Neurovascular Research and Clinical Trials


Clinical Trialsvascular


A Randomized Trial of Unruptured Brain AVMs (ARUBA)

The purpose of this study is to determine if medical management is better than invasive therapy for improving the long-term outcome of patients with unruptured brain arteriovenous malformations. Brain arteriovenous malformations (BAVMs) are an infrequent but important cause of stroke, particularly in a young population. Current invasive treatment strategies are varied and include endovascular procedures, neurosurgery, and radiotherapy. All of these treatments are administered on the assumption that they can be achieved at acceptably minor complication rates, decrease the risk of subsequent hemorrhage, and lead to better long-term outcomes.

Principal Investigator: Mark R. Harrigan, MD
ClinicalTrials.gov Identifier: NCT00389181
Procedure: invasive therapy [endovascular procedures, neurosurgery, or radiotherapy, alone or in combination] Phase III


Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR III)

The overall objective of this Phase III clinical trial is to obtain information from a population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of current clinical practice and national demographics of ICH regarding the benefit (or lack thereof) of IVH clot removal on subject function as measured by Modified Rankin Scale (MRS). This application requests funding for five years to initiate a Phase III randomized clinical trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage. The investigators propose to compare extraventricular drainage (EVD) use, plus recombinant tissue plasminogen activator (rt-PA, Cathflo® Activase® Genentech, Inc., San Francisco, CA) with EVD+ placebo in the management and treatment of subjects with small intracerebral hemorrhage (ICH) and large intraventricular hemorrhage (IVH defined as ICH < 30 cc and obstruction of the 3rd or 4th ventricles by intraventricular blood clot).

Principal Investigator: Mark R. Harrigan, MD
ClinicalTrials.gov Identifier: NCT00784134
Procedure: invasive therapy [endovascular procedures, neurosurgery, or radiotherapy, alone or in combination]

All interventional procedures are standard of care for the treatment of AVMs. They are not experimental.


Personnel

Mark R. Harrigan, MD

Winfield S. Fisher, III, MD


Publications

Argo JL, Yellumahanthi DK, Ballem N, Harrigan MR, Fisher WS 3rd, Wesley MM, Taylor TH, Clements RH. Laparoscopic versus open approach for implantation of the peritoneal catheter during ventriculoperitoneal shunt placement. Surg Endosc. 2009 Jul;23(7):1449-55. Epub 2008 Dec 13.PMID: 19083058

Connors JJ 3rd, Sacks D, Furlan AJ, Selman WR, Russell EJ, Steig PE, Hadley MN: Neurovascular Coalition Writing Group. Training, competency and credentialing standards for diagnostic cervicocerebral angiography, carotid stenting, and cerebrovascular intervention: A joint statement from the American Academy of Neurology, the American Association of Neurological Surgeons, the American Society of Interventional and Therapeutic Neuroradiology, the American Society of Neuroradiology, the Congress of Neurological Surgeons, the AANS/CNS Cerebrovascular Section, and the Society of Interventional Radiology. J Vasc Interv Radiol, 2009. Jul:20(7 Suppl):S292-301.

Zhao L, Rubiera M, Harrigan MR, Alexandrov AV. Arterial ReOcclusion and Persistent Distal Occlusion after Thrombus Aspiration. J Neuroimaging. 2010 Jun 21. [Epub ahead of print] PMID: 20572904

Harrigan MR. Hypertension may be the most important component of hyperdynamic therapy in cerebral vasospasm. Crit Care. 2010 May 14;14(3):151. [Epub ahead of print] PMID: 20497601

Rubiera M, Cava L, Tsivgoulis G, Patterson DE, Zhao L, Zhang Y, Anderson AM, Robinson A, Harrigan MR, Underwood E, Horton J, Alexandrov AV. Diagnostic criteria and yield of real-time transcranial Doppler monitoring of intra-arterial reperfusion procedures. Stroke. 2010 Apr;41(4):695-9. Epub 2010 Feb 18.PMID: 20167923

Fusco MR, Harrigan MR. Cerebrovascular Dissections: A Review, Part I. Spontaneous Dissections. Neurosurgery, 2010, submitted and approved, pending publication.

Fusco MR, Harrigan MR. Cerebrovascular Dissections: A Review, Part II. Blunt Cerebrovascular Injury. Neurosurgery, 2010, submitted and approved, pending publication.

D'Agostino SJ, Harrigan MR, Chalela JA, Nicholas JS, Deveikis SI, Jones TM, Deveikis JP. Clinical experience with Matrix2 360 degrees coils in the treatment of 100 intracranial aneurysms. .Surg Neurol. 2009 Jul;72(1):41-7.PMID: 19559926

Ferrell AS, Tubbs RS, Acakpo-Satchivi L, Deveikis JP, Harrigan MR. Legacy and current understanding of the often-misunderstood Foix-Alajouanine syndrome. Historical vignette. J Neurosurg. 2009 Nov;111(5):902-6.PMID: 19344217

Argo JL, Yellumahanthi DK, Ballem N, Harrigan MR, Fisher WS 3rd, Wesley MM, Taylor TH, Clements RH. Laparoscopic versus open approach for implantation of the peritoneal catheter during ventriculoperitoneal shunt placement. Surg Endosc. 2009 Jul;23(7):1449-55. Epub 2008 Dec 13.PMID: 19083058

Harrigan MR, Rajneesh KF, Ardelt AA, Fisher WS. Short term antifibrinolytic therapy prior to early aneurysm treatment in subarachnoid hemorrhage: Effects on rehemorrhage, cerebral ischemia, and hydrocephalus. Submitted, Neurosurgery, 2009

Menendez JY and Harrigan MR. X-Configuration stent-assisted coiling: Case illustration. Submitted, Neuroradiology, 2009

Zhao L, Rubiera M, Harrigan MR, Alexandrov AV. Arterial re-occlusion and persistent distal occlusion in a stroke patient after thrombus aspiration. In preparation, 2010

Van Gompel JJ, Griessenauer CJ, Scheithauer B, Amrami KK, Spinner RJ. Vascular malformations as a rare cause of sciatica – a case series. Neurosurgery 2010, accepted for publication.

Fleming JB, Shannon CN, Hoh, B; Fargen KM, Mericle RA; Simon SD; Pride GL; Purdy PD; Welch BG; Harrigan MR. Rebleeding Risk after Treatment of Ruptured Intracranial Aneurysms. Submitted, awaiting publication

Naftel RN, Tubbs RS, Reed GT, Wellons JC. Small Ventricular Access Prior to Rigid Neuroendoscopy: Technical note. Journal of Neurosurgery-Pediatrics. (In Publication)

Fusco MR, Harrigan MR. Cerebrovascular Dissections: A Review, Part I. Spontaneous Dissections. Neurosurgery, 2010, submitted and approved, pending publication.

Fusco MR, Harrigan MR. Cerebrovascular Dissections: A Review, Part II. Blunt Cerebrovascular Injury. Neurosurgery, 2010, submitted and approved, pending publication.