Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT00180518
Status:
COMPLETED
Last Update Posted:
2008-09-12
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ACCULINK for Revascularization of Carotids in High Risk Patients "The ARCHeR Trial"
Sponsor:
Abbott Medical Devices
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: