Intra-arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion (MITI-IA)

ThromboGenics

Status and phase

Terminated

Phase 2

Conditions

Stroke

Treatments

Drug: Microplasmin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00123266

TG-M-003

Details and patient eligibility

About

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.

Full description

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.

Enrollment

2 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
Rapidly improving neurologic signs at any time before initiation of study drug administration.
Known contrast agent-sensitivity
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.
History of stroke within the previous 6 weeks.