Stent-protected Percutaneous Angioplasty of the Carotid vs. Endarterectomy "SPACE"

Completed

Phase N/A Results

Trial Description

To compare the safety and prophylactic efficacies of stent-protected percutaneous angioplasty of the carotid artery (SPAC) and carotid endarterectomy (CEA) against stroke and other vascular events in patients with symptomatic carotid stenosis.

Interventions

  • Endarterectomy, carotid (CEA)Procedure/Surgery
    Intervention Desc: Surgical therapy to remove atherosclerotic plaque in narrowed carotid arteries.
  • Angioplasty, carotid Procedure/Surgery
    Intervention Desc: Intravascular procedure to dilate stenotic carotid arteries.
  • Stent, carotid Procedure/Surgery
    Intervention Desc: Intravascular procedure to maintain carotid artery patency

Trial Design

Prospective, randomized, independently-controlled, multi-center trial.

Patient Involvement

Prior to enrollment, all patients will undergo Duplex sonography. Eligible patients will be randomized to receive either SPAC or CEA. If patients have bilateral stenosis, they will be randomized to receive treatment on the side associated with their most recent symptoms. Prior to their surgeries, all patients will receive either aspirin 50 - 325 mg/day or Clopidogrel 75 mg/day, as well as enoxaparin sodium 100 IE/kg/day or another low-molecular-weight heparin in the same dosage. All patients must be surgically treated within 14 days of randomization. Following treatment, patients will receive either aspirin 50-325 mg/day, clopidogrel 75 mg/day, or ticlopidine 500 mg/day, and, if necessary, phenprocoumon dosed to achieve an international normalized ratio (INR) of 2 - 3. Patients will be followed-up by study clinicians at 6 days, 1, 6, 12, and 24 months post-treatment. At each follow-up visit, patients will be evaluated for the occurrence of all endpoints, and for clinical impairment, measured by the National Institute of Health Stroke Scale (NIHSS) and the MRS. An interim analysis will be performed after 2 years have passed or 900 patients have been treated, whichever happens first.

Outcomes

Type Measure Time Frame Safety Issue
Primary 30-day incidence of ipsilateral cerebrovascular events (cerebral infarction and/or hemorrhage with symptoms lasting for more than 24 hours); 30-day mortality.
Secondary 24-month incidence of death or ipsilateral stroke; frequency of high-grade restenosis (>=70% by Duplex sonography) of the treated artery at 6, 12, and 24 months; number of technical complications (MI, vascular occlusion, residual stenosis >= 70%) at 6 and 30 days; stroke in either hemisphere at 30 days and 24 months post-treatment.

Sponsors

BMBF (German Ministry of Science), DFG (German Research Council), Guidant, Boston Scientific.