Multi-vessel Diseases, AnginaPhase 4NCT01856374
Serial EValuation of multiplE Coronary Artery Diseases by an Optical Coherence Tomography; Assessment of the Changes of de Novo Lesions and Comparisons of Neointimal Coverage Between Xience Prime® Versus Cypher SelectTM Stents; SEVEN-Xience Study
A Phase 4 study testing Sirolimus-eluting stent (Cypher SelectTM, Cordis, Miami, FL), Everolimus-eluting stent(Xience Prime®, Abbott Vascular, Santa Claea, CA) and Pravastatin 20mg in people with Multi-vessel Diseases, Angina, run by Yonsei University at 1 site in South Korea.
Trial summary
This study is a prospective open-labeled, randomized study to compare the neointimal coverage at 3 months and 12 months and its serial changes between 3 months and 12 months according to the implanted DES and evaluate the serial changes in the proximal portions of 3 epicardial coronary artery and left main artery… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Multi-vessel Diseases, Angina
- What is being tested?
- Sirolimus-eluting stent (Cypher SelectTM, Cordis, Miami, FL), Everolimus-eluting stent(Xience Prime®, Abbott Vascular, Santa Claea, CA) and Pravastatin 20mg
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Oct 2014
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is ≥ 20 years old
- Patients with typical angina who are considered for coronary revascularization.
- Multi-vessel diseases: more than 2 significant coronary de novo lesions (> 70% by quantitative angiographic analysis); one of the target lesions is the most significant tight stenotic lesion causing the ischemic symptom and requiring the immediate revascularization but the others are significant but non-tight lesions to be delayed or observed for 3 months and not requiring immediate PCI for the complete revascularization of all coronary arteries.
Who cannot join
- ST-elevation MI
- Cardiogenic shock or hemodynamically unstable status
- Lesions requiring the immediate complete revascularization of all coronary stenotic lesions
- Contraindication to anti-platelet agents
- Treated with any DES within 6 months at other vessel
- Creatinine level ≥ 2.0 mg/dL or ESRD
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- Severe hepatic dysfunction (3 times normal reference values)
- Pregnant women or women with potential childbearing
- Life expectancy 1 year
- Complex lesion morphologies (bifurcation lesions treated with 2-stent techniques, untreated significant unprotected left main diseases, chronic total occlusion, in-stent restenosis, and vein graft lesion)
Trial locations and contacts
1 site in 1 country.
About this study
This study is a prospective open-labeled, randomized study to compare the neointimal coverage at 3 months and 12 months and its serial changes between 3 months and 12 months according to the implanted DES and evaluate the serial changes in the proximal portions of 3 epicardial coronary artery and left main artery including the assessment of fibrous cap thickness and lipid pool for vulnerable plaques by OCT. In addition, the investigators will compare the changes such as plaques and neointimal coverage from serial OCT follow-up according to the different statin strategy.
- Conditions
- Multi-vessel Diseases, Angina
- Being tested
- Sirolimus-eluting stent (Cypher SelectTM, Cordis, Miami, FL), Everolimus-eluting stent(Xience Prime®, Abbott Vascular, Santa Claea, CA), Pravastatin 20mg, Atorvastatin 40mg
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirolimus-eluting stent (Cypher SelectTM, Cordis, Miami, FL)Device
Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; Xience Prime® vs. Cypher SelectTM and pravastatin 20mg vs. atorvastatin 40mg.
Everolimus-eluting stent(Xience Prime®, Abbott Vascular, Santa Claea, CA)Device
Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; Xience Prime® vs. Cypher SelectTM and pravastatin 20mg vs. atorvastatin 40mg.
Pravastatin 20mgDrug
2x2 randomization by the treatment of dyslipidemia (In patients of dyslipidemia: pravastatin 20mg/day vs. atorvastatin 40mg and the types of the implanted cypher vs xience.
Atorvastatin 40mgDrug
2x2 randomization by the treatment of dyslipidemia (In patients of dyslipidemia: pravastatin 20mg/day vs. atorvastatin 40mg and the types of the implanted cypher vs xience.
| Study group | Role | What they receive |
|---|---|---|
| Cypher group | Active comparator | Not described Receives: Device: Sirolimus-eluting stent (Cypher SelectTM, Cordis, Miami, FL) |
| Xience group | Experimental | Not described Receives: Device: Everolimus-eluting stent(Xience Prime®, Abbott Vascular, Santa Claea, CA) |
| Pravastatin group | Active comparator | Not described Receives: Drug: Pravastatin 20mg |
| Atorvastatin group | Experimental | Not described Receives: Drug: Atorvastatin 40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
neointimal coverage according to the implanted DES; Xience vs. Cypher
Neointimal coverage means percentage of uncovered struts on OCT. The percentages of uncovered struts were compared between EES and SES.
