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

Deep Vein Thrombosis Clinical Trial

— MAX-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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00428129
• Other study ID #: TG-M-005
• Status: Terminated
• Phase: Phase 2
• First received: January 26, 2007
• Last updated: April 4, 2014
• Start date: March 2007
• Est. completion date: October 2008

Study information

• Verified date: April 2014
• Source: ThromboGenics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Irish Medicines Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: October 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• microplasmin
20mg with Trellis-8 15cm Treatment length 40mg with Trellis-8 30cm Treatment length

Locations

Country	Name	City	State
Ireland	Section of Interventional Radiology, Department of Radiology, University College Hospital, Newcastle Road	Galway	Co Galway

Sponsors (2)

Lead Sponsor	Collaborator
ThromboGenics	Bacchus Vascular

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment success - treated segment has < 25% residual thrombus AND flow is present following administration of microplasmin		During intervention procedure	No
Secondary	Grade of lysis		Upon completion of procedure	No
Secondary	Limb patency		Baseline, 48h post procedure, Day-7 and Day-30	No
Secondary	Target limb reintervention		Day-7 and Day-30	No
Secondary	Clinical outcomes		Baseline, 48h post procedure, Day-7 and Day-30	No