The SCRIPPS DES REAL WORLD Registry

This study is a prospective, non-randomized, open-label registry of consecutive patients with CAD treated by stent-assisted PCI using at least one CypherTM stent. Up to 1000 pts will be included in the registry. The registry is conducted for the evaluation of the impact of CypherTM Sirolimus-eluting stent implantation in the "real world" of interventional cardiology. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study specific procedures. Consecutive patients treated with the use of the CypherTM stent will be included in the registry. Baseline and post-procedure blood samples will be used to perform platelet function analysis using the Accumetrics Ultegra RPFA (Rapid Platelet Function Assay).

All patients will be followed from enrollment through the hospital discharge for any clinically significant event (death, myocardial infarction, TLR, TVR, major or minor bleeding). A follow-up telephone assessment of death, myocardial infarction, revascularization, and medical treatment will be conducted by experienced research personnel at 30 days, 6 months, 1 year and at least 2 years. All site reported deaths, myocardial infarctions and revascularizations will be adjudicated by an independent Clinical Events Committee for all 1000 patients enrolled in the trial. An interim analysis of the first 750 patients will be conducted and data forwarded to FDA.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Coronary Restenosis Coronary Stenosis Coronary Thrombosis Embolism and Thrombosis Heart Diseases Myocardial Ischemia Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Green Hospital/Scripps Clinic Torrey Pines

La Jolla, California, 92037, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Age 18 years or older
Eligible for percutaneous coronary intervention
Patient has at least one lesion ≥50% diameter stenosis requiring PCI with stenting
Reference vessel diameter 2.25-4.0 mm
Percutaneous intervention with use of one or more of the FDA approved CypherTM stents, planned not to exceed 108 mm of stent length.
Target lesion is located within a native coronary artery or bypass graft
De novo and restenotic lesions, including ISR, radiation failure
Be reliable, cooperative and willing to comply with all protocol-specified procedures and follow-up
Able to understand and grant informed consent

Exclusion criteria

Confirmed pregnancy at the time of index PCI
Has known allergies to aspirin, and to both clopidogrel (PlavixTM) and ticlopidine (TiclidTM)
Has known allergies or contraindication to heparin and Bivalirudin (AngiomaxTM)
Known allergy or sensitivity to any component of a Sirolimus-eluting stent
Has a significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study;
Any serious disease condition with life expectancy of less than 1 year.

Treatment and study plan

Sirolimus-Eluting Bx Velocity Coronary Stent (CypherTM Sirolimus-Eluting Stent)

Device

Indications for use: The CYPHER™ Sirolimus-eluting Coronary Stent is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length less than or equal to 30 mm in native coronary arteries with a reference vessel diameter between 2.5 and 3.5 mm. Long-term outcome (beyond 12 months) for this permanent implant is unknown at present.

Other names: CYPHER™ Stent

Primary outcomes

1 yr target vessel failure (TVF), defined as the occurrence of any of the following within 1-year after the index procedure: death from cardiac causes, Q-wave or non-Q wave MI attributable to the target vessel (TV), or revascularization of the TV.

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Paul S Teirstein, MD

Other

Collaborators

Cordis US Corp.

Registry information

Official study title

A Prospective Registry for the Use of CypherTM Sirolimus-Eluting Stents In Patients With Coronary Artery Disease Treated With Percutaneous Coronary Interventions at Scripps Clinic

Important dates

Study start: 2005
Primary completion: 2012
Study completion: 2012
First posted: Jul 14, 2008
Registry last updated: Dec 24, 2012

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.

Published trials that share one or more normalized conditions with this study.

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