Microplasmin Administered Via the Trellis-8 Infusion System for Treatment of Acute Iliofemoral DVT (NCT00428129) | Clinical Trial Compass
TerminatedPhase 2
Microplasmin Administered Via the Trellis-8 Infusion System for Treatment of Acute Iliofemoral DVT
Stopped: Sponsor's decision to not pursue uPLi for vascular conditions including DVT.
Ireland6 participantsStarted 2007-03
Plain-language 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
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 insuff…
What they're measuring
1
Treatment success - treated segment has < 25% residual thrombus AND flow is present following administration of microplasmin