Coronary Artery DiseasePhase 4NCT01489761
LONG-DES VI (Drug Eluting Stent for Long Lesions in Coronary Artery)
A Phase 4 study testing percutaneous coronary intervention in people with Coronary Artery Disease, run by Seung-Jung Park at 11 sites in South Korea.
Trial summary
This is a multi-center, randomized, study to compare the efficacy of zotarolimus-eluting stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime or Xience Xpedition or Xience Alpine stent) for very long coronary lesions. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- percutaneous coronary intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 11 sitesSouth Korea
- Study dates
- Jan 2012to 14 Feb 2017
- 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
- Age more than 20 years
- Significant native coronary artery stenosis (> 50% by visual estimate) with lesion length of more than 50mm, which requires at least 2 multiple long stent placement without intervening normal segment
- Patients with silent ischemia, stable or unstable angina pectoris, and Non-ST-elevation myocardial infarction (NSTEMI)
- The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site
Who cannot join
- Any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, zotarolimus, or everolimus
- An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment
- Acute ST-segment-elevation MI or cardiogenic shock
- Terminal illness with life expectancy < 1 year
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
- In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment) However, non-target vessel In-stent restenosis is permitted
Show all 9Show fewer
- Patients with EF < 30%
- Serum creatinine level >=2.0mg/dL or dependence on dialysis
- Patients with left main stem stenosis (> 50% visual estimate)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
South Korea11 sites
Gangwon National Univ. Hospital
Chuncheon
Keimyung University Dongsan Medical Center
Daegu
Kyungpook National university hospital
Daegu
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon
Chonnam National University Hospital
Gwangju
National Health Insurance Service Ilsan Hospital
Ilsan
Korea University Guro Hospital
Seoul
Kyunghee University Medical Center
Seoul
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul
St.carollo Hospital
Suncheon
Pusan National University Yangsan Hospital
Yangsan
About this study
Official title: Percutaneous Treatment of Very LONG Native Coronary Lesions With Drug-Eluting Stent-VI: Everolimus-eluting Versus Zotarolimus-Eluting Stents
This is a multi-center, randomized, study to compare the efficacy of zotarolimus-eluting stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime or Xience Xpedition or Xience Alpine stent) for very long coronary lesions.
Read the detailed description
Following angiography, patients with significant diameter stenosis > 50% and lesion length (> 50mm) requiring at least 2 multiple long-stent placement by visual estimation and eligible for LONG-DES VI trial inclusion and exclusion criteria will be randomized 1:1 to zotarolimus-eluting stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime or Xience Xpedition or Xience Alpine stent) by the stratified randomization method.
- Conditions
- Coronary Artery Disease
- Being tested
- percutaneous coronary intervention
- Keywords
- long lesions, drug eluting stents
- 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.
percutaneous coronary interventionDevice
Also called Resolute Integrity or Resolute Onyx stent, Xience Prime or Xience Xpedition or Xience Alpine stent
drug eluting stent implantation
| Study group | Role | What they receive |
|---|---|---|
| zotarolimus-eluting stent | Active comparator | Resolute Integrity or Resolute Onyx stent Receives: Device: percutaneous coronary intervention |
| everolimus-eluting stent | Experimental | Xience Prime or Xience Xpedition or Xience Alpine stent Receives: Device: percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-segment late luminal loss at 13 month follow-up
Measured: 13 month post stenting
Secondary outcomes (15)
1. All Death
Measured: 12 month clinical follow-up
2. Cardiac death
Measured: 12 month clinical follow-up
3. Myocardial infarction (MI)
Measured: 12 month clinical follow-up
4. Composite of death or MI
Measured: 12 month clinical follow-up
5. Composite of cardiac death or MI
Measured: 12 month clinical follow-up
6. Target vessel revascularization (ischemia-driven and clinically-driven)
Measured: 12 month clinical follow-up
7. Target lesion revascularization (ischemia-driven and clinically-driven)
Measured: 12 month clinical follow-up
8. Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)
Measured: 12 month clinical follow-up
9. Stent thrombosis (ARC criteria)
Measured: 12 month clinical follow-up
10. In-stent late loss
Measured: 13 month angiographic follow-up
11. In-stent and in-segment restenosis
Measured: 13 month angiographic follow-up
12. Angiographic pattern of restenosis
Measured: 13 month angiographic follow-up
13. Volume of intimal hyperplasia
sub-study
Measured: 13 month IVUS follow-up
14. Incidence of late stent malapposition
sub-study
Measured: 13 month IVUS follow-up
15. Procedural success defined as achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion during the hospital stay
Measured: 2-3 days post stenting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2011 (estimated)
- Study startJan 2012
- Primary completion14 Feb 2017
- Study completion14 Feb 2017
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.
