Effects of Carotid Stent Design on Cerebral Embolization

NCT00830232 | Completed Results

• 1 other identifier: IRB#08-035
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the proposed study is to contrast the relative efficacy of closed-cell stents versus open-cell stents in preventing periprocedural cerebral embolization in high-risk patients with symptomatic and asymptomatic extracranial carotid stenosis undergoing carotid artery stenting (CAS).

Conditions

Stroke; Carotid Stenosis

Keywords

Stroke; Carotid stenosis; stents

Outcome Measures

Primary Outcomes (1)

• Transcranial Doppler Counts of Micro-embolic Signals in the Ipsilateral Middle Cerebral Artery.

  Bilateral transcranial Doppler scan monitoring of the anterior and middle cerebral arteries was performed using a PMD150-ST3 digital transcranial Doppler pulsed-wave ultrasound scan system (Spencer Technologies, Seattle, Wash) with 2-MHz probes located over the temporal bones above the zygomatic arch. Isolated microembolic signals (MES) were identified from Doppler spectras according to the criteria given by the Consensus Committee of the Ninth International Cerebral Hemodynamic Symposium. If the number of MES was too high to be counted separately, heartbeats with microemboli were counted as microembolic showers. To avoid confusion, MES detected during contrast injection were excluded from the analysis. For analysis purposes, the procedure was divided into the following phases: lesion crossing, filter deployment, IVUS examination, predilation, stent deployment, postdilatation (when applicable), and filter removal.

  First 24 hours after implantation of carotid stent

Secondary Outcomes (2)

• Composite of Any Stroke, Myocardial Infarction or Death

  within 30 days after the carotid stenting procedure

• Subclinical Cerebral Embolization Assessed by Brain Diffusion-weighted MRI

  within 24 hours after carotid artery stenting

Study Arms (2)

Closed-cell stent (Xact stent)

ACTIVE COMPARATOR

For patients randomized to the closed-cell stent group, the Xact closed-cell stents were used. The Xact stent is a FDA approved device.

Device: closed-cell stent (Xact stent)

Open-cell stent (Acculink carotid)

ACTIVE COMPARATOR

For patients randomized to the open-cell stent group, the Acculink carotid stent was used. The Acculink stent is a FDA approved device.

Device: Open-cell stent (Acculink carotid)

Interventions

closed-cell stent (Xact stent) DEVICE

Patients enrolled in this study arm underwent for carotid stenting using closed stent cell. The graft used in this groups was the Xact closed-cell stent. This type of device is rigid device with dense conposition of the nitinol rigns. Carotid stenting was used on standard fashion using filters as embolic protection device.

Also known as: Carotid artery angioplasty

Closed-cell stent (Xact stent)

Open-cell stent (Acculink carotid) DEVICE

Patients enrolled in this study arm underwent for carotid stenting using open stent cell stents. This type of stent is a tube shaped graft composed of flexible nitinol rings. The device used in this group was the Acculinx open-cell stent. Stenting procedure eas performed on standard fashion.Filters were used as embolic protection device.

Also known as: Carotid artery angioplasty

Open-cell stent (Acculink carotid)

Eligibility Criteria

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

You may qualify if:

• Subject is at high risk for carotid endarterectomy due to either anatomic or co-morbid conditions; AND
• Symptomatic patients (TIA or non-disabling stroke within 6 months of the procedure), with carotid stenosis ≥ 50% as diagnosed by angiography, using NASCET methodology (50); OR
• Asymptomatic patients with carotid stenosis ≥ 80% as diagnosed by angiography, using NASCET methodology

You may not qualify if:

• Conditions that interfere with the evaluation of endpoints
• Subject has anticipated or potential sources of cardiac emboli
• Subject plans to have a major surgical procedure within 30 days after the index procedure.
• Subject has intracranial pathology that makes the subject inappropriate for study participation.
• Subject has a total occlusion of the ipsilateral carotid artery (i.e., CCA).
• Severe circumferential lesion calcification that may restrict the full deployment of the carotid stent.
• Carotid stenosis located distal to the target stenosis that is more severe than the target stenosis.

Sponsors & Collaborators

• Dallas VA Medical Center: lead

Study Sites (1)

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

Related Publications (1)

• Timaran CH, Rosero EB, Higuera A, Ilarraza A, Modrall JG, Clagett GP. Randomized clinical trial of open-cell vs closed-cell stents for carotid stenting and effects of stent design on cerebral embolization. J Vasc Surg. 2011 Nov;54(5):1310-1316.e1; discussion 1316. doi: 10.1016/j.jvs.2011.05.013. Epub 2011 Jul 1.

  PMID: 21723064 DERIVED

MeSH Terms

Conditions

Stroke; Carotid Stenosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Carotid Artery Diseases; Arterial Occlusive Diseases

Limitations and Caveats

1\. Small sample size 2.randomization did not eliminate all pretreatment differences between groups because of the small sample size.3.All patients underwent Stenting under filter embolic protection.

Results Point of Contact

• Title: Dr. Carlos H Timaran
• Organization: Dallas VA Medical Center

carlos.timaran@va.gov

2148570336

Study Officials

• Carlos H Timaran, MD

  Dallas VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular and Endovascular Surgeon

Study Record Dates

• First Submitted: January 26, 2009
• First Posted: January 27, 2009
• Study Start: December 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: February 1, 2012
• Last Updated: February 5, 2020
• Results First Posted: March 27, 2014

Record last verified: 2020-01

Locations

US (1)