Coronary Artery DiseasePhase 4COPENCT00852215
Do Cobalt Chrome Stent and Paclitaxel-Eluting Stent Have Equivalent Clinical Result in Non-Complex Lesion?
A Phase 4 study testing Taxus stent and Vision stent in people with Coronary Artery Disease, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
We sought to evaluate the long-term safety and efficacy of drug-eluting stent in large vessels compared with bare metal stent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Taxus stent and Vision stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2008to Jul 2010
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Angiographically proved significant stenosis in native coronary artery (> 50% diameter stenosis with ischemic symptoms or positive functional study, or > 70% diameter stenosis without ischemic symptoms or positive functional study)
- planned target lesion number =< 2
- reference diameter 2.75 - 4.0 mm
- lesions can be fully covered by one 28 mm or shorter stent
Who cannot join
- unprotected left main coronary disease with more than 50% stenosis or planned left main angioplasty
- ostial target lesion (within 5 mm of ostium)
- angiographic evidence of thrombus within target lesion
- calcified lesions which cannot be successfully predilated
- instent restenosis
- multi-vessel intervention more than 2 lesions
Show all 10Show fewer
- atherectomy is planned before stenting
- bifurcation lesion that needs side branch ballooning or stenting
- Severe left ventricular dysfunction with echocardiographic ejection fraction less than 30%
- ST-elevation myocardial infarction within the preceding 72 hours
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
Hyoen-Cheol Gwon, MD,PhD, 82-2-3410-3418, hcgwon@skku.edu
Young Bin Song, MD, 82-2-3410-3419, youngbin.song@gmail.com
About this study
Official title: Do Cobalt Chrome Stent and Paclitaxel-Eluting Stent Have Equivalent Clinical Result in Non-Complex Lesion? (COPE Study): Long-Term Follow-up Study
We sought to evaluate the long-term safety and efficacy of drug-eluting stent in large vessels compared with bare metal stent.
Read the detailed description
Drug-eluting stent (DES) has been proved to reduced restenosis rate dramatically compared to bare metal stent (BMS). However, the long-term safety of DES is still uncertain. Recent meta-analysis showed that very late stent thrombosis rate was higher in DES group although overall mortality was similar between 2 groups.
The safety issue of DES was first suggested in the BASKET-LATE study, which compared cobalt chromium alloy BMS (VISION®, Guidant, USA) with sirolimus- or paclitaxel-coated DES. The study showed a significantly higher rate of death or myocardial infarction in the DES group between 7 and 18 month after the procedure (BMS 1.3%, DES 4.9%, p=0.01). Moreover, benefit to reduce target vessel revascularization was not found and there was even the possibility of late harm in patients treated with DES in large native vessels.
We perform a multicenter prospective randomized study comparing paclitaxel-eluting stent with cobalt chromium stent several years, originally to see whether major adverse cardiac event is significantly lower in DES compared to thin-strut BMS in the non-complex lesion subset. In this article, we would like to investigate the 2-year clinical events in DES and BMS groups.
- Conditions
- Coronary Artery Disease
- Being tested
- Taxus stent, Vision stent
- Keywords
- Angioplasty, Transluminal, Percutaneous Coronary, Paclitaxel-eluting stent, Vision stent
- 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.
