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

• Status: Terminated
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ThromboGenics
• Collaborator: Bacchus Vascular
• Treatments: Plasminogen

Criteria

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).