NCT00180518

ACCULINK for Revascularization of Carotids in High Risk Patients "The ARCHeR Trial"

Prospective, Non-Randomized, Multi-Center, Single-Arm Trial to Assess Safety & Efficacy of the Acculink Carotid Stent System With the Accunet Embolic Protection System in High-Risk Patients With Carotid Artery Lesions.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 581 (planned)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

1. To evaluate the safety and efficacy of the over-the-wire (OTW) ACCULINK (tm) System in patients deemed to be either at high risk or unsuitable for carotid endarterectomy (CEA) 2. To evaluate the efficacy of the OTW ACCUNET System in patients deemed to be either at high risk or unsuitable for carotid endarterectomy (CEA). 3. To demonstrate equivalence in the safety and performance of the RX ACCULINK Carotid Stent System and RX ACCUNET Embolic Protection System and the corresponding OTW devices.

Detailed description

The purpose of the study is to demonstrate equivalence in the safety and performance of the RX ACCUNET when used with the RX ACCULINK, to that of the ACCULINK and ACCUNET devices, in the treatment of high risk surgical patients and patients with anatomical risks who require treatment for carotid artery disease. Patients in ARCHeR RX will be followed after the index procedure at one, six and 12 months. Equivalence in safety will be demonstrated by comparing 30-day rates of DSMI for ARCHeR Amendment 2 and ARCHeR RX. Secondary analyses will be performed on the rate of ipsilateral stroke between 31 days and 12 months, target lesion revascularization at six and 12 months, acute device success for the RX ACCULINK and RX ACCUNET Systems, clinical success, and access site complications requiring treatment. Additionally, the stented segment will be evaluated by carotid duplex ultrasound at six and 12 months. Serious adverse events (SAE) of death or ipsilateral stroke that occur anytime during the follow-up period will be identified and reported, and will be adjudicated if indicated.

Conditions

• Carotid Atherosclerosis
• Carotid Artery Disease

Interventions

Type	Name	Description
DEVICE	Over-the-wire & Rapid Exchange ACCULINK (tm) Carotid Stent & ACCUNET (tm) embolic protection system	Two rapid exchange devices will be evaluated: the RX ACCUNET Embolic Protection System ("RX ACCUNET") and the RX ACCULINK Carotid Stent System ("RX ACCULINK"). The RX ACCUNET Embolic Protection System is intended to facilitate the placement of diagnostic and therapeutic devices during interventional procedures and to capture embolic material that may be present during carotid artery interventional procedures. The RX ACCULINK™ Carotid Stent System is intended for the treatment of carotid artery stenosis in the internal carotid artery (ICA), with or without involvement of the contiguous common carotid artery (CCA), in asymptomatic patients and symptomatic patients.

Timeline

• Start date: 2000-05-01
• Primary completion: 2003-10-01
• Completion: 2003-11-01
• First posted: 2005-09-16
• Last updated: 2008-09-12