The MISSION! Intervention Study: A Prospective Randomised Controlled Trial to Evaluate the Efficacy of Drug-Eluting Stents versus Bare-Metal Stents for the Treatment of Acute Myocardial Infarction

ISRCTN ISRCTN62825862
DOI https://doi.org/10.1186/ISRCTN62825862
Secondary identifying numbers NTR396
Submission date
27/01/2006
Registration date
27/01/2006
Last edited
13/08/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof M.J. Schalij
Scientific

Leiden University Medical Center
Department of Cardiology
P.O. Box 9600
Leiden
2300 RC
Netherlands

Phone +31 (0)71 5264811
Email m.j.schalij@lumc.nl

Study information

Study designRandomised open label controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymMISSION! Intervention Study
Study objectivesThin strut cobalt chromium stents are not inferior in preventing restenosis compared to sirolimus-eluting stents in patients with acute myocardial infarction.
Ethics approval(s)Received from local medical ethics committee
Health condition(s) or problem(s) studiedAcute myocardial infarction
InterventionThe 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 typeOther
Primary outcome measureIn-lesion late loss at 9 months
Secondary outcome measures1. 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 study start date01/02/2004
Completion date31/01/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants300
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/02/2004
Date of final enrolment31/01/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Leiden University Medical Center
Leiden
2300 RC
Netherlands

Sponsor information

Leiden University Medical Centre, Department of Cardiology (Netherlands)
Hospital/treatment centre

P.O. Box 9600
Leiden
2300 RC
Netherlands

ROR logo "ROR" https://ror.org/027bh9e22

Funders

Funder type

Charity

Dutch Heart Foundation (Nederlandse Hartstichting [NHS]) (Netherlands)
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Heart Foundation
Location
Netherlands
Guidant Inc. (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2008 Yes No
Results article results 01/11/2009 Yes No