search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


MISSION! Intervention Study.


- candidate number1636
- NTR NumberNTR396
- ISRCTNISRCTN62825862
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR13-sep-2005
- Secondary IDsN/A 
- Public TitleMISSION! Intervention Study.
- Scientific TitleThe 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.
- ACRONYMMISSION! Intervention Study
- hypothesisThin 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) studiedAcute myocardial infarction
- 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 lenth <=24 mm;
6. Written informed consent.
- 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. 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2004
- planned closingdate31-jan-2006
- Target number of participants300
- Interventions1. Percutaneous Coronary Intervention;
2. Intravascular Ultrasound;
3. Fractional Flow Reserve.
- Primary outcomeIn-lesion late loss at 9 months.
- Secondary outcome1. 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.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. Dr. M.J. Schalij
- CONTACT for SCIENTIFIC QUERIESProf. Dr. M.J. Schalij
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Cardiology
- Funding
(Source(s) of Monetary or Material Support)
Dutch Heart Foundation (Nederlandse Hartstichting), Guidant Inc
- PublicationsN/A
- Brief summaryThe 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)
- RECORD13-sep-2005 - 29-okt-2008


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl