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

NCT00231270 | Completed Phase 3 DMC

• 1 other identifier: P98-5201
• Study Type: interventional
• Target: 1,300
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• composite of major adverse clinical events including death, any stroke, and/or myocardial infarction at 30-days post-procedure

  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.

  Between day 31 and 12-months post-procedure.

Secondary Outcomes (12)

• 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

Interventions

Cordis Nitinol Stent DEVICE

PRECISE tapered stent DEVICE

ANGIOGUARD XP Emboli Capture Guidewire (ECGW) DEVICE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cordis US Corp.: lead

Related Publications (2)

• 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.

  PMID: 15470212 RESULT

• 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.

  PMID: 18403765 RESULT

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 3, 2005
• First Posted: October 4, 2005
• Study Start: August 1, 2000
• Study Completion: August 1, 2005
• Last Updated: April 24, 2008

Record last verified: 2007-07