SSYLVIA
Stenting of SYmptomatic Atherosclerotic Lesions in the Vertebral or Intracranial Arteries
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Status:
Trial complete. Results published in June of 2004.
Purpose:
To determine the safety and efficacy of a new balloon catheter and stenting device (Neurolink) in patients with symptomatic cerebrovascular disease.
Interventions:
Stent, vertebral
Intravascular procedure to maintain carotid artery patency
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Year Started:
2000
Year Presented:
2003
Design:
Selective, non-randomized, multi-center, prospective feasibility study.
Inclusion Criteria
Patients with symptomatic cerebral atherosclerosis >50% were eligible for this study.
Primary Outcome:
Death or stroke within 30 days, and stent placement resulting in < 50% stenosis.
Secondary Outcome:
Angiographic evaluation of stented area at 6 months, and target lesion-related stroke at one year.
Results:
Stroke rate at 30 days was 6.6%. Death rate at 30 days was 0. Six-month follow up showed recurring stenosis (> 50%) in 32.4% of 37 patients to receive a stent in intracranial arteries and 42.9% of the 14 patients to receive a stent in vertebral arteries. At one year, 4 of 55 patients (7.3%) of patients developed strokes related to the target lesion more than 30 days after stenting.
Source of Information:
Guidant press release (November 2000). Presented at the 28th International Stroke Conference (February 2003). Stroke. 2003;34:252. Stroke 2004;35:1388-1392.
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Web Links and Publications:
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This information last updated on: 10/18/2004
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