International Carotid Stenting Study "ICSS (CAVATAS-2)"

Completed

Phase 3 Results

Trial Description

To compare the risks and benefits of primary carotid stenting with those of conventional carotid endarterectomy in patients at high risk for stroke.

Interventions

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

Trial Design

Open, prospective, randomized, multicenter trial.

Patient Involvement

Prior to randomization, patients will receive routine hematology and blood chemistry panels, chest X-ray, echocardiogram (if indicated), brain CT or MRI, and one of the following angiographic procedures: bilateral, intra-arterial catheter carotid angiography, bilateral magnetic resonance carotid angiography with concordant ultrasound, bilateral spiral CT angiography with concordant ultrasound, or bilateral duplex and Doppler ultrasound scan. Other baseline data, including modified Rankin scale (MRS) score, current antiplatelet use, and blood pressure will be recorded. Eligible patients will be randomized into carotid endarterectomy and primary carotid stenting groups. The surgeries will be carried out according to standard protocol as soon as is feasible. All patients will receive appropriate anticoagulation or antiplatelet therapies, as well as any necessary drugs to control hyperlipidemia, hypertension, and to reduce smoking. All patients will receive carotid ultrasound studies at baseline, one month after treatment, and annually until the end of the study. Additional physician follow-up will occur 30 days after treatment, 6 months after randomization and then annually for the remainder of the study. Outcome events, Rankin score, and health status will be evaluated at 1 month, 6 months, and annually thereafter for a period of 2 - 5 years.

Outcomes

Type Measure Time Frame Safety Issue
Primary Incidence of mortality and debilitating (modified Rankin score (MRS) < 3 for 30 days after onset) stroke
Secondary Any stroke or myocardial infarction at 30 days post-treatment, any treatment-related cranial nerve palsy or hematoma, any restenosis (> 70%) on ultrasound follow-up, quality of life (assessed by EuroQol), and cost-effectiveness (cost per quality-adjusted life year (QALY)).

Sponsors

Stroke Association (UK), Sanofi-Synth&#233;labo and the European Union. University College London.