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XienceV stent vs Cypher stent in primary PCI for acute myocardial infarction.

XienceV stent vs Cypher stent in primary PCI for acute myocardial infarction; a randomized trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27542
Enrollment
800
Registered
2007-11-09
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

1. Acute myocardial infarction

Interventions

Sponsors

Dr. S.H. Hofma Medisch centrum Leeuwarden cardiologie poli 67 Henri Dunantweg 2 8934 AD Leeuwarden The Netherlands shhofma@hetnet.nl +31-58 2867766
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with acute ST elevated myocardial infarction; 2. Patient is willing to perform all follow-up examination as required by the protocol; 3. Patient is eligible for coronary revascularization intervention by PCI and stenting; 4. Patient is located in a geographic area that will enable contact by study site follow-up.

Exclusion criteria

Exclusion criteria: 1. Chronical total occlusion as target lesion intervention; 2. stent thrombosis or previous stent at target lesion; 3. drug,-alcohol abusers or prisoners; 4. allergic to everolimus or sirolimus; 5. intolerance or contra-indicated to treatment with acetylsalicylic acid or clopidogrel; 6. over 80 years old; 7. stent implantation not possible, judged by cardiologist; 8. intubated patients; 9. life expectancy 3.5 mm required to treat lesion.

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 year (cardiac death, non fatal MI, TVR); 3. All cause mortality at 1,2 and 3 year.

Contacts

Public ContactJ. Klijn

Diagram B.V. Zwolle Dokter Stolteweg 96

j.klijn@diagram-zwolle.nl+31 (0)38 4262997

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)