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Completed

NCT Number: NCT00403078

SAPPHIRE Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy

The primary objective of this study is to assess the outcomes of stenting with distal protection in the treatment of obstructive carotid artery disease. The devices to be utilized are the Cordis PRECISE® Nitinol Stent Systems (5.5F and 6F) and the Cordis ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW).

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Key information

Conditions

Carotid Artery Disease Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Christiana Care Health Services, Newark, Delaware, United States

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About this study

Carotid Artery Stenting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • High-surgical risk patients to be treated consistent with IFU labeling
  • The patient or legally authorized representative has signed a written informed consent and HIPAA authorization, prior to the procedure, using a form that is approved by the Institutional Review Board or Medical Ethics Committee.

Exclusion criteria

  • Patients not treated per the IFU
  • Patients who are contraindicated per the IFU
  • Patients previously enrolled in the study
  • Patients requiring stenting of in-stent restenosis after CAS
  • Inability or refusal to provide informed consent.

Treatment and study plan

Primary outcomes

  1. Any death, stroke or any MI

    Time frame: up to 30-days post-procedure

Secondary outcomes

  1. Assess the consistency of MAE rates of stenting with distal protection in the treatment of obstructive carotid artery disease among high, medium and low volume centers with physicians who have validated CASES training levels of 1, 2, 2P or 3

    Time frame: 30 days

  2. Assess the real-world cost-effectiveness of carotid artery stenting in subjects enrolled

    Time frame: Every follow-up where a PRO instrument QoL was assessed

  3. Estimate MAE (death and ipsilateral stroke) rate in a subset of the planned total enrollment

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Cordis US Corp.

Industry

Registry information

Official study title

Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy (SAPPHIRE Worldwide)

Important dates

Study start
2006
Primary completion
2014
Study completion
2014
First posted
Nov 23, 2006
Registry last updated
Aug 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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