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

NCT00428129 | Terminated Phase 2 DMC

• 1 other identifier: TG-M-005
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Conditions

Deep Vein Thrombosis

Keywords

Acute Iliofemoral Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

• Treatment success - treated segment has < 25% residual thrombus AND flow is present following administration of microplasmin

  During intervention procedure

Secondary Outcomes (4)

• 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

Study Arms (1)

1

EXPERIMENTAL

Drug: microplasmin

Interventions

microplasmin DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with radiographically-confirmed acute proximal DVT

You may not qualify if:

• 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).

Sponsors & Collaborators

• ThromboGenics: lead
• Bacchus Vascular: collaborator

Study Sites (1)

Section of Interventional Radiology, Department of Radiology, University College Hospital, Newcastle Road

Galway, Co Galway, Ireland

Location

MeSH Terms

Conditions

Venous Thrombosis

Interventions

microplasmin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gerard O'Sullivan, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2007
• First Posted: January 29, 2007
• Study Start: March 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: October 1, 2008
• Last Updated: April 7, 2014

Record last verified: 2014-04

Locations

IE (1)