Microplasmin Administered Via the Trellis-8 Infusion Syst... | NCT00428129

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

NCT00428129

Sponsor

ThromboGenics

Status

Terminated

Last Update Posted

Apr 7, 2014Estimated

Enrollment

6Actual

Phase

Phase 2

Conditions

Deep Vein Thrombosis

Interventions

microplasmin

Countries

Ireland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

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

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Jul 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Jan 26, 2007

First Submission Date that Met QC Criteria

Jan 26, 2007

First Posted Date

Jan 29, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2014

Last Update Posted Date

Apr 7, 2014Estimated

Name	Class
Bacchus Vascular	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Label	Type	Description	Intervention Names
1	Experimental		Drug: microplasmin

Name	Type	Description	Arm Group Labels	Other Names
microplasmin	Drug	20mg with Trellis-8 15cm Treatment length 40mg with Trellis-8 30cm Treatment length	1

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

Measure	Description	Time Frame
Grade of lysis		Upon completion of procedure
Limb patency		Baseline, 48h post procedure, Day-7 and Day-30
Target limb reintervention

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gerard O'Sullivan, MD	Section of Interventional Radiology, Department of Radiology, University College Hospital, Newcastle Road, Galway	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Section of Interventional Radiology, Department of Radiology, University College Hospital, Newcastle Road		Galway	Co Galway		Ireland

ID	Term
D013927	Thrombosis
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases