Intra-arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-08-31

Brief Summary

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The purpose of the trial is to evaluate the safety of microplasmin as well as its ability to open blocked arteries to the brain in patients with acute stroke when given into the artery at the site of the blockage.

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Detailed Description

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Patients with angiographically documented acute intracranial vertebrobasilar artery occlusion presenting within 24 hours of neurological symptom onset will be enrolled into this open-label trial. During study drug administration, angiograms will be repeated at regular intervals to determine degree of clot lysis.

Conditions

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Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active

Group Type EXPERIMENTAL

Microplasmin

Intervention Type DRUG

2 mg/kg, IA over 75 mins

Interventions

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Microplasmin

2 mg/kg, IA over 75 mins

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients with angiographically documented vertebrobasilar artery occlusion
2. Initiation of study drug treatment within 24 hours of the onset of neurological symptoms
3. Age 18-75 (inclusive).

Exclusion Criteria

1. Patients with coma \> 6 hrs duration and complete loss of brain stem reflexes (corneal reflex, gag reflex, VOR, pupil reflexes) as measured at the last assessment before sedation/intubation
2. Rapidly improving neurologic signs at any time before initiation of study drug administration.
3. Known contrast agent-sensitivity
4. Uncontrolled hypertension defined as a systolic blood pressure \> 180 mm Hg or a diastolic blood pressure \> 100 mm Hg on 3 separate occasions at least 10 minutes apart or requiring continuous IV therapy.
5. History of stroke within the previous 6 weeks.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No