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

Primary Purpose

Carotid Artery Disease

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Cordis Nitinol Stent
PRECISE tapered stent
ANGIOGUARD XP Emboli Capture Guidewire (ECGW)
Sponsored by
Cordis Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Artery Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The patient must be > 18 years of age. 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. 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: The patient is experiencing an acute ischemic neurologic stroke or has experienced a stroke within the past 48 hours. The patient has an intracranial mass lesion (i.e., abscess, tumor, or infection). 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. The patient has known peripheral vascular, supra-aortic or internal carotid artery tortuosity which preclude the use of catheter-based techniques if so randomized. The patient has any intracranial aneurysm (> 9 mm).

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    October 3, 2005
    Last Updated
    April 17, 2008
    Sponsor
    Cordis Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00231270
    Brief Title
    Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy (SAPPHIRE)
    Official Title
    Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2000 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Cordis Corporation

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carotid Artery Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1300 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Cordis Nitinol Stent
    Intervention Type
    Device
    Intervention Name(s)
    PRECISE tapered stent
    Intervention Type
    Device
    Intervention Name(s)
    ANGIOGUARD XP Emboli Capture Guidewire (ECGW)
    Primary Outcome Measure Information:
    Title
    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
    Title
    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.
    Secondary Outcome Measure Information:
    Title
    successful stent deployment at the target lesion in a variety of carotid morphologies
    Title
    successful filter deployment and retrieval
    Title
    <30% residual stenosis determined by angiography immediately post-stent placement and post-dilatation
    Title
    endovascular access site complications, such as the need for surgical repair or blood transfusion
    Title
    surgical site complications, such as wound infection or hematoma, that prolong hospital stay, require incision and drainage, or need blood transfusion
    Title
    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
    Title
    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
    Title
    thirty (30)-day and six (6)-month evaluation for disabling stroke
    Time Frame
    Day 30 and 6 months
    Title
    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
    Title
    safety assessment of the ANGIOGUARD XP Emboli Capture Guidewire Device
    Title
    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
    Title
    laboratory analysis of trapped material contained in the ANGIOGUARD XP filter basket

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The patient must be > 18 years of age. 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. 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: The patient is experiencing an acute ischemic neurologic stroke or has experienced a stroke within the past 48 hours. The patient has an intracranial mass lesion (i.e., abscess, tumor, or infection). 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. The patient has known peripheral vascular, supra-aortic or internal carotid artery tortuosity which preclude the use of catheter-based techniques if so randomized. The patient has any intracranial aneurysm (> 9 mm).

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15470212
    Citation
    Yadav JS, Wholey MH, Kuntz RE, Fayad P, Katzen BT, Mishkel GJ, Bajwa TK, Whitlow P, Strickman NE, Jaff MR, Popma JJ, Snead DB, Cutlip DE, Firth BG, Ouriel K; Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy Investigators. Protected carotid-artery stenting versus endarterectomy in high-risk patients. N Engl J Med. 2004 Oct 7;351(15):1493-501. doi: 10.1056/NEJMoa040127.
    Results Reference
    result
    PubMed Identifier
    18403765
    Citation
    Gurm HS, Yadav JS, Fayad P, Katzen BT, Mishkel GJ, Bajwa TK, Ansel G, Strickman NE, Wang H, Cohen SA, Massaro JM, Cutlip DE; SAPPHIRE Investigators. Long-term results of carotid stenting versus endarterectomy in high-risk patients. N Engl J Med. 2008 Apr 10;358(15):1572-9. doi: 10.1056/NEJMoa0708028.
    Results Reference
    result

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

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