We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy (SAPPHIRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00231270
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : April 24, 2008
Sponsor:
Information provided by:
Cordis Corporation

Tracking Information
First Submitted Date  ICMJE October 3, 2005
First Posted Date  ICMJE October 4, 2005
Last Update Posted Date April 24, 2008
Study Start Date  ICMJE August 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2007)
  • composite of major adverse clinical events including death, any stroke, and/or myocardial infarction at 30-days post-procedure [ Time Frame: 30-days post-procedure ]
  • The same 30-day composite of major adverse clinical events plus death and/or ipsilateral stroke between 31-days and 12-months post-procedure. [ Time Frame: Between day 31 and 12-months post-procedure. ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 3, 2005)
  • · composite of major adverse clinical events including death, any stroke, and/or myocardial infarction at 30-days post-procedure;
  • · The same 30-day composite of major adverse clinical events plus death and/or ipsilateral stroke between 31-days and 12-months post-procedure.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2007)
  • successful stent deployment at the target lesion in a variety of carotid morphologies
  • successful filter deployment and retrieval
  • <30% residual stenosis determined by angiography immediately post-stent placement and post-dilatation
  • endovascular access site complications, such as the need for surgical repair or blood transfusion
  • surgical site complications, such as wound infection or hematoma, that prolong hospital stay, require incision and drainage, or need blood transfusion
  • patency (< 50% restenosis) of the Cordis Nitinol Stent as determined by carotid ultrasound imaging within 48 hours, at six months, and one, two and three years post-procedure
  • independent neurologic assessments at 24 + 12 hours, thirty days, six months, and one, two and three years post-procedure (in addition to stroke scales, the development of any cranial nerve deficits will be recorded) - persistent neurologic deficits
  • thirty (30)-day and six (6)-month evaluation for disabling stroke [ Time Frame: Day 30 and 6 months ]
  • six (6)-month, one (1)-year, two (2)-year and three (3)-year composite of major adverse clinical events including death and ipsilateral stroke [ Time Frame: 6 month and 1, 2, 3yr ]
  • safety assessment of the ANGIOGUARD XP Emboli Capture Guidewire Device
  • presence of trapped material as determined by the interventionalist's visual inspection of the ANGIOGUARD XP filter basket following recapture at the completion of the procedure
  • laboratory analysis of trapped material contained in the ANGIOGUARD XP filter basket
Original Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2005)
  • · successful stent deployment at the target lesion in a variety of carotid morphologies
  • · successful filter deployment and retrieval
  • · <30% residual stenosis determined by angiography immediately post-stent placement and post-dilatation
  • · endovascular access site complications, such as the need for surgical repair or blood transfusion
  • · surgical site complications, such as wound infection or hematoma, that prolong hospital stay, require incision and drainage, or need blood transfusion
  • · patency (< 50% restenosis) of the Cordis Nitinol Stent as determined by carotid ultrasound imaging within 48 hours, at six months, and one, two and three years post-procedure
  • · independent neurologic assessments at 24 + 12 hours, thirty days, six months, and one, two and three years post-procedure (in addition to stroke scales, the development of any cranial nerve deficits will be recorded) - persistent neurologic deficits
  • · thirty (30)-day and six (6)-month evaluation for disabling stroke
  • · six (6)-month, one (1)-year, two (2)-year and three (3)-year composite of major adverse clinical events including death and ipsilateral stroke
  • · safety assessment of the ANGIOGUARD XP Emboli Capture Guidewire Device
  • · presence of trapped material as determined by the interventionalist's visual inspection of the ANGIOGUARD XP filter basket following recapture at the completion of the procedure
  • · laboratory analysis of trapped material contained in the ANGIOGUARD XP filter basket
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy (SAPPHIRE)
Official Title  ICMJE Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy
Brief Summary The primary objective of this study is to compare the safety and effectiveness of the Cordis Nitinol Carotid Stent and Delivery Systems (5.5 F and 7 F) with the ANGIOGUARD XP distal protective device to CEA in the treatment of carotid artery disease in patients at increased risk for surgery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carotid Artery Disease
Intervention  ICMJE
  • Device: Cordis Nitinol Stent
  • Device: PRECISE tapered stent
  • Device: ANGIOGUARD XP Emboli Capture Guidewire (ECGW)
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: October 3, 2005)
1300
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The patient must be > 18 years of age.
  2. The patient has a 50% stenosis (as determined by ultrasound or angiogram) of the common or internal carotid artery and is clinically symptomatic; i.e., within the previous 180 days has experienced symptoms in the ipsilateral carotid artery distribution, defined as:

    • one or more TIAs, characterized by distinct focal neurologic dysfunction or monocular blindness with clearing of signs and symptoms within 24 hours, or
    • one or more completed strokes (as defined by this protocol) with persistence of symptoms or signs for more than 24 hours (the most recent event is used as the qualifying event), except as excluded below, with stenosis >50%, (as determined by ultrasound or angiogram) of the common or internal carotid artery, OR The patient must have a >80% diameter stenosis (as determined by ultrasound or angiogram) of the internal or common carotid artery without neurological symptoms.
  3. To be entered into the study, the patient must have one or more of the following conditions:

    • congestive heart failure (class III/IV) and/or known severe left ventricular dysfunction LVEF < 30%
    • open heart surgery within six weeks
    • recent MI (>24 hours and <4 weeks)
    • unstable angina (CCS class III/IV)
    • synchronous severe cardiac and carotid disease requiring open heart surgery and carotid revascularization
    • Age greater than 80 years as a single risk factor.

Exclusion Criteria:

  1. The patient is experiencing an acute ischemic neurologic stroke or has experienced a stroke within the past 48 hours.
  2. The patient has an intracranial mass lesion (i.e., abscess, tumor, or infection).
  3. The reference segment diameter (distal common carotid and internal carotid artery segment cephalic to the lesion) is less than 4mm or greater than 9mm by quantitative analysis. See Instructions For Use, for proper stent sizing. The exception to this would be with a lesion having >95% stenosis where the true diameter of the distal vessel can not be determined such as the case with a string sign or distal vessel collapse. In this case the judgment of the interventionalist will prevail with the intention not to oversize the stent to the distal vessel by more than 2mm.
  4. The patient has known peripheral vascular, supra-aortic or internal carotid artery tortuosity which preclude the use of catheter-based techniques if so randomized.
  5. The patient has any intracranial aneurysm (> 9 mm).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00231270
Other Study ID Numbers  ICMJE P98-5201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Cordis Corporation
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cordis Corporation
Verification Date July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP