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

Primary Purpose

Deep Vein Thrombosis

Status

Terminated

Phase

Phase 2

Locations

Ireland

Study Type

Interventional

Intervention

microplasmin

About this trial

This is an interventional treatment trial for Deep Vein Thrombosis focused on measuring Acute Iliofemoral Deep Vein Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Grade of lysis

Limb patency

Target limb reintervention

Clinical outcomes

Full Information

NCT ID

NCT00428129

First Posted

January 26, 2007

Last Updated

April 4, 2014

Sponsor

ThromboGenics

Collaborators

Bacchus Vascular

1. Study Identification

Unique Protocol Identification Number

NCT00428129

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Terminated

Why Stopped

Sponsor's decision to not pursue uPLi for vascular conditions including DVT.

Study Start Date

March 2007 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ThromboGenics

Collaborators

Bacchus Vascular

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Deep Vein Thrombosis

Keywords

Acute Iliofemoral Deep Vein Thrombosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

microplasmin

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

During intervention procedure

Secondary Outcome Measure Information:

Title

Grade of lysis

Time Frame

Upon completion of procedure

Title

Limb patency

Time Frame

Baseline, 48h post procedure, Day-7 and Day-30

Title

Target limb reintervention

Time Frame

Day-7 and Day-30

Title

Clinical outcomes

Time Frame

Baseline, 48h post procedure, Day-7 and Day-30

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerard O'Sullivan, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Galway

State/Province

Co Galway

Country

Ireland

12. IPD Sharing Statement

Learn more about this trial

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

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