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

This study has been terminated.
(Sponsor's decision to not pursue uPLi for vascular conditions including DVT.)
Sponsor:
Collaborator:
Bacchus Vascular
Information provided by (Responsible Party):
ThromboGenics
ClinicalTrials.gov Identifier:
NCT00428129
First received: January 26, 2007
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Deep Vein Thrombosis
Drug: microplasmin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by ThromboGenics:

Primary Outcome Measures:
  • Treatment success - treated segment has < 25% residual thrombus AND flow is present following administration of microplasmin [ Time Frame: During intervention procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Grade of lysis [ Time Frame: Upon completion of procedure ] [ Designated as safety issue: No ]
  • Limb patency [ Time Frame: Baseline, 48h post procedure, Day-7 and Day-30 ] [ Designated as safety issue: No ]
  • Target limb reintervention [ Time Frame: Day-7 and Day-30 ] [ Designated as safety issue: No ]
  • Clinical outcomes [ Time Frame: Baseline, 48h post procedure, Day-7 and Day-30 ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: March 2007
Study Completion Date: October 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: microplasmin
20mg with Trellis-8 15cm Treatment length 40mg with Trellis-8 30cm Treatment length

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00428129

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

No publications provided

Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT00428129     History of Changes
Other Study ID Numbers: TG-M-005
Study First Received: January 26, 2007
Last Updated: April 4, 2014
Health Authority: Ireland: Irish Medicines Board

Keywords provided by ThromboGenics:
Acute Iliofemoral Deep Vein Thrombosis

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014