Carotid Occlusion Surgery Study

NCT00029146 | Terminated Phase 3 Results DMC

• 2 other identifiers: R01NS042167R01NS041895
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if extracranial-intracranial bypass surgery when added to best medical therapy can reduce the subsequent risk of ipsilateral stroke in high-risk patients with recently symptomatic carotid occlusion and increased cerebral oxygen extraction fraction measured by positron emission tomography (PET).

Conditions

Stroke; Ischemic Attack, Transient; Cerebral Infarction

Keywords

stroke; transient ischemic attack (TIA); carotid arteries; cerebral infarction

Outcome Measures

Primary Outcomes (1)

• Surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-surgery; Non-surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-randomization

  2 yr Kaplan-Meier estimates of the proportions.Proportions expressed as percentages for reporting purposes. Ipsilateral ischemic stroke is defined as the clinical diagnosis of a focal neurological deficit due to cerebral ischemia clinically localizable within the internal carotid artery territory distally to the symptomatic occluded internal carotid artery that lasts for more than 24 hours. All stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours. Death is of any cause.

  within 2 yrs of randomization

Secondary Outcomes (9)

• All Stroke

  within 2 yrs of randomization

• Disabling Stroke

  within two years after randomization

• Fatal Stroke

  within 2 years after randomization

• Death

  within 2 years after randomization

• Modified Rankin 0-1

  at 2 years after randomization or end of trial. Worst case imputed for death and missing values

Other Outcomes (1)

• Any Stroke or Death Within 30 Days After Surgery

  within 30 days after surgery

Study Arms (2)

Surgical group

EXPERIMENTAL

Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy

Procedure: extracranial-intracranial bypass surgery

Non-surgical group

ACTIVE COMPARATOR

Receives best current practice medical therapy

Drug: best medical therapy

Interventions

extracranial-intracranial bypass surgery PROCEDURE

Surgical anastomosis of a superficial temporal artery branch to a middle cerebral artery branch through a small craniectomy plus best current practice medical therapy

Also known as: EC-IC Arterial Bypass, STA-MCA Bypass

Surgical group

best medical therapy DRUG

best current practice medical therapy

Non-surgical group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Vascular imaging demonstrating occlusion of one or both internal carotid arteries.
• Transient ischemic attack (TIA) or ischemic stroke in the hemispheric carotid territory of one occluded carotid artery.
• Most recent qualifying TIA or stroke occurring within 120 days prior to projected performance date of PET.
• Modified Barthel Index \> 12/20 (60/100).
• Language comprehension intact, motor aphasia mild or absent.
• Age 18-85 inclusive.
• Competent to give informed consent.
• Legally an adult.
• Geographically accessible and reliable for follow-up.

You may not qualify if:

• Non-atherosclerotic carotid vascular disease. Blood dyscrasias: Polycythemia vera ,essential thrombocytosis, sickle cell disease (SS or SC).
• Other non-atherosclerotic condition likely to cause focal cerebral ischemia.
• Any condition likely to lead to death within 2 years.
• Other neurological disease that would confound follow-up assessment.
• Pregnancy.
• Subsequent cerebrovascular surgery planned which might alter cerebral hemodynamics.
• Any condition which in the participating surgeon's judgment makes the subject an unsuitable surgical candidate.
• Participation in any other experimental treatment trial.
• Participation within the previous 12 months in any experimental study that included exposure to ionizing radiation.
• Acute, progressing or unstable neurological deficit. Neurological deficit must be stable for 72 hours prior to the performance of PET.
• If supplemental arteriography is required, allergy to iodine or x-ray contrast media, serum creatinine \> 3.0 mg/dl or other contraindication to arteriography.
• If aspirin is to be used as antithrombotic therapy in the perioperative period, those with allergy or contraindication to aspirin are ineligible.
• Medical indication for treatment with anticoagulant drugs, ticlopidine, clopidogrel or other antithrombotic medications such that these medications cannot be replaced with aspirin in the perioperative period as deemed necessary by the COSS neurosurgeon if the participant is randomized to surgical treatment.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Washington University School of Medicine: collaborator
• University of Iowa: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (6)

• Grubb RL Jr, Derdeyn CP, Fritsch SM, Carpenter DA, Yundt KD, Videen TO, Spitznagel EL, Powers WJ. Importance of hemodynamic factors in the prognosis of symptomatic carotid occlusion. JAMA. 1998 Sep 23-30;280(12):1055-60. doi: 10.1001/jama.280.12.1055.

  PMID: 9757852 BACKGROUND

• Derdeyn CP, Gage BF, Grubb RL Jr, Powers WJ. Cost-effectiveness analysis of therapy for symptomatic carotid occlusion: PET screening before selective extracranial-to-intracranial bypass versus medical treatment. J Nucl Med. 2000 May;41(5):800-7.

  PMID: 10809195 BACKGROUND

• Adams HP Jr, Powers WJ, Grubb RL Jr, Clarke WR, Woolson RF. Preview of a new trial of extracranial-to-intracranial arterial anastomosis: the carotid occlusion surgery study. Neurosurg Clin N Am. 2001 Jul;12(3):613-24, ix-x.

  PMID: 11390318 BACKGROUND

• Grubb RL Jr, Powers WJ, Derdeyn CP, Adams HP Jr, Clarke WR. The Carotid Occlusion Surgery Study. Neurosurg Focus. 2003 Mar 15;14(3):e9. doi: 10.3171/foc.2003.14.3.10.

  PMID: 15709726 BACKGROUND

• Grubb RL Jr, Powers WJ, Clarke WR, Videen TO, Adams HP Jr, Derdeyn CP; Carotid Occlusion Surgery Study Investigators. Surgical results of the Carotid Occlusion Surgery Study. J Neurosurg. 2013 Jan;118(1):25-33. doi: 10.3171/2012.9.JNS12551. Epub 2012 Oct 26.

  PMID: 23101451 DERIVED

• Powers WJ, Clarke WR, Grubb RL Jr, Videen TO, Adams HP Jr, Derdeyn CP; COSS Investigators. Extracranial-intracranial bypass surgery for stroke prevention in hemodynamic cerebral ischemia: the Carotid Occlusion Surgery Study randomized trial. JAMA. 2011 Nov 9;306(18):1983-92. doi: 10.1001/jama.2011.1610.

  PMID: 22068990 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient; Cerebral Infarction

Interventions

Cerebral Revascularization

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Brain Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Microsurgery

Results Point of Contact

• Title: William J. Powers, MD
• Organization: University of North Carolina at Chapel HIll

powersw@neurology.unc.edu

Study Officials

• William J. Powers, M.D.

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: January 8, 2002
• First Posted: January 9, 2002
• Study Start: July 1, 2002
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: March 27, 2012
• Results First Posted: March 26, 2012

Record last verified: 2012-03

Locations

US (1)