summary
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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

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

Conditions
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Deep Vein Thrombosis

Intervention / Treatment
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* Drug: microplasmin


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: microplasmin<br>* 20mg with Trellis-8 15cm Treatment length 40mg with Trellis-8 30cm Treatment length<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment success - treated segment has < 25% residual thrombus AND flow is present following administration of microplasmin |  | During intervention procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Iliofemoral Deep Vein Thrombosis