Status:
TERMINATED
Microplasmin Administered Via the Trellis-8 Infusion System for Treatment of Acute Iliofemoral DVT
Lead Sponsor:
ThromboGenics
Collaborating Sponsors:
Bacchus Vascular
Conditions:
Deep Vein Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00428129
Start Date
March 1 2007
End Date
October 1 2008
Last Update
April 7 2014
Active Locations (1)
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1
Section of Interventional Radiology, Department of Radiology, University College Hospital, Newcastle Road
Galway, Co Galway, Ireland