NCT00106938

Carotid Angioplasty and Stenting Versus Endarterectomy in Asymptomatic Subjects Who Are at Standard Risk for Carotid Endarterectomy With Significant Extracranial Carotid Stenotic Disease (ACT I)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,663 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

The study is being conducted to demonstrate the non-inferiority of carotid artery stenting (CAS) using the Emboshield® Embolic Protection System with the Xact® Carotid Stent System to carotid endarterectomy (CEA) for the treatment of asymptomatic extracranial carotid atherosclerotic disease.

Detailed description

Randomization for ACT 1 employs a 3:1 ratio of CAS versus CEA. A lead-in phase of up to 400 carotid stent subjects will provide investigators experience with the study devices prior to pivotal enrollment.

Conditions

• Carotid Artery Disease
• Carotid Stenosis
• Stroke
• Atherosclerosis

Interventions

Type	Name	Description
DEVICE	Carotid artery stenting with filter (interventional)	Carotid artery stenting with filter (interventional)
PROCEDURE	Carotid artery endarterectomy (surgical)	Carotid artery endarterectomy (surgical)

Timeline

• Start date: 2005-04-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2005-04-04
• Last updated: 2017-07-19
• Results posted: 2014-10-21

Locations

62 sites across 1 country: United States