The SCRIPPS DES REAL WORLD Registry

NCT ID: NCT00714623

Last Updated: 2012-12-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 859 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2012-04-30

Brief Summary

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.

Conditions

Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis

Keywords

Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Angioplasty, Transluminal, Percutaneous Coronary

Study Design

• Study Time Perspective: PROSPECTIVE

Interventions

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

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.

Intervention Type: DEVICE

Other Intervention Names

CYPHER™ Stent

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cordis Corporation

INDUSTRY

Sponsor Role: collaborator

Paul S Teirstein, MD

OTHER

Sponsor Role: lead

Responsible Party

Paul S Teirstein, MD

Chief of Cardiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Paul S Teirstein, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Clinic

Locations

Scripps Green Hospital/Scripps Clinic Torrey Pines

La Jolla, California, United States

Countries

United States

Other Identifiers

04-048

Identifier Type: -

Identifier Source: org_study_id