Long-term Comparison of Stenting Versus Off-pump Coronary Bypass Surgery
OCTOSTENT
A Randomized Comparison of Long-term Clinical , Neurocognitive, Angiographical and Health-costs, After Stenting Versus Off-pump Coronary Bypass Surgery in Patients With Symptomatic Coronary Artery Disease
1 other identifier
interventional
280
1 country
1
Brief Summary
The randomized comparison of two strategies in coronary revascularization: bypass surgery without the use of a heart lung machine and coronary stenting procedure. The comparison comprised the occurrence of cardiac adverse events after the procedure. In addition, costs, cognitive outcomes and angiography were assessed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable coronary-artery-disease
Started Jan 1998
Typical duration for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1998
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 11, 2009
CompletedFirst Posted
Study publicly available on registry
September 14, 2009
CompletedSeptember 15, 2009
September 1, 2009
3 years
September 11, 2009
September 14, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major Adverse Cardiac Events
7.5 years
Secondary Outcomes (4)
Quality of Life
7.5 years
Neurocognitive outcome
7.5 years
Cost effectiveness
7.5 years
Angiographical patency of revascularization
7.5 years
Study Arms (2)
Percutaneous Coronary Intervention
ACTIVE COMPARATOROff Pump Coronary Artery Bypass Surgery
EXPERIMENTALInterventions
revascularization of coronary arteries in case of symptomatic obstructive coronary artery disease
Eligibility Criteria
You may qualify if:
- patients with coronary artery disease referred for PCI in which both Off Pump Coronary Bypass surgery and PCI were deemed technically feasible
You may not qualify if:
- a history of CABG or stenting
- emergency or concomitant major surgery
- Q-wave myocardial infarction in the last six weeks
- inability to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMC Utrechtlead
- St. Antonius Hospitalcollaborator
- Isalacollaborator
Study Sites (1)
UMC Utrecht
Utrecht, Netherlands
Related Publications (1)
Eefting F, Nathoe H, van Dijk D, Jansen E, Lahpor J, Stella P, Suyker W, Diephuis J, Suryapranata H, Ernst S, Borst C, Buskens E, Grobbee D, de Jaegere P. Randomized comparison between stenting and off-pump bypass surgery in patients referred for angioplasty. Circulation. 2003 Dec 9;108(23):2870-6. doi: 10.1161/01.CIR.0000100723.50363.2C. Epub 2003 Dec 1.
PMID: 14656913RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hendrik M Nathoe, MD PhD
UMC Utrecht
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 11, 2009
First Posted
September 14, 2009
Study Start
January 1, 1998
Primary Completion
January 1, 2001
Study Completion
February 1, 2001
Last Updated
September 15, 2009
Record last verified: 2009-09