Superselective Administration of VErapamil During Recanalization in Acute Ischemic Stroke

• Status: Completed
• Trial end date: 2016-03-21
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether super-selective intra-arterial administration of verapamil immediately following successful intra-arterial thrombolysis is safe as a potential neuroprotective agent. Standard procedures are cerebral angiography and intra-arterial thrombolysis (intra-arterial administration of tPA and/or mechanical thrombectomy). Experimental procedure is superselective injection of verapamil intra-arterially.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Justin Fraser; University of Kentucky
• Treatments: Verapamil

Criteria

Inclusion Criteria:

1. Patients 21-85 years old, male or female

2. Suspected acute ischemic stroke based on clinical and radiographic evidence as determined and documented by the Stroke Neurology team at University of Kentucky.

3. Patients must meet criteria for intra-arterial thrombolysis as determined and documented by Interventional Neuroradiology attending physician (JF or AA).

4. Patients must have an acute thromboembolus within an intracranial artery (internal carotid, anterior cerebral, middle cerebral, posterior cerebral, basilar, vertebral) which undergoes pharmacologic (tissue plasminogen activator - tPA) and/or mechanical (eg. Merci or Penumbra clot retrieval) thrombolysis.

5. Patients with impaired capacity may be included, as the pathology to be studied (stroke) may impair their capacity (please see attached required documentation regarding impaired capacity).

6. Patients must have a TICI 2A or better revascularization via intra-arterial thrombolysis.

For reference, the TICI Scale is defined below:

0 = No Perfusion

1. = Perfusion past the initial obstruction but limited distal branch filling with little or slow distal perfusion

2. A = Perfusion of less than 50% of the vascular distribution of the occluded artery

2B = Perfusion of 50% or greater (but not complete) of the vascular distribution of the occluded artery 3 = Full perfusion with filling of all distal branches

Exclusion Criteria:

1. Pregnant women (would not qualify for intra-arterial thrombolysis as standard of care).

2. Patients who undergo intra-arterial thrombolysis for acute stroke, in whom only TICI 0 or 1 revascularization is obtained.

3. Patients with occlusion of the cervical common or internal carotid artery will be excluded from the study.