Status:
COMPLETED
Superselective Administration of VErapamil During Recanalization in Acute Ischemic Stroke
Lead Sponsor:
Justin Fraser
Conditions:
Ischemic Stroke
Eligibility:
All Genders
21-85 years
Phase:
PHASE1
Brief 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 neuropr...
Detailed Description
This trial represents the first time that verapamil will be evaluated in human subjects as a superselectively administered neuroprotective agent administered in an acute time frame as an adjunct to in...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2016
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT02235558
Start Date
February 1 2013
End Date
March 21 2016
Last Update
January 23 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Kentucky Deparment of Neurosurgery, UK Chandler Hospital
Lexington, Kentucky, United States, 40536