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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014