Clinical Trial: Comparing Carotid Stenting With Endarterectomy in Severe Asymptomatic Carotid Stenosis

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Randomized Evaluation of Short Term and Long Term Outcome After Endovascular Repair by Stenting of Carotid Artery Stenosis in Patients With Severe (70% and Higher) Asymp

Brief Summary:

Purpose of this study:

Primary:

• Comparison of cardiovascular mortality and morbidity which includes cardiac and neurological morbidity (TIA and CVA) in the two invasive treatments of asymptomatic carotid artery stenosis

Secondary:

  • Comparison of non cardiovascular morbidity caused by the two invasive techniques

    1. morbidity at the site of incision (infection or local hematoma)
    2. damage to cranial nerves (hypoglossus, vagus)
    3. brain hyperperfusion which is defined as severe headache which is not responsive to analgesics with or without nausea and vomiting.
    4. events of bradycardia within the first 24 hours, clinically evident and/or silent
  • microembolic brain events immediately after the procedure and their relationship with morbidity and/or mortality due to TIA's or CVA's
  • the change in the stenotic carotid artery at the time of follow up with duplex of neck arteries
  • the comparison of the affect of the two procedures on patient life style

Detailed Summary:

Background: the surgical treatment of severe carotid artery stenosis (>70%) has been proven effective in prevention of cerebral vascular events in asymptomatic patients as compared with non invasive treatment (1, 5, 7). The currently accepted surgical treatment is called endarterectomy and includes surgery under regional and general anesthesia, in which the neck is opened, the common carotid artery, the bifurcation and the internal and external carotid artery are exposed, 5000 units of intravenous (IV) heparin is given and the arteries are occluded. The diseased artery is opened and the atherosclerotic plaque is excised, after the artery is cleaned the opening is sutured and the blood supply is reestablished. At the end of the procedure the incision is closed. The patient is transferred to recovery for four hours of surveillance, and 500 units/hour of heparin IV is started, which is continued for 12 hours. After an additional day of surveillance in the department the patient is discharged home. Two weeks after the operation the patient is invited to the out patient clinic for wound surveillance and to take out the skin staples. After which the patient is under surveillance after 3 months, 6 months, and then yearly, which involves a physical examination by a physician and a duplex examination of carotid arteries. A regiment of 100mg of Aspirin per day is initiated at the time of diagnosis. Complications associated with this procedure: a 1-3% of patients develop a transient ischemic accident (TIA) or cerebrovascular accident (CVA), cardiac complications depending on individual risk factors (0.5%), bleeding and infection at incision site is at the rate of 5%, 2-8% of patients suffer from cranial nerve damage (including hypoglossus and vagus), 2-3% of patients suffer from brain hyperperfusion, finally, stenosis recurs in 10-15% of patients.

Recently endovascular technique
Sponsor: Carmel Medical Center

Current Primary Outcome: comparison of cardiovascular mortality and morbidity which includes cardiac and neurological morbidity (TIA and CVA) in the two invasive treatments of asymptomatic carotid artery stenosis [ Time Frame: 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • incision site morbidity [ Time Frame: 2 years ]
  • cranial nerves damage [ Time Frame: 2 years ]
  • brain hyperperfusion [ Time Frame: 2 years ]
  • bradycardia within the first 24 hours [ Time Frame: 2 years ]
  • microembolic brain events [ Time Frame: 2 years ]
  • long term recurrence [ Time Frame: 2 years ]
  • effect on patient life style [ Time Frame: 2 years ]


Original Secondary Outcome: Same as current

Information By: Carmel Medical Center

Dates:
Date Received: September 29, 2008
Date Started: January 2009
Date Completion: September 2015
Last Updated: October 25, 2014
Last Verified: October 2014