Taxus stentDevice
Stenting with Paclitaxel-eluting coronary stent system for coronary lesions with > 50% diameter stenosis with ischemic symptoms or positive functional study, or > 70% diameter stenosis without ischemic symptoms or positive functional study
Vision stentDevice
Stenting with VISION coronary stent system for coronary lesions with > 50% diameter stenosis with ischemic symptoms or positive functional study, or > 70% diameter stenosis without ischemic symptoms or positive functional study
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Taxus stent group Receives: Device: Taxus stent |
| 2 | Active comparator | Vision stent group Receives: Device: Vision stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac event (MACE: cardiac death, myocardial infarction, or target vessel revascularization)
Measured: 1 year
Secondary outcomes (1)
MACE and stent thrombosis by the criteria of Academic Research Consortium
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startAug 2008
- Primary completionJul 2009 (estimated)
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Hyeon-Cheol Gwon, MD,PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852215
- Sponsor's protocol ID
- 2008-07-014
- Acronym
- COPE
- Status last verified
- Feb 2009
- First submitted
- 25 Feb 2009
- Last updated
- 26 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Cobalt Chrome Stent and Paclitaxel-Eluting Stent Have Equivalent Clinical Result in Non-Complex Lesion? (COPE Study): Long-Term Follow-up Study
- ClinicalTrials.gov ID
- NCT00852215
- Acronym / sponsor ID
- COPE / 2008-07-014
- Conditions
- Coronary Artery Disease
- Keywords
- Angioplasty, Transluminal, Percutaneous Coronary, Paclitaxel-eluting stent, Vision stent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 26 Feb 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.
We sought to evaluate the long-term safety and efficacy of drug-eluting stent in large vessels compared with bare metal stent.
Detailed description
Drug-eluting stent (DES) has been proved to reduced restenosis rate dramatically compared to bare metal stent (BMS). However, the long-term safety of DES is still uncertain. Recent meta-analysis showed that very late stent thrombosis rate was higher in DES group although overall mortality was similar between 2 groups.
The safety issue of DES was first suggested in the BASKET-LATE study, which compared cobalt chromium alloy BMS (VISION®, Guidant, USA) with sirolimus- or paclitaxel-coated DES. The study showed a significantly higher rate of death or myocardial infarction in the DES group between 7 and 18 month after the procedure (BMS 1.3%, DES 4.9%, p=0.01). Moreover, benefit to reduce target vessel revascularization was not found and there was even the possibility of late harm in patients treated with DES in large native vessels.
We perform a multicenter prospective randomized study comparing paclitaxel-eluting stent with cobalt chromium stent several years, originally to see whether major adverse cardiac event is significantly lower in DES compared to thin-strut BMS in the non-complex lesion subset. In this article, we would like to investigate the 2-year clinical events in DES and BMS groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Taxus stentTaxus stent group |
| 2 | Active comparator | Device: Vision stentVision stent group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Angiographically proved significant stenosis in native coronary artery (> 50% diameter stenosis with ischemic symptoms or positive functional study, or > 70% diameter stenosis without ischemic symptoms or positive functional study)
- planned target lesion number =< 2
- reference diameter 2.75 - 4.0 mm
- lesions can be fully covered by one 28 mm or shorter stent
Key exclusion criteria (10 listed)
- unprotected left main coronary disease with more than 50% stenosis or planned left main angioplasty
- ostial target lesion (within 5 mm of ostium)
- angiographic evidence of thrombus within target lesion
- calcified lesions which cannot be successfully predilated
- instent restenosis
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 |
|---|---|---|
| Taxus stentStenting with Paclitaxel-eluting coronary stent system for coronary lesions with > 50% diameter stenosis with ischemic symptoms or positive functional study, or > 70% diameter stenosis without ischemic symptoms or positive functional study | Device | 1 |
| Vision stentStenting with VISION coronary stent system for coronary lesions with > 50% diameter stenosis with ischemic symptoms or positive functional study, or > 70% diameter stenosis without ischemic symptoms or positive functional study | Device | 2 |
Primary outcome
Major adverse cardiac event (MACE: cardiac death, myocardial infarction, or target vessel revascularization)
Time frame: 1 year
1 secondary outcome
MACE and stent thrombosis by the criteria of Academic Research Consortium
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2009.
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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.
Hyeon-Cheol Gwon, MD,PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Taxus stent and Vision stent in people with Coronary Artery Disease, run by Samsung Medical Center at 1 site in South Korea.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 26 Feb 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyeon-Cheol Gwon, MD,PhD (82-2-3410-3418, hcgwon@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac event (MACE: cardiac death, myocardial infarction, or target vessel revascularization) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2009.