|- candidate number||1636|
|- NTR Number||NTR396|
|- Date ISRCTN created||27-jan-2006|
|- date ISRCTN requested||18-nov-2005|
|- Date Registered NTR||13-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||MISSION! Intervention Study.|
|- Scientific Title||The MISSION! Intervention Study: A Prospective Randomized Controlled Trial to Evaluate the Efficacy of Drug-Eluting Stents versus Bare-Metal Stents for the Treatment of Acute Myocardial Infarction.|
|- ACRONYM||MISSION! Intervention Study|
|- hypothesis||Thin strut cobalt chromium stents are not inferior in preventing restenosis compared to sirolimus-eluting stents in patients with acute myocardial infarction.|
|- Healt Condition(s) or Problem(s) studied||Acute myocardial infarction |
|- Inclusion criteria||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.
|- Exclusion criteria||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.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2004|
|- planned closingdate||31-jan-2006|
|- Target number of participants||300|
|- Interventions||1. Percutaneous Coronary Intervention;
2. Intravascular Ultrasound;
3. Fractional Flow Reserve.
|- Primary outcome||In-lesion late loss at 9 months.|
|- Secondary outcome||1. MACE (death, myocard infarction, target vessel revascularisation, target lesion revascularisation) at 12 months;|
2. Incomplete stent apposition at 9 months;
3. Minimal lumen areat at 9 months;
4. Fractional flow reserve at 9 months.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. M.J. Schalij|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. M.J. Schalij|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC), Department of Cardiology|
(Source(s) of Monetary or Material Support)
|Dutch Heart Foundation (Nederlandse Hartstichting), Guidant Inc|
|- Brief summary||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.
|- Main changes (audit trail)|
|- RECORD||13-sep-2005 - 29-okt-2008|