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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26637
Enrollment
2000
Registered
2011-12-01
Start date
2007-12-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with coronary artery disease undergoing percutaneous coronary intervention

Interventions

Sponsors

Medisch Centrum Leeuwarden, Cardiologie poli 67 Henri Dunantweg 2 8934 AD Leeuwarden The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

MeasureTime frame
Clinical MACE at 1 year (cardiac mortality, non-fatal myocardial infarction, TVR).

Secondary

MeasureTime frame
1. (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.

Contacts

Public ContactA.J. Boven, van

Afd. Cardiologie Henri Dunantweg 2

a.j.boven@znb.nl+31 (0)58 2866666

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)