NCT00403078

Brief Summary

The primary objective of this study is to assess the outcomes of stenting with distal protection in the treatment of obstructive carotid artery disease. The devices to be utilized are the Cordis PRECISE® Nitinol Stent Systems (5.5F and 6F) and the Cordis ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21,008

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2006

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 23, 2006

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

August 10, 2020

Status Verified

August 1, 2020

Enrollment Period

7.8 years

First QC Date

November 20, 2006

Last Update Submit

August 6, 2020

Conditions

Carotid Artery Disease

Keywords

Carotid Artery Stenting (Endovascular)

Outcome Measures

Primary Outcomes (1)

  • Any death, stroke or any MI

    up to 30-days post-procedure

Secondary Outcomes (3)

  • Assess the consistency of MAE rates of stenting with distal protection in the treatment of obstructive carotid artery disease among high, medium and low volume centers with physicians who have validated CASES training levels of 1, 2, 2P or 3

    30 days

  • Assess the real-world cost-effectiveness of carotid artery stenting in subjects enrolled

    Every follow-up where a PRO instrument QoL was assessed

  • Estimate MAE (death and ipsilateral stroke) rate in a subset of the planned total enrollment

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population will consist of high-surgical risk patients with atherosclerotic disease of the carotid artery(ies) from up to 350 clinical sites in the US and Canada.

You may qualify if:

  • High-surgical risk patients to be treated consistent with IFU labeling
  • The patient or legally authorized representative has signed a written informed consent and HIPAA authorization, prior to the procedure, using a form that is approved by the Institutional Review Board or Medical Ethics Committee.

You may not qualify if:

  • Patients not treated per the IFU
  • Patients who are contraindicated per the IFU
  • Patients previously enrolled in the study
  • Patients requiring stenting of in-stent restenosis after CAS
  • Inability or refusal to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Iowa Clinic, Heart & Vascular Care

West Des Moines, Iowa, 50266, United States

Location

Bryan LGH Heart Institute

Lincoln, Nebraska, 68506, United States

Location

Harrisburg Hospital

Harrisburg, Pennsylvania, 17110, United States

Location

The Heart Center, PC

Kingsport, Tennessee, 37660, United States

Location

Related Publications (2)

  • Massop D, Dave R, Metzger C, Bachinsky W, Solis M, Shah R, Schultz G, Schreiber T, Ashchi M, Hibbard R; SAPPHIRE Worldwide Investigators. Stenting and angioplasty with protection in patients at high-risk for endarterectomy: SAPPHIRE Worldwide Registry first 2,001 patients. Catheter Cardiovasc Interv. 2009 Feb 1;73(2):129-36. doi: 10.1002/ccd.21844.

    PMID: 18924164RESULT

  • Qureshi O, Mena-Hurtado C, Romain G, Cleman J, Callegari S, Smolderen KG. Applying a Random Forest Approach in Predicting Health Status in Patients with Carotid Artery Stenosis 30 Days Post Stenting. Stroke Vasc Interv Neurol. 2025 Sep 26;5(6):e001938. doi: 10.1161/SVIN.125.001938. eCollection 2025 Nov.

    PMID: 41608717DERIVED

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Rajesh Dave, MD

    Harrisburg Hospital, 2808 Old Post Rd., Harrisburg, PA 17110

    PRINCIPAL INVESTIGATOR

  • Robert Hibbard, MD

    Bryan LGH Heart Institute, 1500 South 48th St, Suite 400, Lincoln, NE 68506

    PRINCIPAL INVESTIGATOR

  • Douglas Massop, MD

    Iowa Clinic-Heart and Vascular Care, 5950 University Ave, West Des Moines, IA 50266

    PRINCIPAL INVESTIGATOR

  • Christopher Metzger, MD

    The Heart Center, PC, 2050 Meadowview Parkway, Kingsport, TN 37660

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2006

First Posted

November 23, 2006

Study Start

October 1, 2006

Primary Completion

July 1, 2014

Study Completion

November 1, 2014

Last Updated

August 10, 2020

Record last verified: 2020-08

Locations

US(5)