Carotid Artery Disease Clinical Trial
Official title:
Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy (SAPPHIRE Worldwide)
NCT number | NCT00403078 |
Other study ID # | P06-3603 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2006 |
Est. completion date | November 2014 |
Verified date | August 2020 |
Source | Cordis Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 21008 |
Est. completion date | November 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Harrisburg Hospital | Harrisburg | Pennsylvania |
United States | The Heart Center, PC | Kingsport | Tennessee |
United States | Bryan LGH Heart Institute | Lincoln | Nebraska |
United States | Christiana Care Health Services | Newark | Delaware |
United States | Iowa Clinic, Heart & Vascular Care | West Des Moines | Iowa |
Lead Sponsor | Collaborator |
---|---|
Cordis Corporation |
United States,
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 fir — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Any death, stroke or any MI | up to 30-days post-procedure | ||
Secondary | 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 | ||
Secondary | Assess the real-world cost-effectiveness of carotid artery stenting in subjects enrolled | Every follow-up where a PRO instrument QoL was assessed | ||
Secondary | Estimate MAE (death and ipsilateral stroke) rate in a subset of the planned total enrollment | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02124928 -
Morphological and Serological Criteria of Plaque Vulnerability: Risk Assessment for Symptomatic and Asymptomatic Carotid Artery Stenosis
|
N/A | |
Active, not recruiting |
NCT01597453 -
NOR-SYS: The Norwegian Stroke in the Young Study
|
N/A | |
Completed |
NCT00744523 -
Proximal Protection With The Mo.Ma Device During Carotid Stenting
|
N/A | |
Completed |
NCT00231231 -
Carotid Artery Stenting With Emboli Protection Surveillance-Post-Marketing Study (CASES-PMS)
|
Phase 3 | |
Completed |
NCT00597974 -
Neurological Outcome With Carotid Artery Stenting
|
N/A | |
Completed |
NCT00587717 -
The Acute Effect of Statins on Inflammatory Markers of Athersclerotic Tissue
|
N/A | |
Completed |
NCT02536378 -
POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE
|
||
Completed |
NCT02126982 -
Salts of Clopidogrel: Investigation to ENsure Clinical Equivalence
|
||
Active, not recruiting |
NCT01445613 -
Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy
|
N/A | |
Terminated |
NCT01414387 -
Effects of Cerebral Protection With Filters vs. Flow Reversal on Cerebral Embolization After Carotid Artery Stenting
|
N/A | |
Completed |
NCT00406055 -
CHOICE: Carotid Stenting For High Surgical-Risk Patients
|
Phase 4 | |
Terminated |
NCT01968226 -
TRACER RGD-K5 Carotid Plaque Imaging Study
|
Phase 2 | |
Completed |
NCT01685567 -
Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure
|
Phase 3 | |
Completed |
NCT00402740 -
Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA) (PROTECT)
|
N/A | |
Completed |
NCT00287508 -
Emboshield® and Xact® Post Approval Carotid Stent Trial (The EXACT Study)
|
Phase 4 | |
Completed |
NCT00178672 -
A Single Center of Carotid Stenting With Distal Protection for the Treatment of Obstructive Carotid Artery Disease
|
Phase 4 | |
Recruiting |
NCT02850588 -
SVS VQI TransCarotid Revascularization Surveillance Project
|
||
Completed |
NCT02759653 -
Norwegian Carotid Plaque Study
|
||
Withdrawn |
NCT01042912 -
Frequency Analysis of Carotid Artery Disease
|
N/A | |
Completed |
NCT00530504 -
Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study
|
N/A |