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| Sponsor: | Abbott Vascular |
|---|---|
| Information provided by: | Abbott Vascular |
| ClinicalTrials.gov Identifier: | NCT00180518 |
Purpose
| Condition | Intervention | Phase |
|---|---|---|
|
Carotid Atherosclerosis Carotid Artery Disease |
Device: Over-the-wire & Rapid Exchange ACCULINK (tm) Carotid Stent & ACCUNET (tm) embolic protection system |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
| Estimated Enrollment: | 581 |
| Study Start Date: | May 2000 |
| Study Completion Date: | November 2003 |
| Primary Completion Date: | October 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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) To evaluate the efficacy of the OTW ACCUNET System in patients deemed to be either at high risk or unsuitable for carotid endarterectomy (CEA). 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. |
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. |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient must meet two or more of the criteria listed in a-e OR one or more of the criteria listed in f-q below:
1. Patient has a discrete lesion located in the ICA (with or without involvement of the contiguous CCA).
2. Carotid stenosis must be >= 50% by angiography (symptomatic patient) or >= 80% by angiography (asymptomatic patient).
3. Target ICA vessel reference diameter must be >=4.0 mm and =<9.0 mm by angiography.
NOTE: Patients with bilateral carotid stenosis are eligible. Management of the non-study stenosis may be done in accordance with local Principal Investigator recommendation. Treatment of the non-study artery must take place either >30 days before or >30 days after the study procedure is completed.
Specific for the ACCUNET System 4. Expected ability to deliver the ACCUNET System distal to the lesion (absence of excessive tortuosity) and an available straight or mildly angulated segment >= 4 cm, by angiography, in the distal ICA (prior to the petrous portion of the vessel) in which to place the embolic protection device.
5. The diameter of the straight or mildly angulated segment, in the distal ICA prior to the petrous portion of the vessel, must be >= 3.25 mm and =< 7.5 mm by angiography.
Exclusion Criteria:
Candidates will be ineligible for enrollment in the study if any one of the following conditions apply:
Anatomic Exclusions
Contacts and Locations| Principal Investigator: | L. Nelson Hopkins, M.D. | Millard Fillmore Hospital, Buffalo, NY |
| Principal Investigator: | Mark H. Wholey, MD | Shadyside Medical Center, Pittsburgh, PA |
More Information
| Responsible Party: | Abbott Vascular |
| ClinicalTrials.gov Identifier: | NCT00180518 History of Changes |
| Other Study ID Numbers: | 99-706 |
| Study First Received: | September 13, 2005 |
| Last Updated: | September 10, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
Carotid artery disease High risk High surgical risk |
|
Atherosclerosis Carotid Artery Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
Cardiovascular Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |