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 |
| Protocol serial number | NTR396 |
| Sponsor | Leiden University Medical Centre, Department of Cardiology (Netherlands) |
| Funders | Dutch Heart Foundation (Nederlandse Hartstichting [NHS]) (Netherlands), Guidant Inc. (USA) |
- 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
Scientific
Leiden University Medical Center
Department of Cardiology
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 5264811 |
|---|---|
| m.j.schalij@lumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised open label controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | MISSION! Intervention Study |
| Study objectives | Thin 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) studied | 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 |
| Primary outcome measure(s) |
In-lesion late loss at 9 months |
| Key secondary outcome measure(s) |
1. MACE (death, myocardial infarction, target vessel revascularisation, target lesion revascularisation) at 12 months |
| Completion date | 31/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 300 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2004 |
| Date of final enrolment | 31/01/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Center
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
