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

NCT ID: NCT00231270

Last Updated: 2008-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-08-31
• Study Completion Date: 2005-08-31

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.

Conditions

Carotid Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Cordis Nitinol Stent

Intervention Type: DEVICE

PRECISE tapered stent

Intervention Type: DEVICE

ANGIOGUARD XP Emboli Capture Guidewire (ECGW)

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cordis Corporation

INDUSTRY

Sponsor Role: lead

References

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.

Reference Type: RESULT

PMID: 15470212 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18403765 (View on PubMed)

Other Identifiers

P98-5201

Identifier Type: -

Identifier Source: org_study_id