Superselective Administration of VErapamil During Recanalization in Acute Ischemic Stroke

Completed · Phase 1

Conditions studied: Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT02235558

Run by

Justin Fraser

People needed

11

Starts

2013-02-01

Expected to finish

2016-03-21

Last updated by the study team

2017-01-23

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients 21-85 years old, male or female
• Suspected acute ischemic stroke based on clinical and radiographic evidence as determined and documented by the Stroke Neurology team at University of Kentucky.
• Patients must meet criteria for intra-arterial thrombolysis as determined and documented by Interventional Neuroradiology attending physician (JF or AA).
• 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.
• 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).
• Patients must have a TICI 2A or better revascularization via intra-arterial thrombolysis.
• For reference, the TICI Scale is defined below:
• 0 = No Perfusion
• = Perfusion past the initial obstruction but limited distal branch filling with little or slow distal perfusion
• 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

You may not qualify if…

• Pregnant women (would not qualify for intra-arterial thrombolysis as standard of care).
• Patients who undergo intra-arterial thrombolysis for acute stroke, in whom only TICI 0 or 1 revascularization is obtained.
• Patients with occlusion of the cervical common or internal carotid artery will be excluded from the study.

Where it is running

• University of Kentucky Deparment of Neurosurgery, UK Chandler Hospital — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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