Carotid Artery DiseaseNCT00403078
SAPPHIRE Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy
An observational study of Carotid Artery Disease, run by Cordis US Corp. at 5 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Disease
- How many people
- 21,008 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2006to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Harrisburg Hospital
Harrisburg, Pennsylvania, 17110
The Heart Center, PC
Kingsport, Tennessee, 37660
Bryan LGH Heart Institute
Lincoln, Nebraska, 68506
Christiana Care Health Services
Newark, Delaware, 19713
Iowa Clinic, Heart & Vascular Care
West Des Moines, Iowa, 50266
About this study
Official title: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy (SAPPHIRE Worldwide)
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).
Read the detailed description
Carotid Artery Stenting
- Conditions
- Carotid Artery Disease
- Keywords
- Carotid Artery Stenting (Endovascular)
- Medical subject headings
- Carotid Artery Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Any death, stroke or any MI
Measured: 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
Measured: 30 days
Assess the real-world cost-effectiveness of carotid artery stenting in subjects enrolled
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2006 (estimated)
- Study startOct 2006
- Primary completionJul 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 21,008 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rajesh Dave, MD, Principal investigator, Harrisburg Hospital, 2808 Old Post Rd., Harrisburg, PA 17110Robert Hibbard, MD, Principal investigator, Bryan LGH Heart Institute, 1500 South 48th St, Suite 400, Lincoln, NE 68506Douglas Massop, MD, Principal investigator, Iowa Clinic-Heart and Vascular Care, 5950 University Ave, West Des Moines, IA 50266Christopher Metzger, MD, Principal investigator, The Heart Center, PC, 2050 Meadowview Parkway, Kingsport, TN 37660
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403078
- Sponsor's protocol ID
- P06-3603
- Status last verified
- Aug 2020
- First submitted
- 20 Nov 2006
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18924164Qureshi 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.
PubMed 41608717
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy (SAPPHIRE Worldwide)
- ClinicalTrials.gov ID
- NCT00403078
- Acronym / sponsor ID
- P06-3603
- Conditions
- Carotid Artery Disease
- Keywords
- Carotid Artery Stenting (Endovascular)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21,008 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Jul 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 23 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Carotid Artery Stenting
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Any death, stroke or any MI
Time frame: up to 30-days post-procedure
3 secondary outcomes
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
Time frame: 30 days
Assess the real-world cost-effectiveness of carotid artery stenting in subjects enrolled
Time frame: 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
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
- Results publication: PubMed 18924164Massop 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.
- Derived from this study: PubMed 41608717Qureshi 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.
Related trials for Carotid Artery Disease
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
Not yet recruiting
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
Congenital Heart Disease, Cardiac Output
Not yet recruitingObservational study
Common Carotid Artery-Renal Artery-Femoral Artery Survey for Hypertension
Hypertension, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajesh Dave, MD principal investigator
Harrisburg Hospital, 2808 Old Post Rd., Harrisburg, PA 17110
Robert Hibbard, MD principal investigator
Bryan LGH Heart Institute, 1500 South 48th St, Suite 400, Lincoln, NE 68506
Douglas Massop, MD principal investigator
Iowa Clinic-Heart and Vascular Care, 5950 University Ave, West Des Moines, IA 50266
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Disease, run by Cordis US Corp. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any death, stroke or any MI (time frame: up to 30-days post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00403078, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2020.