Condition category
Circulatory System
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
13/08/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Leiden University Medical Centre, Department of Cardiology (Netherlands)

Sponsor details

P.O. Box 9600
Leiden
2300 RC
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

  1. 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.

  2. 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.

Additional files

Editorial Notes