Contact information
Type
Scientific
Primary contact
Prof M.J. Schalij
ORCID ID
Contact details
Leiden University Medical Center
Department of Cardiology
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 5264811
m.j.schalij@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR396
Study information
Scientific title
Acronym
MISSION! Intervention Study
Study hypothesis
Thin strut cobalt chromium stents are not inferior in preventing restenosis compared to sirolimus-eluting stents in patients with acute myocardial infarction.
Ethics approval
Received from local medical ethics committee
Study design
Randomised open label controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Acute myocardial infarction
Intervention
The MISSION! Intervention Study is a prospective randomised study comparing non-coated, thin strut, cobalt chromium stents (Vision™) and sirolimus eluting stents (Cypher™) for the treatment of patients with acute myocardial infarction.
300 patients will be randomised 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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
In-lesion late loss at 9 months
Secondary outcome measures
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
Overall trial start date
01/02/2004
Overall trial end date
31/01/2006
Reason abandoned
Eligibility
Participant 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 length ≤ 24 mm
6. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant 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. 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
Recruitment start date
01/02/2004
Recruitment end date
31/01/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Center
Leiden
2300 RC
Netherlands
Funders
Funder type
Charity
Funder name
Dutch Heart Foundation (Nederlandse Hartstichting [NHS]) (Netherlands)
Alternative name(s)
Dutch Heart Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Netherlands
Funder name
Guidant Inc. (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19463300
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/20142177
Publication citations
-
Results
van der Hoeven BL, Liem SS, Dijkstra J, Bergheanu SC, Putter H, Antoni ML, Atsma DE, Bootsma M, Zeppenfeld K, Jukema JW, Schalij MJ, Stent malapposition after sirolimus-eluting and bare-metal stent implantation in patients with ST-segment elevation myocardial infarction: acute and 9-month intravascular ultrasound results of the MISSION! intervention study., JACC Cardiovasc Interv, 2008, 1, 2, 192-201, doi: 10.1016/j.jcin.2008.02.003.
-
Results
Atary JZ, Bergheanu SC, van der Hoeven BL, Atsma DE, Bootsma M, van der Kley F, Zeppenfeld K, Jukema JW, Schalij MJ, Impact of sirolimus-eluting stent implantation compared to bare-metal stent implantation for acute myocardial infarction on coronary plaque composition at nine months follow-up: a Virtual Histology intravascular ultrasound analysis. Results from the Leiden MISSION! intervention study., EuroIntervention, 2009, 5, 5, 565-572.