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Carotid Artery DiseasePhase 3NCT00231270

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

A Phase 3 study testing Cordis Nitinol Stent, PRECISE tapered stent and ANGIOGUARD XP Emboli Capture Guidewire (ECGW) in people with Carotid Artery Disease, run by Cordis US Corp..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Carotid Artery Disease
What is being tested?
Cordis Nitinol Stent, PRECISE tapered stent and ANGIOGUARD XP Emboli Capture Guidewire (ECGW)
Type of treatment
Medical device
How many people
1,300 participants
Where
No sites listed yet
Study dates
Aug 2000to Aug 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%
Show all 11Show fewer
  • 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.

Who cannot join

  • 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).

About this study

Official title: Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy

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.

Being tested
Cordis Nitinol Stent, PRECISE tapered stent, ANGIOGUARD XP Emboli Capture Guidewire (ECGW)
Medical subject headings
Carotid Artery Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cordis Nitinol StentDevice

  • PRECISE tapered stentDevice

  • ANGIOGUARD XP Emboli Capture Guidewire (ECGW)Device

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 30-days post-procedure

  2. The same 30-day composite of major adverse clinical events plus death and/or ipsilateral stroke between 31-days and 12-months post-procedure.

    Measured: Between day 31 and 12-months post-procedure.

Secondary outcomes (12)

  1. successful stent deployment at the target lesion in a variety of carotid morphologies

  2. successful filter deployment and retrieval

  3. <30% residual stenosis determined by angiography immediately post-stent placement and post-dilatation

  4. endovascular access site complications, such as the need for surgical repair or blood transfusion

  5. surgical site complications, such as wound infection or hematoma, that prolong hospital stay, require incision and drainage, or need blood transfusion

  6. 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

  7. 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

  8. thirty (30)-day and six (6)-month evaluation for disabling stroke

    Measured: Day 30 and 6 months

  9. six (6)-month, one (1)-year, two (2)-year and three (3)-year composite of major adverse clinical events including death and ipsilateral stroke

    Measured: 6 month and 1, 2, 3yr

  10. safety assessment of the ANGIOGUARD XP Emboli Capture Guidewire Device

  11. 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

  12. laboratory analysis of trapped material contained in the ANGIOGUARD XP filter basket

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2005 (estimated)
  2. Study startAug 2000
  3. Study completionAug 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,300 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00231270
Sponsor's protocol ID
P98-5201
Status last verified
Jul 2007
First submitted
3 Oct 2005
Last updated
24 Apr 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 15470212

  • 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.

    PubMed 18403765

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cordis Nitinol Stent, PRECISE tapered stent and ANGIOGUARD XP Emboli Capture Guidewire (ECGW) in people with Carotid Artery Disease, run by Cordis US Corp..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00231270, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2008.

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