Evaluation of the medtronic exponent self-expanding carotid stent system with the medtronic guardwire temporary occlusion and aspiration system in the treatment of carotid stenosis: combined from the MAVErIC (Medtronic AVE Self-expanding CaRotid Stent System with distal protection In the treatment of Carotid stenosis) I and MAVErIC II trials

Stroke. 2010 Feb;41(2):e102-9. doi: 10.1161/STROKEAHA.109.564161. Epub 2009 Dec 24.


Background and purpose: Embolic protection devices and improved stent technology have advanced the endovascular treatment of carotid artery disease. A combined analysis was performed of the MAVErIC (Medtronic AVE Self-expanding CaRotid Stent System with distal protection) I and II trials to evaluate the safety and feasibility of this system among patients at high risk for surgical endarterectomy.

Methods: Four hundred ninety-eight patients were enrolled in the MAVErIC I (99 patients) and MAVErIC II (399 patients) studies from June 2001 to October 2004. The results were pooled for statistical analysis of a common primary end point, the 365-day rate of major adverse events. Clinical follow-up took place at 30 days, 6 months, and 365 days postprocedure.

Results: The 365-day major adverse event rate, defined as death, stroke, or myocardial infarction within 30 days, and death, ipsilateral stroke, or myocardial infarction from days 31 to 365 was 12.5%. The incidence of neurological death through 365 days was 1.1%. The 30-day major adverse event rate was 5.4%. Subgroup analyses showed no notable differences in the 365-day major adverse event rate for symptomatic patients compared with asymptomatic patients.

Conclusions: Treatment of carotid artery disease with carotid artery stenting with a self-expanding stent and distal embolic protection results in a low 30-day adverse event rate, including the occurrence of stroke in patients at high risk for carotid endarterectomy.

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Angioplasty, Balloon / instrumentation*
  • Angioplasty, Balloon / methods
  • Angioplasty, Balloon / statistics & numerical data
  • Carotid Stenosis / complications
  • Carotid Stenosis / physiopathology
  • Carotid Stenosis / therapy*
  • Durable Medical Equipment / standards
  • Durable Medical Equipment / statistics & numerical data
  • Female
  • Humans
  • Intracranial Embolism / etiology
  • Intracranial Embolism / physiopathology
  • Intracranial Embolism / prevention & control*
  • Male
  • Middle Aged
  • Outcome Assessment, Health Care
  • Patient Selection
  • Postoperative Complications / epidemiology
  • Postoperative Complications / physiopathology
  • Prostheses and Implants / standards
  • Prostheses and Implants / statistics & numerical data
  • Prosthesis Implantation / instrumentation
  • Prosthesis Implantation / methods
  • Stents / adverse effects
  • Stents / standards*
  • Stents / statistics & numerical data
  • Stroke / physiopathology
  • Stroke / prevention & control*
  • Stroke / therapy*
  • Treatment Outcome