Drug-Eluting Stents for the Treatment of Intracranial Atherosclerosis.

Completed

Phase N/A Results

Trial Description

To determine the feasibility and safety of using drug-eluting stents (DES) for patients with symptomatic intracranial atherosclerosis.

Interventions

  • Aspirin (stroke prevention) Drug
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
  • Clopidogrel (Plavix┬«)Drug
    Other Names: Plavix
    Intervention Desc: Antiplatelet agent
  • Stent, carotid Procedure/Surgery
    Intervention Desc: Intravascular procedure to maintain carotid artery patency

Trial Design

Prospective, clinical trial.

Patient Involvement

All of the patients were pretreated with 325 mg of aspirin and 75 mg of clopidogrel for >/=4 days before intervention, and all were given unfractionated heparin intraprocedurally and stopped postprocedurally. All patients were underwent thorough cerebral angiography, under local anesthesia, with brief neurological assessments performed throughout. Patients were discharged to home the following day on a regimen of 325 mg of aspirin lifelong and 75 mg of clopidogrel daily for 1 year.

Outcomes

Type Measure Time Frame Safety Issue
Primary Amount of reduction in stenosis severity to </=50% luminal narrowing without angiographic evidence of distal embolization, flow-limiting dissection, or contrast extrava-sation. Angiographic restenosis was defined as >/=50% stenosis within the stent or just outside the stent margins.

Sponsors

Johnson and Johnson Corporation.