Coronary Artery DiseaseLONG-DES VIINCT03484234
Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-VII: Sirolimus-eluting (Ultimaster) vs. Everolimus-Eluting Stents (Xience)
A study testing Ultimaster stent and Xience alpine stent in people with Coronary Artery Disease and Coronary Stenosis, run by Seung-Jung Park at 2 sites in South Korea.
Trial summary
This study compares angiographic and clinical outcomes in patients with long coronary lesions treated with sirolimus-eluting stent (Ultimaster stent) or everolimus-eluting stent (Xience Alpine stent). The study uses a randomized, multicenter, controlled design approach. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Stenosis
- What is being tested?
- Ultimaster stent and Xience alpine stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 27 Jul 2018to 6 Sep 2019
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must be at least 19 years of age.
- Significant native coronary artery stenosis (>50% by visual estimate) with lesion length of more than 25mm, which requiring at long stent placement without intervening normal segment.
- Patients with silent ischemia, stable or unstable angina pectoris, ad 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, sirolimus, 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
- In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment). However, non-target vessel ISR is permitted.
- Patients with EF<30%.
- Serum creatinine level ≥ 2.0mg/dL or dependence on dialysis.
- Patients with left main stem stenosis (>50% by visual estimate)
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Gangwon National Univ. Hospital
Chuncheon
Asan Medical Center
Seoul
About this study
Official title: A Multi-center, Randomized, Study to Compare the Effectiveness of Sirolimus-eluting Stent (Ultimaster Stent) or Everolimus-eluting Stent (XIience Alpine Stent) for Long Coronary Lesions.
This study compares angiographic and clinical outcomes in patients with long coronary lesions treated with sirolimus-eluting stent (Ultimaster stent) or everolimus-eluting stent (Xience Alpine stent). The study uses a randomized, multicenter, controlled design approach.
- Conditions
- Coronary Artery Disease, Coronary Stenosis
- Being tested
- Ultimaster stent, Xience alpine stent
- Keywords
- Drug eluting stent, everolimus eluting stent, sirolimus eluting stent
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultimaster stentDevice
Percutaneous coronary intervention with Ultimaster stent for long lesion
Xience alpine stentDevice
Percutaneous coronary intervention with Xience alpine stent for long lesion
| Study group | Role | What they receive |
|---|---|---|
| Ultimaster stent | Experimental | Not described Receives: Device: Ultimaster stent |
| Xience alpine stent | Active comparator | Not described Receives: Device: Xience alpine stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-segment late luminal loss
Measured: 13-month
Secondary outcomes (15)
All death
Measured: 1 year
Cardiac death
Measured: 1 year
Myocardial infarction (MI)
Measured: 1 year
Composite of death or MI
Measured: 1 year
Composite of cardiac death or MI
Measured: 1 year
Target vessel revascularization (ischemia-driven and clinically-driven)
Measured: 1 year
Target lesion revascularization (ischemia-driven and clinically-driven)
Measured: 1 year
Target-vessel failure
death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization
Measured: 1 year
Stent thrombosis
Measured: 1 year
In-stent late loss
In-stent late loss at 13-month angiographic follow-up
Measured: 13-month
In-stent and in-segment restenosis
In-stent and in-segment restenosis at 13-month angiographic follow-up
Measured: 13-month
Angiographic pattern of restenosis
Angiographic pattern of restenosis at 13 -month angiographic follow-up
Measured: 13-month
Volume of intimal hyperplasia
Volume of intimal hyperplasia at 13-month IVUS follow-up (sub-study)
Measured: 13-month
Incidence of late stent malapposition
Incidence of late stent malapposition at 13-month IVUS follow-up (sub-study)
Measured: 13-month
Procedural success
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: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start27 Jul 2018
- Primary completion6 Sep 2019
- Study completion6 Sep 2019
Why it stopped: At sponsor's discretion : The purpose of study is no longer maintained
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Seung-Jung Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484234
- Sponsor's protocol ID
- AMCCV2018-05
- Acronym
- LONG-DES VII
- Status last verified
- Sep 2019
- First submitted
- 22 Mar 2018
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Study to Compare the Effectiveness of Sirolimus-eluting Stent (Ultimaster Stent) or Everolimus-eluting Stent (XIience Alpine Stent) for Long Coronary Lesions.
- ClinicalTrials.gov ID
- NCT03484234
- Acronym / sponsor ID
- LONG-DES VII / AMCCV2018-05
- Conditions
- Coronary Artery Disease, Coronary Stenosis
- Keywords
- Drug eluting stent, everolimus eluting stent, sirolimus eluting stent
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: At sponsor's discretion : The purpose of study is no longer maintained
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- 27 Jul 2018 (actual)
- Primary completion
- 6 Sep 2019 (actual)
- Study completion
- 6 Sep 2019 (actual)
- First posted
- 30 Mar 2018 (actual)
- 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 compares angiographic and clinical outcomes in patients with long coronary lesions treated with sirolimus-eluting stent (Ultimaster stent) or everolimus-eluting stent (Xience Alpine stent). The study uses a randomized, multicenter, controlled design approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultimaster stent | Experimental | Device: Ultimaster stent |
| Xience alpine stent | Active comparator | Device: Xience alpine stent |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient must be at least 19 years of age.
- Significant native coronary artery stenosis (>50% by visual estimate) with lesion length of more than 25mm, which requiring at long stent placement without intervening normal segment.
- Patients with silent ischemia, stable or unstable angina pectoris, ad 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 (8 listed)
- Any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, sirolimus, 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
- In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment). However, non-target vessel ISR is permitted.
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 |
|---|---|---|
| Ultimaster stentPercutaneous coronary intervention with Ultimaster stent for long lesion | Device | Ultimaster stent |
| Xience alpine stentPercutaneous coronary intervention with Xience alpine stent for long lesion | Device | Xience alpine stent |
Primary outcome
In-segment late luminal loss
Time frame: 13-month
15 secondary outcomes
All death
Time frame: 1 year
Cardiac death
Time frame: 1 year
Myocardial infarction (MI)
Time frame: 1 year
Composite of death or MI
Time frame: 1 year
Composite of cardiac death or MI
Time frame: 1 year
Target vessel revascularization (ischemia-driven and clinically-driven)
Time frame: 1 year
Target lesion revascularization (ischemia-driven and clinically-driven)
Time frame: 1 year
Target-vessel failure
Time frame: 1 year
Stent thrombosis
Time frame: 1 year
In-stent late loss
Time frame: 13-month
In-stent and in-segment restenosis
Time frame: 13-month
Angiographic pattern of restenosis
Time frame: 13-month
Volume of intimal hyperplasia
Time frame: 13-month
Incidence of late stent malapposition
Time frame: 13-month
Procedural success
Time frame: 5 days
Results and safety
The study was stopped early (reason given: At sponsor's discretion : The purpose of study is no longer maintained). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultimaster stent and Xience alpine stent in people with Coronary Artery Disease and Coronary Stenosis, run by Seung-Jung Park at 2 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 8 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 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
The study was stopped early (reason given: At sponsor's discretion : The purpose of study is no longer maintained). 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 (time frame: 13-month). 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 10 Sep 2019.