- 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
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Seung-Jung Park, CardioVascular Research Foundation, Korea
- Investigators
- Seung-Jung Park, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489761
- Sponsor's protocol ID
- CVRF2011-9
- Status last verified
- Feb 2017
- First submitted
- 8 Dec 2011
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: This is not a publicly funded trial.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Treatment of Very LONG Native Coronary Lesions With Drug-Eluting Stent-VI: Everolimus-eluting Versus Zotarolimus-Eluting Stents
- ClinicalTrials.gov ID
- NCT01489761
- Acronym / sponsor ID
- CVRF2011-9
- Conditions
- Coronary Artery Disease
- Keywords
- long lesions, drug eluting stents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- Abbott, CardioVascular Research Foundation, Korea
- Study start
- Jan 2012 (actual)
- Primary completion
- 14 Feb 2017 (actual)
- Study completion
- 14 Feb 2017 (actual)
- First posted
- 12 Dec 2011 (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 is a multi-center, randomized, study to compare the efficacy of zotarolimus-eluting stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime or Xience Xpedition or Xience Alpine stent) for very long coronary lesions.
Detailed description
Following angiography, patients with significant diameter stenosis > 50% and lesion length (> 50mm) requiring at least 2 multiple long-stent placement by visual estimation and eligible for LONG-DES VI trial inclusion and exclusion criteria will be randomized 1:1 to zotarolimus-eluting stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime or Xience Xpedition or Xience Alpine stent) by the stratified randomization method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zotarolimus-eluting stent | Active comparator | Device: percutaneous coronary interventionResolute Integrity or Resolute Onyx stent |
| everolimus-eluting stent | Experimental | Device: percutaneous coronary interventionXience Prime or Xience Xpedition or Xience Alpine stent |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age more than 20 years
- Significant native coronary artery stenosis (> 50% by visual estimate) with lesion length of more than 50mm, which requires at least 2 multiple long stent placement without intervening normal segment
- Patients with silent ischemia, stable or unstable angina pectoris, and Non-ST-elevation myocardial infarction (NSTEMI)
- The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site
Key exclusion criteria (9 listed)
- Any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, zotarolimus, or everolimus
- An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment
- Acute ST-segment-elevation MI or cardiogenic shock
- Terminal illness with life expectancy < 1 year
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
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 |
|---|---|---|
| percutaneous coronary interventionAlso: Resolute Integrity or Resolute Onyx stent, Xience Prime or Xience Xpedition or Xience Alpine stentdrug eluting stent implantation | Device | everolimus-eluting stent, zotarolimus-eluting stent |
Primary outcome
In-segment late luminal loss at 13 month follow-up
Time frame: 13 month post stenting
15 secondary outcomes
1. All Death
Time frame: 12 month clinical follow-up
2. Cardiac death
Time frame: 12 month clinical follow-up
3. Myocardial infarction (MI)
Time frame: 12 month clinical follow-up
4. Composite of death or MI
Time frame: 12 month clinical follow-up
5. Composite of cardiac death or MI
Time frame: 12 month clinical follow-up
6. Target vessel revascularization (ischemia-driven and clinically-driven)
Time frame: 12 month clinical follow-up
7. Target lesion revascularization (ischemia-driven and clinically-driven)
Time frame: 12 month clinical follow-up
8. Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)
Time frame: 12 month clinical follow-up
9. Stent thrombosis (ARC criteria)
Time frame: 12 month clinical follow-up
10. In-stent late loss
Time frame: 13 month angiographic follow-up
11. In-stent and in-segment restenosis
Time frame: 13 month angiographic follow-up
12. Angiographic pattern of restenosis
Time frame: 13 month angiographic follow-up
13. Volume of intimal hyperplasia
Time frame: 13 month IVUS follow-up
14. Incidence of late stent malapposition
Time frame: 13 month IVUS follow-up
15. Procedural success defined as achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion during the hospital stay
Time frame: 2-3 days post stenting
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
- Individual participant dataSharing planned: No. This is not a publicly funded trial.
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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.
Seung-Jung Park, MD, PhD principal investigator
Asan Medical Center
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing percutaneous coronary intervention in people with Coronary Artery Disease, run by Seung-Jung Park at 11 sites 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 9 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: stopped early, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 was stopped early. Results are not available in the source record.
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?
In-segment late luminal loss at 13 month follow-up (time frame: 13 month post stenting). 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 24 Feb 2017.