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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
20mg with Trellis-8 15cm Treatment length 40mg with Trellis-8 30cm Treatment length
Section of Interventional Radiology, Department of Radiology, University College Hospital, Newcastle Road
Galway, Co Galway, Ireland
Treatment success - treated segment has < 25% residual thrombus AND flow is present following administration of microplasmin
Time frame: During intervention procedure
Grade of lysis
Time frame: Upon completion of procedure
Limb patency
Time frame: Baseline, 48h post procedure, Day-7 and Day-30
Target limb reintervention
Time frame: Day-7 and Day-30
Clinical outcomes
Time frame: Baseline, 48h post procedure, Day-7 and Day-30
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