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

NCT00180518 | Completed Phase 2 DMC

• 1 other identifier: 99-706
• Study Type: interventional
• Target: 581
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 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. 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.

Conditions

Carotid Atherosclerosis; Carotid Artery Disease

Keywords

Carotid artery disease; High risk; High surgical risk

Outcome Measures

Primary Outcomes (1)

• All Stroke, death and MI

  within 30 days

Secondary Outcomes (7)

• Ipsilateral stroke

  between 31 days and 12 months

• 2. Target vessel revascularization

  six and 12 months

• 3. Ultrasound evaluation

  six and 12 months

• 4. Acute device success for the RX ACCULINK System

  Acute

• 5. Acute device success for the RX ACCUNET Embolic Protection System

  Acute

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

Over-the-wire & Rapid Exchange ACCULINK (tm) Carotid Stent & ACCUNET (tm) embolic protection system DEVICE

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age \>=18.
• Patient has no childbearing potential or a negative pregnancy test within 30 days of study procedure.
• Patient or legally authorized representative, and the patient's physician, agree to have the patient return for all required clinical contacts following study enrollment.
• Patient or legally authorized representative has been informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB)/Medical Ethics Committee (MEC) of the respective clinical site. (Sample consent - Appendix A-2).
• 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:
• Knowledge of two or more proximal or major diseased coronary arteries with \>=70% stenosis that have not, or cannot be revascularized;
• Unstable angina defined as rest angina with ECG changes;
• MI within the previous 30 days and current need for carotid artery revascularization
• Concurrent requirement for aortocoronary bypass or cardiac valve surgery within 30 days;
• Contralateral occlusion of the ICA;
• Currently on a list for major organ transplantation (i.e. heart, lung, liver, kidney) or is being evaluated for such;
• Ejection fraction \<30% or New York Heart Association (NYHA) Functional Class III or higher;
• FEV1 \<30% (Predicted);
• Dialysis-dependent renal failure;
• Uncontrolled diabetes defined as fasting glucose \>400 mg/dl and ketones \>2+;

You may not qualify if:

• Candidates will be ineligible for enrollment in the study if any one of the following conditions apply:
• Patient has an evolving stroke.
• Patient has history of intolerance or allergic reaction to any of the study medications or materials, including heparin, aspirin, baby aspirin, nitinol, or x-ray contrast.
• Patient has history of intolerance or allergic reaction to both ticlopidine and clopidogrel.
• Patient has active bleeding diathesis or coagulopathy or will refuse blood transfusions.
• Patient has a history of major ipsilateral stroke likely to confound study endpoints.
• Patient has severe dementia.
• Patient has a history of spontaneous intracranial hemorrhage within the past 12 months.
• Patient has had a recent (\<7 days) stroke of sufficient size (on CT or MRI) to place him or her at risk of hemorrhagic conversion during the procedure.
• Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days.
• Patient has Hgb \< 8 gm/dl (unless on dialysis), platelet count \< 50,000, uncorrected INR \> 1.5, or heparin-associated thrombocytopenia.
• Patient has any condition that precludes proper angiographic assessment or makes percutaneous arterial access unsafe (e.g. morbid obesity, sustained SBP \> 180 mm Hg.).
• Patient has had neurologic illness within the past two years characterized by fleeting or fixed neurologic deficit which cannot be distinguished from TIA or stroke (e.g. partial or secondarily generalized seizures; complicated or classic migraine; tumor or other space-occupying brain lesions; subdural hematoma, cerebral contusion or other post-traumatic lesions; intracranial infection; demyelinating disease; moderate to severe dementia; or intracranial hemorrhage).
• Patient is actively participating in another drug or device trial (IND or IDE) that has not completed the required protocol follow-up period. Patients may be enrolled only once in the ARCHeR clinical trial and may not participate in any other clinical trial during the ARCHeR follow-up period.
• Patient or patient's legally authorized representative is unable to understand and cooperate with study procedures or provide informed consent.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Related Publications (7)

• Naylor AR. Regarding "Protected carotid stenting in high-surgical-risk patients: the ARCHeR results". J Vasc Surg. 2007 Jan;45(1):222-3; author reply 223-4. doi: 10.1016/j.jvs.2006.08.089. No abstract available.

  PMID: 17210414 BACKGROUND

• Gray WA, Hopkins LN, Yadav S, Davis T, Wholey M, Atkinson R, Cremonesi A, Fairman R, Walker G, Verta P, Popma J, Virmani R, Cohen DJ; ARCHeR Trial Collaborators. Protected carotid stenting in high-surgical-risk patients: the ARCHeR results. J Vasc Surg. 2006 Aug;44(2):258-68. doi: 10.1016/j.jvs.2006.03.044.

  PMID: 16890850 BACKGROUND

• Schonholz CJ, Uflacker R, Parodi JC, Hannegan C, Selby B. Is there evidence that cerebral protection is beneficial? Clinical data. J Cardiovasc Surg (Torino). 2006 Apr;47(2):137-41.

  PMID: 16572087 BACKGROUND

• Kasirajan K. What is the latest in inventory for carotid stenting and cerebral protection? Perspect Vasc Surg Endovasc Ther. 2005 Jun;17(2):135-41. doi: 10.1177/153100350501700217.

  PMID: 16110380 BACKGROUND

• Gray WA. Endovascular treatment of extra-cranial carotid artery bifurcation disease. Minerva Cardioangiol. 2005 Feb;53(1):69-77.

  PMID: 15788981 BACKGROUND

• Gray WA. A cardiologist in the carotids. J Am Coll Cardiol. 2004 May 5;43(9):1602-5. doi: 10.1016/j.jacc.2003.11.051.

  PMID: 15120818 BACKGROUND

• Illig KA, Zhang R, Tanski W, Benesch C, Sternbach Y, Green RM. Is the rationale for carotid angioplasty and stenting in patients excluded from NASCET/ACAS or eligible for ARCHeR justified? J Vasc Surg. 2003 Mar;37(3):575-81. doi: 10.1067/mva.2003.79.

  PMID: 12618695 BACKGROUND

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• L. Nelson Hopkins, M.D.

  Millard Fillmore Hospital, Buffalo, NY

  PRINCIPAL INVESTIGATOR

• Mark H. Wholey, MD

  Shadyside Medical Center, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: May 1, 2000
• Primary Completion: October 1, 2003
• Study Completion: November 1, 2003
• Last Updated: September 12, 2008

Record last verified: 2008-09