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

Phase 2

Terminated

• Conditions: Deep Vein Thrombosis
• Interventions: Drug: microplasmin

• Registration Number: NCT00428129
• Lead Sponsor: ThromboGenics

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-01-26
• Study First Submitted QC: 2007-01-26
• Study First Posted: 2007-01-29
• Study Start: 2007-03
• Primary Completion: 2008-07
• Study Completion: 2008-10
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-04
• Last Update Posted: 2014-04-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	microplasmin	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Section of Interventional Radiology, Department of Radiology, University College Hospital, Newcastle Road; 🇮🇪 Galway, Co Galway, Ireland