Deep Vein Thrombosis
Conditions
Keywords
Acute Iliofemoral Deep Vein Thrombosis
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
Interventions
DRUGmicroplasmin
20mg with Trellis-8 15cm Treatment length 40mg with Trellis-8 30cm Treatment length
Sponsors
Bacchus Vascular
ThromboGenics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment success - treated segment has < 25% residual thrombus AND flow is present following administration of microplasmin | During intervention procedure |
Secondary
| Measure | 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 |
Countries
Ireland
Outcome results
None listed