No registrations found.
ID
Source
Brief title
Health condition
1. Acute myocardial infarction;
2. drug-eluting stent.
Sponsors and support
Medisch centrum Leeuwarden
cardiologie poli 67
Henri Dunantweg 2
8934 AD Leeuwarden
The Netherlands
shhofma@hetnet.nl
+31-58 2867766
Cordis NL (non restricted grand).
Intervention
Outcome measures
Primary outcome
Clinical MACE at 1 year (cardiac mortality, non-fatal myocardial infarction, TVR.
Secondary outcome
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.
Background summary
This is a prospective randomized multi-center study designed to assess clinical performance of the Xience stent in AMI patients compaired to the CYPHER.
The patient will undergo a clinical examination to assess their clinival status and the occurrence of adevrse clinical events before and after the procedure and follow-up at 30 days, 1, 2 and 3 years after the procedure.
Study objective
Essess the effectiveness of the Xience stent compared to the CYPHHER stent in the treatment of acute myocardial infarction patients.
Study design
18 month enrolment and 36 month follow-up.
Intervention
PCI with stent placement.
Dokter Stolteweg 96
J. Klijn
Dokter Stolteweg 96
Zwolle 8025 AZ
The Netherlands
+31 (0)38 4262997
j.klijn@diagram-zwolle.nl
Dokter Stolteweg 96
J. Klijn
Dokter Stolteweg 96
Zwolle 8025 AZ
The Netherlands
+31 (0)38 4262997
j.klijn@diagram-zwolle.nl
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
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 < 1 year;
10. stent size >3.5 mm required to treat lesion.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1090 |
| NTR-old | NTR1123 |
| Other | XAMI : ABR NL17690.0099.07 Diagr. 9056 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |