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.
ID
Bron
Verkorte titel
Aandoening
Patients with coronary artery disease undergoing percutaneous coronary intervention
Ondersteuning
Cardiologie poli 67
Henri Dunantweg 2
8934 AD Leeuwarden
The Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Clinical MACE at 1 year (cardiac mortality, non-fatal myocardial infarction, TVR).
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
18 months enrolment, and 36 month follow up.
Onderzoeksproduct en/of interventie
PCI with stent placement.
Publiek
Henri Dunantweg 2
A.J. Boven, van
Leeuwarden 8934 AD
The Netherlands
+31 (0)58 2866666
a.j.boven@znb.nl
Wetenschappelijk
Henri Dunantweg 2
A.J. Boven, van
Leeuwarden 8934 AD
The Netherlands
+31 (0)58 2866666
a.j.boven@znb.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3022 |
| NTR-old | NTR3170 |
| Ander register | METC : RTPO486a |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |