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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00428129
Recruitment Status : Terminated (Sponsor's decision to not pursue uPLi for vascular conditions including DVT.)
First Posted : January 29, 2007
Last Update Posted : April 7, 2014
Bacchus Vascular
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Drug: microplasmin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Ocriplasmin

Arm Intervention/treatment
Experimental: 1 Drug: microplasmin
20mg with Trellis-8 15cm Treatment length 40mg with Trellis-8 30cm Treatment length

Primary Outcome Measures :
  1. Treatment success - treated segment has < 25% residual thrombus AND flow is present following administration of microplasmin [ Time Frame: During intervention procedure ]

Secondary Outcome Measures :
  1. Grade of lysis [ Time Frame: Upon completion of procedure ]
  2. Limb patency [ Time Frame: Baseline, 48h post procedure, Day-7 and Day-30 ]
  3. Target limb reintervention [ Time Frame: Day-7 and Day-30 ]
  4. Clinical outcomes [ Time Frame: Baseline, 48h post procedure, Day-7 and Day-30 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00428129

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Section of Interventional Radiology, Department of Radiology, University College Hospital, Newcastle Road
Galway, Co Galway, Ireland
Sponsors and Collaborators
Bacchus Vascular
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Principal Investigator: Gerard O'Sullivan, MD Section of Interventional Radiology, Department of Radiology, University College Hospital, Newcastle Road, Galway

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Responsible Party: ThromboGenics Identifier: NCT00428129     History of Changes
Other Study ID Numbers: TG-M-005
First Posted: January 29, 2007    Key Record Dates
Last Update Posted: April 7, 2014
Last Verified: April 2014
Keywords provided by ThromboGenics:
Acute Iliofemoral Deep Vein Thrombosis
Additional relevant MeSH terms:
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Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action