Thin strut cobalt chromium stents are not inferior in preventing restenosis compared to sirolimus-eluting stents in patients with acute myocardial infarction.
ID
Bron
Verkorte titel
Aandoening
Acute myocardial infarction.
Ondersteuning
Department of Cardiology
Albinusdreef 2
2300 RC Leiden
Guidant Inc
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
In-lesion late loss at 9 months.
Achtergrond van het onderzoek
The MISSION! Intervention Study is a prospective randomized study comparing non-coated, thin strut, cobalt chromium stents (Vision TM) and sirolimus eluting stents (Cypher TM) for the treatment of patients with acute myocardial infarction.
300 patients will be randomized and treated by primary percutaneous coronary intervention with stent implantation. All patients will have angiographic follow-up at 9 months to assess the primary endpoint with Quantitative Coronary Angiography. In all patients, IVUS will be performed post-intervention and at 9 months follow-up to assess acute and late incomplete stent apposition and neointimal volume.
Moreover fractional flow reserve will be measured at 9 months to assess functional stent patency. At 12 months major adverse events will be counted and analysed according to life table methods.
Clinical and angiographic data will be analyzed according to the principle of intention-to-treat and evaluable group analyses. End-point variables will be presented by means of 95% confidence intervals.
Doel van het onderzoek
Thin strut cobalt chromium stents are not inferior in preventing restenosis compared to sirolimus-eluting stents in patients with acute myocardial infarction.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
1. Percutaneous Coronary Intervention;
2. Intravascular Ultrasound;
3. Fractional Flow Reserve.
Publiek
Department of Cardiology,
P.O. Box 9600
M.J. Schalij
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5264811
m.j.schalij@lumc.nl
Wetenschappelijk
Department of Cardiology,
P.O. Box 9600
M.J. Schalij
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5264811
m.j.schalij@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Between 18 and 80 years of age;
2. ECG evidence of an acute myocardial infarction;
3. De novo native culprit lesion;
4. Target vessel with a reference diameter between 2.25 and 3.75 mm;
5. Target lesion lenth <=24 mm;
6. Written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Rescue PTCA;
2. Start symptoms >9 hours before the procedure;
3. Left main lesion with >=50% diameter stenosis;
4. Triple vessel disease;
5. Involvment of a major side branch;
6. Previous PCI or CABG of the culprit vessel;
7. Renal insufficiency;
8. Unwilling or unable to comply with the study requirements or follow-up evaluations;
9. Contraindication for abciximab;
10. Extensive peripheral vascular disease;
11. Non-cardiac illness with a life expectancy less than 12 months.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL357 |
| NTR-old | NTR396 |
| Ander register | : N/A |
| ISRCTN | ISRCTN62825862 |