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ISRCTN
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ISRCTN62825862
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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MISSION! Intervention Study
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Serial number at source
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N/A
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Study hypothesis
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Thin strut cobalt chromium stents are not inferior in preventing restenosis compared to sirolimus-eluting stents in patients with acute myocardial infarction.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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The Netherlands
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Disease/condition/study domain
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Acute myocardial infarction
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Participants - inclusion criteria
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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 length </=24 mm
6. Written informed consent
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Participants - exclusion criteria
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1. Rescue PTCA
2. Start symptoms >9 hours before the procedure
3. Left main lesion with >/= 50% diameter stenosis
4. Triple vessel disease
5. Involvement 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
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Anticipated start date
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01/02/2004
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Anticipated end date
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31/01/2006
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Status of trial
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Completed
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Patient information material
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Target number of participants
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300
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Interventions
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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.
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Primary outcome measure(s)
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In-lesion late loss at 9 months
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Secondary outcome measure(s)
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1. MACE (death, myocardial infarction, target vessel revascularisation, target lesion revascularisation) at 12 months
2. Incomplete stent apposition at 9 months
3. Minimal lumen area at 9 months
4. Fractional flow reserve at 9 months
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Sources of funding
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Dutch Heart Foundation, Guidant Inc
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Trial website
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Publications
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Contact name
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Prof
M.J.
Schalij
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Address
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Leiden University Medical Center
Department of Cardiology
P.O. Box 9600
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City/town
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Leiden
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Zip/Postcode
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2300 RC
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Country
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Netherlands
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Tel
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+31 (0)71 5264811
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Fax
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+31 (0)71 5266809
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Email
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m.j.schalij@lumc.nl
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Sponsor
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Leiden University Medical Center, Department of Cardiology (The Netherlands)
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Address
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P.O. Box 9600
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City/town
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Leiden
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Zip/Postcode
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2300 RC
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Country
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Netherlands
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Date applied
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27/01/2006
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Last edited
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31/01/2006
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Date ISRCTN assigned
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27/01/2006
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