Measured: up to 12month after stent implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study startAug 2011
- Primary completionMar 2014
- Study completionOct 2014
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 Multi-vessel Diseases, AnginaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856374
- Sponsor's protocol ID
- 1-2010-0052
- Status last verified
- Jul 2016
- First submitted
- 9 May 2013
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim JS, Kim JH, Shin DH, Kim BK, Ko YG, Choi D, Jang Y, Hong MK. Effect of High-Dose Statin Therapy on Drug-Eluting Stent Strut Coverage. Arterioscler Thromb Vasc Biol. 2015 Nov;35(11):2460-7. doi: 10.1161/ATVBAHA.115.306037. Epub 2015 Sep 10.
PubMed 26359512
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial EValuation of multiplE Coronary Artery Diseases by an Optical Coherence Tomography; Assessment of the Changes of de Novo Lesions and Comparisons of Neointimal Coverage Between Xience Prime® Versus Cypher SelectTM Stents; SEVEN-Xience Study
- ClinicalTrials.gov ID
- NCT01856374
- Acronym / sponsor ID
- 1-2010-0052
- Conditions
- Multi-vessel Diseases, Angina
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 17 May 2013 (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.
This study is a prospective open-labeled, randomized study to compare the neointimal coverage at 3 months and 12 months and its serial changes between 3 months and 12 months according to the implanted DES and evaluate the serial changes in the proximal portions of 3 epicardial coronary artery and left main artery including the assessment of fibrous cap thickness and lipid pool for vulnerable plaques by OCT. In addition, the investigators will compare the changes such as plaques and neointimal coverage from serial OCT follow-up according to the different statin strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cypher group | Active comparator | Device: Sirolimus-eluting stent (Cypher SelectTM, Cordis, Miami, FL) |
| Xience group | Experimental | Device: Everolimus-eluting stent(Xience Prime®, Abbott Vascular, Santa Claea, CA) |
| Pravastatin group | Active comparator | Drug: Pravastatin 20mg |
| Atorvastatin group | Experimental | Drug: Atorvastatin 40mg |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is ≥ 20 years old
- Patients with typical angina who are considered for coronary revascularization.
- Multi-vessel diseases: more than 2 significant coronary de novo lesions (> 70% by quantitative angiographic analysis); one of the target lesions is the most significant tight stenotic lesion causing the ischemic symptom and requiring the immediate revascularization but the others are significant but non-tight lesions to be delayed or observed for 3 months and not requiring immediate PCI for the complete revascularization of all coronary arteries.
Key exclusion criteria (10 listed)
- ST-elevation MI
- Cardiogenic shock or hemodynamically unstable status
- Lesions requiring the immediate complete revascularization of all coronary stenotic lesions
- Contraindication to anti-platelet agents
- Treated with any DES within 6 months at other vessel
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 |
|---|---|---|
| Sirolimus-eluting stent (Cypher SelectTM, Cordis, Miami, FL)Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; Xience Prime® vs. Cypher SelectTM and pravastatin 20mg vs. atorvastatin 40mg. | Device | Cypher group |
| Everolimus-eluting stent(Xience Prime®, Abbott Vascular, Santa Claea, CA)Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; Xience Prime® vs. Cypher SelectTM and pravastatin 20mg vs. atorvastatin 40mg. | Device | Xience group |
| Pravastatin 20mg2x2 randomization by the treatment of dyslipidemia (In patients of dyslipidemia: pravastatin 20mg/day vs. atorvastatin 40mg and the types of the implanted cypher vs xience. | Drug | Pravastatin group |
| Atorvastatin 40mg2x2 randomization by the treatment of dyslipidemia (In patients of dyslipidemia: pravastatin 20mg/day vs. atorvastatin 40mg and the types of the implanted cypher vs xience. | Drug | Atorvastatin group |
Primary outcome
neointimal coverage according to the implanted DES; Xience vs. Cypher
Time frame: up to 12month after stent implantation
Neointimal coverage means percentage of uncovered struts on OCT. The percentages of uncovered struts were compared between EES and SES.
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 27 Jul 2016.
- Derived from this study: PubMed 26359512Kim JS, Kim JH, Shin DH, Kim BK, Ko YG, Choi D, Jang Y, Hong MK. Effect of High-Dose Statin Therapy on Drug-Eluting Stent Strut Coverage. Arterioscler Thromb Vasc Biol. 2015 Nov;35(11):2460-7. doi: 10.1161/ATVBAHA.115.306037. Epub 2015 Sep 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sirolimus-eluting stent (Cypher SelectTM, Cordis, Miami, FL), Everolimus-eluting stent(Xience Prime®, Abbott Vascular, Santa Claea, CA) and Pravastatin 20mg in people with Multi-vessel Diseases, Angina, run by Yonsei University 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 3 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: finished, as of the sponsor's last update on 27 Jul 2016. 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?
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?
neointimal coverage according to the implanted DES; Xience vs. Cypher (time frame: up to 12month after stent implantation). 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 NCT01856374, 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 27 Jul 2016.