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Xience V stent vs. Cypher stent in all-comer patients: A randomized trial.


- candidate number10606
- NTR NumberNTR3170
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-dec-2011
- Secondary IDsRTPO486a METC
- Public TitleXience V stent vs. Cypher stent in all-comer patients: A randomized trial.
- Scientific TitleXience V stent vs. Cypher stent in all-comer patients: A randomized trial.
- ACRONYMAPPENDIX-AMI
- hypothesisTo assess the effectiveness of the Xience stent compared to the CYPHER stent in the PCI treatment of all patients in the MCL during 2007- 2008. This study runs parallel with the XAMI study.
- Healt Condition(s) or Problem(s) studiedPercutaneous Coronary Intervention (PCI), Coronary artery disease
- Inclusion criteria1. Patient is willing to sign the informed consent;
2. Patient is willing to perform all follow-up examinations as required by the protocol;
3. Patient eligible for coronary revascularization intervention by PCI and stenting;
4. Patient is located in a geographic area that will enable contact by the study site for follow-up.
- Exclusion criteria1. Patients who are minor, intravenous drug abusers, alcohol abuser, prisoners or unable to give informed consent;
2. Patients who are allergic to everolimus or sirolimus;
3. Patients with known intolerance or contra-indications to treatment with acetylsalicylic acid or clopidogrel;
4. Patients in whom the cardiologist judges that stent implantation is not possible, realistic or justified.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupFactorial
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2007
- planned closingdate1-jun-2012
- Target number of participants2000
- InterventionsPCI with stent placement.
- Primary outcomeClinical MACE at 1 year (cardiac mortality, non-fatal myocardial infarction, TVR).
- Secondary outcome1. (Sub)-acute stent thrombosis (SAT) at 30 days and late stent thrombosis (LST) at 1, 2 and 3 year;
2. Clinical MACE at 30 days and 2 and 3 years (cardiac death, non-fatal MI, TVR);
3. All cause mortality at 1, 2 and 3 year.
- Timepoints18 months enrolment, and 36 month follow up.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. PhD. A.J. Boven, van
- CONTACT for SCIENTIFIC QUERIESMD. PhD. A.J. Boven, van
- Sponsor/Initiator Medisch centrum Leeuwarden, cardiologie poli 67
- Funding
(Source(s) of Monetary or Material Support)
Medisch Centrum Leeuwarden
- PublicationsN/A
- Brief summaryThis is a prospective randomized study designed to compare the effectiveness and safety, defined as clinical MACE at 12 months follow up, of the Xience V stent with the Cypher stent in all patients treated with PCI in the MCL. In order to study the long-term safety of the both DES, follow-up is planned for 3 years.
- Main changes (audit trail)
- RECORD1-dec-2011 - 12-dec-2011


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