Coronary Artery DiseaseOCTOSTENTNCT00975858
Long-term Comparison of Stenting Versus Off-pump Coronary Bypass Surgery
A study testing Coronary Revascularization in people with Coronary Artery Disease, run by UMC Utrecht at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Coronary Revascularization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 1998to Feb 2001
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with coronary artery disease referred for PCI in which both Off Pump Coronary Bypass surgery and PCI were deemed technically feasible
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
Coronary artery bypass surgery with use of the heart lung machine (on-pump surgery), is associated with the risk of peri-operative complications such as death, stroke, myocardial infarction, neurocognitive decline, and extended hospitalization. Bypass surgery on the beating heart without the use of the heart lung machine (off-pump surgery) has been reintroduced in clinical practice in order to reduce these complications. The Octopus cardiac wall stabilizer, developed at the UMC Utrecht, facilitates the safe construction of the grafts during the off-pump procedure. The expected advantages of off-pump surgery e.g. less-invasiveness, complete arterial revascularization, faster recovery and lower costs were the basis for the Octostent trial. We hypothesized that the off-pump surgical technique might offer an alternative for angioplasty with bare-metal stent-implantation.
The current study was designed as a randomized controlled multicenter trial comparing two strategies.
- Conditions
- Coronary Artery Disease
- Being tested
- Coronary Revascularization
- Keywords
- Symptomatic Coronary Artery Disease Patients
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary RevascularizationProcedure or surgery
Also called Stenting, PCI, OPCAB, MICAB
revascularization of coronary arteries in case of symptomatic obstructive coronary artery disease
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Coronary Intervention | Active comparator | Not described Receives: Procedure: Coronary Revascularization |
| Off Pump Coronary Artery Bypass Surgery | Experimental | Not described Receives: Procedure: Coronary Revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Events
Measured: 7.5 years
Secondary outcomes (4)
Quality of Life
Measured: 7.5 years
Neurocognitive outcome
Measured: 7.5 years
Cost effectiveness
Measured: 7.5 years
Angiographical patency of revascularization
Measured: 7.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startJan 1998
- Primary completionJan 2001
- Study completionFeb 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- St. Antonius Hospital, Isala
- Investigators
- Hendrik M Nathoe, MD PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975858
- Sponsor's protocol ID
- WOM protocol 98/009
- Acronym
- OCTOSTENT
- Status last verified
- Sep 2009
- First submitted
- 11 Sep 2009
- Last updated
- 15 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 14656913
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00975858
- Acronym / sponsor ID
- OCTOSTENT / WOM protocol 98/009
- Conditions
- Coronary Artery Disease
- Keywords
- Symptomatic Coronary Artery Disease Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- St. Antonius Hospital, Isala
- Study start
- Jan 1998
- Primary completion
- Jan 2001 (actual)
- Study completion
- Feb 2001 (actual)
- First posted
- 14 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Coronary artery bypass surgery with use of the heart lung machine (on-pump surgery), is associated with the risk of peri-operative complications such as death, stroke, myocardial infarction, neurocognitive decline, and extended hospitalization. Bypass surgery on the beating heart without the use of the heart lung machine (off-pump surgery) has been reintroduced in clinical practice in order to reduce these complications. The Octopus cardiac wall stabilizer, developed at the UMC Utrecht, facilitates the safe construction of the grafts during the off-pump procedure. The expected advantages of off-pump surgery e.g. less-invasiveness, complete arterial revascularization, faster recovery and lower costs were the basis for the Octostent trial. We hypothesized that the off-pump surgical technique might offer an alternative for angioplasty with bare-metal stent-implantation.
The current study was designed as a randomized controlled multicenter trial comparing two strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Coronary Intervention | Active comparator | Procedure: Coronary Revascularization |
| Off Pump Coronary Artery Bypass Surgery | Experimental | Procedure: Coronary Revascularization |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with coronary artery disease referred for PCI in which both Off Pump Coronary Bypass surgery and PCI were deemed technically feasible
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary RevascularizationAlso: Stenting, PCI, OPCAB, MICABrevascularization of coronary arteries in case of symptomatic obstructive coronary artery disease | Procedure or surgery | Off Pump Coronary Artery Bypass Surgery, Percutaneous Coronary Intervention |
Primary outcome
Major Adverse Cardiac Events
Time frame: 7.5 years
4 secondary outcomes
Quality of Life
Time frame: 7.5 years
Neurocognitive outcome
Time frame: 7.5 years
Cost effectiveness
Time frame: 7.5 years
Angiographical patency of revascularization
Time frame: 7.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2009.
- Results publication: PubMed 14656913Eefting 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hendrik M Nathoe, MD PhD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary Revascularization in people with Coronary Artery Disease, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Events (time frame: 7.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00975858, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2009.