No registrations found.
ID
Source
Brief title
Health condition
Patients with coronary artery disease undergoing percutaneous coronary intervention
Sponsors and support
Cardiologie poli 67
Henri Dunantweg 2
8934 AD Leeuwarden
The Netherlands
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 years (cardiac death, non-fatal MI, TVR);
3. All cause mortality at 1, 2 and 3 year.
Background summary
This is a prospective randomized study designed to compare the effectiveness and safety, defined as clinical MACE at 12 months follow up, of the Xience V stent with the Cypher stent in all patients treated with PCI in the MCL. In order to study the long-term safety of the both DES, follow-up is planned for 3 years.
Study objective
To assess the effectiveness of the Xience stent compared to the CYPHER stent in the PCI treatment of all patients in the MCL during 2007- 2008. This study runs parallel with the XAMI study.
Study design
18 months enrolment, and 36 month follow up.
Intervention
PCI with stent placement.
Henri Dunantweg 2
A.J. Boven, van
Leeuwarden 8934 AD
The Netherlands
+31 (0)58 2866666
a.j.boven@znb.nl
Henri Dunantweg 2
A.J. Boven, van
Leeuwarden 8934 AD
The Netherlands
+31 (0)58 2866666
a.j.boven@znb.nl
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
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
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 | NL3022 |
| NTR-old | NTR3170 |
| Other | METC : RTPO486a |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |