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MISSION! Intervention Study.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28145
Enrollment
300
Registered
2005-09-13
Start date
2004-02-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myocardial infarction.

Interventions

1. Percutaneous Coronary Intervention
2. Intravascular Ultrasound
3. Fractional Flow Reserve.

Sponsors

Leiden University Medical Center Department of Cardiology Albinusdreef 2 2300 RC Leiden
Lead Sponsor

Eligibility

Inclusion criteria

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 lenth <=24 mm; 6. Written informed consent.

Exclusion criteria

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. 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.

Design outcomes

Primary

MeasureTime frame
In-lesion late loss at 9 months.

Secondary

MeasureTime frame
1. 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.

Contacts

Public ContactM.J. Schalij

Leiden University Medical Center (LUMC), Department of Cardiology, P.O. Box 9600

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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)