Clinical trial NCT00428129: Microplasmin Administered Via the Trellis-8 Infusion System for Treatment of Acute Iliofemoral DVT
Official title: An Open Label Clinical Trial of Microplasmin Administered Via the Trellis-8 Infusion System for the Treatment of Acute Iliofemoral Deep Vein Thrombosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Deep Vein Thrombosis
Keywords: Acute Iliofemoral Deep Vein Thrombosis
Lead sponsor: ThromboGenics
Sponsor class: INDUSTRY
Collaborators: name: Bacchus Vascular
First posted: 2007-01-29
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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).

Primary outcomes:
measure: Treatment success - treated segment has < 25% residual thrombus AND flow is present following administration of microplasmin
timeFrame: During intervention procedure
Secondary outcomes:
measure: Grade of lysis
timeFrame: Upon completion of procedure
measure: Limb patency
timeFrame: Baseline, 48h post procedure, Day-7 and Day-30
measure: Target limb reintervention
timeFrame: Day-7 and Day-30
measure: Clinical outcomes
timeFrame: Baseline, 48h post procedure, Day-7 and Day-30
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: Section of Interventional Radiology, Department of Radiology, University College Hospital, Newcastle Road
state: Co Galway
Study officials:
affiliation: Section of Interventional Radiology, Department of Radiology, University College Hospital, Newcastle Road, Galway
name: Gerard O'Sullivan, MD
role: PRINCIPAL_INVESTIGATOR
References: