- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00714623
The SCRIPPS DES REAL WORLD Registry
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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California
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La Jolla, California, Forenede Stater, 92037
- Scripps Green Hospital/Scripps Clinic Torrey Pines
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
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.
Tidsramme: 1 year
|
1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Paul S Teirstein, MD, Scripps Clinic
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Hjertesygdomme
- Hjerte-kar-sygdomme
- Karsygdomme
- Åreforkalkning
- Arterielle okklusive sygdomme
- Embolisme og trombose
- Koronar stenose
- Koronararteriesygdom
- Myokardieiskæmi
- Koronar sygdom
- Trombose
- Koronar restenose
- Koronar trombose
- Lægemidlers fysiologiske virkninger
- Anti-infektionsmidler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antibakterielle midler
- Antibiotika, antineoplastisk
- Antifungale midler
- Sirolimus
Andre undersøgelses-id-numre
- 04-048
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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