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

An Open Label Clinical Trial of Microplasmin Administered Via the Trellis-8 Infusion System for the Treatment of Acute Iliofemoral Deep Vein Thrombosis

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 Overview

• Status: Terminated
• Conditions: Deep Vein Thrombosis
• Intervention / Treatment: Drug: microplasmin

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• Ireland
  • Co Galway
    • Galway, Co Galway, Ireland
      • Section of Interventional Radiology, Department of Radiology, University College Hospital, Newcastle Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1	Drug: microplasmin; 20mg with Trellis-8 15cm Treatment length 40mg with Trellis-8 30cm Treatment length

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Treatment success - treated segment has < 25% residual thrombus AND flow is present following administration of microplasmin	During intervention procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Grade of lysis	Upon completion of procedure
Limb patency	Baseline, 48h post procedure, Day-7 and Day-30
Target limb reintervention	Day-7 and Day-30
Clinical outcomes	Baseline, 48h post procedure, Day-7 and Day-30

Collaborators and Investigators

• Sponsor: ThromboGenics
• Collaborators: Bacchus Vascular
• Investigators: Principal Investigator: Gerard O'Sullivan, MD, Section of Interventional Radiology, Department of Radiology, University College Hospital, Newcastle Road, Galway

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (ACTUAL): July 1, 2008
• Study Completion (ACTUAL): October 1, 2008

Study Registration Dates

• First Submitted: January 26, 2007
• First Submitted That Met QC Criteria: January 26, 2007
• First Posted (ESTIMATE): January 29, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): April 7, 2014
• Last Update Submitted That Met QC Criteria: April 4, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Acute Iliofemoral Deep Vein Thrombosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Plasminogen
• Other Study ID Numbers: TG-M-005