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Cypher drug-Eluting stent: a Zwolle Acute myocardial infarction Randomised trial

Cypher drug-Eluting stent: a Zwolle Acute myocardial infarction Randomised trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN90526229
Enrollment
352
Registered
2005-09-12
Start date
2004-06-01
Completion date
Unknown
Last updated
2021-08-30

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

Conditions

Acute myocardial infarction Circulatory System Infarction

Interventions

Percutaneous Coronary Intervention using either the Bx VELOCITYTM stent coated with rapamycin (Cypher) or the TaxusTM stent coated with Paclitaxel.

Sponsors

Isala klinieken (The Netherlands)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with acute myocardial infarction, presenting within six hours after symptom-onset, or those presenting between six and 24 hours if persisting chest pain associated with clinical evidence of on-going ischaemia occurs 2. Culprit lesion in a native coronary artery, suitable for stenting 3. Lesion length of less than 30 mm, located in a vessel of more than 2.5 mm 4. Able to deliver the stent to target lesion (absence of diffuse disease or excessive proximal vessel tortuosity) 5. Absence of no-reflow or extensive thrombus throughout vessel

Exclusion criteria

Exclusion criteria: 1. Women of child-bearing potential 2. Severe hepatic or renal disease 3. Previous participation in the study 4. Life expectancy of less than one year 5. Factors making follow-up difficult 6. Acute myocardial infarction pre-treated with thrombolysis 7. Unprotected left main disease or single remaining vessel 8. Target lesion in a bifurcation with a large side-branch 9. Known sensitivity to aspirin or coumarin 10. Unable to provide informed consent

Design outcomes

Primary

MeasureTime frame
Major adverse cardiac clinical events (death, re-infarction, target vessel revascularisation) at one, nine and 12 months after treatment.

Secondary

MeasureTime frame
Late lumen loss at nine months follow-up by quantitative coronary angiography

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026