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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-10-31

Brief Summary

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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

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Detailed Description

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Conditions

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Deep Vein Thrombosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

microplasmin

Intervention Type DRUG

20mg with Trellis-8 15cm Treatment length 40mg with Trellis-8 30cm Treatment length

Interventions

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microplasmin

20mg with Trellis-8 15cm Treatment length 40mg with Trellis-8 30cm Treatment length

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with radiographically-confirmed acute proximal DVT

Exclusion Criteria

* 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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No