Skip to content

Cypher drug-Eluting stent: A Zwolle AMI Randomized trial.

Comparative Randomized Trial of Rapamycin versus Paclitaxel-eluting stent in AMI.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28019
Enrollment
352
Registered
2005-08-04
Start date
2004-06-01
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

acute myocardial infarction, scheduled for emergency coronary angioplasty

Interventions

Percutane Coronaire Interventie.

Sponsors

Dr Harry Suryapranata Dr Giuseppe De Luca Department of Cardiology ISALA Klinieken Hospital De Weezenlanden Zwolle, The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with acute myocardial infarction, presenting within 6 hours after symptom-onset, or those presenting between 6 and 24 hours if persisting chest pain associated with clinical evidence of on-going ischemia occurs; 2. Culprit lesion in a native coronary artery, suitable for stenting; 3. Lesion length of 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 < 1 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 revascularization) at 1, 9 and 12 months after treatment.

Secondary

MeasureTime frame
Late lumen loss at 9 months follow-up by quantitative coronary angiography.

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)