The SCRIPPS DES REAL WORLD Registry

December 20, 2012 updated by: Paul S Teirstein, MD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

859

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Scripps Green Hospital/Scripps Clinic Torrey Pines

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients 18 years of age or older undergoing PCI and requiring the placement of at least one drug-eluting stent will be included to this study. For this registry, consecutive patients, that will have coronary percutaneous intervention with the CypherTM at the Green Hospital of Scripps Clinic, will be enrolled. It is estimated that up to 1000 patients will be included in the registry enrolled over a four year period. It is expected that enrollment will conclude in March 2009.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paul S Teirstein, MD

Collaborators

Cordis Corporation

Investigators

  • Principal Investigator: Paul S Teirstein, MD, Scripps Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

July 9, 2008

First Submitted That Met QC Criteria

July 11, 2008

First Posted (Estimate)

July 14, 2008

Study Record Updates

Last Update Posted (Estimate)

December 24, 2012

Last Update Submitted That Met QC Criteria

December 20, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-048

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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