Superselective Administration of VErapamil During Recanalization in Acute Ischemic Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 1

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.
    

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 intra-arterial thrombolysis. The methods for administration, along with the
      routinized followup, will provide a paradigm for studying other potential neuroprotective
      agents. Subjects will undergo cerebral angiography with intra-arterial thrombolysis, which is
      standard of care. 'Intra-arterial thrombolysis will include possible intra-arterial
      administration of tPA, as well as possible mechanical thrombectomy with an accepted
      thrombectomy device. This includes the Mercí Retriever (Concentric Medical, Mountain View,
      CA), the Penumbra System (Penumbra, Alameda, CA), the Solitaire stent-triever (EV3, Covidien,
      Irvine, CA), and the Trevo stent-triever (Concentric Medical, Mountain View, CA). Immediately
      after the intra-arterial thrombolysis component of the angiographic procedure is completed,
      the microcatheter used during the procedure will be left in or guided into the vessel
      location of the clot. 10mg of verapamil in 20cc of normal saline will be administered over 20
      minutes (1cc/minute) through the microcatheter and into the vessel previously obstructed by
      clot. At the conclusion of infusion, the microcatheter will be removed. Angiography through
      the guide catheter of the cerebral circulation in question will be performed to ensure no new
      thromboembolic event from the microcatheterization (standard of care). The catheters will be
      removed, and the arterial puncture site closed in the standard fashion. Patients will receive
      a noncontrast CT scan or MRI approximately 24 hours after intervention to determine the
      presence or absence of intracerebral hemorrhage (ICH) after intervention. This would be
      considered standard practice for intra-arterial thrombolysis. Both imaging studies can detect
      ICH, and the choice of one or the other will be determined by clinical criteria; CT or MRI
      may be preferable for different reasons depending upon the patient's clinical scenario. The
      determination of hemorrhage will be made by the official dictation of a diagnostic
      neuroradiologist not directly involved in the study. The hemorrhage will be considered an
      adverse event if it is deemed symptomatic in accordance with the criteria used in the
      International Management of Stroke (IMS) III study. Briefly, a hemorrhage is defined as
      symptomatic if occurring within 24+/-6 hours after study inclusion, temporally related to the
      intervention, and occurs with worsening neurological status as documented in the clinical
      exam. A 4 point or more increase in the NIHSS stroke scale would qualify as a significant
      worsening in status. Furthermore, hemorrhage that requires intervention surgically or
      endovascularly would be deemed significant.
    

Intervention name(s): Verapamil
Intervention type(s): Drug
Intervention description(s): Super-selective intra-arterial administration of 10mg verapamil in 20cc of normal saline will be administered over 20 minutes (1cc/minute) through the microcatheter and into the vessel previously obstructed by clot, immediately following successful intra-arterial thrombolysis. Half-life is 2.8-7.4 hrs.
Other intervention name(s): Isoptin; Verelan; Verelan PM; Calan; Bosoptin; Calaptin; Covera-HS
Intervention MeSH terms: Verapamil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Ischemic Stoke; Thrombectomy; Intraarterial Pharmacotherapy; Neuroprotection