Coronary Artery DiseasePhase 4ANCHORNCT01581515
Assessment of Stent Malapposition and Neointimal Coverage on Optical coHerence Tomography at Post-procedure and 3 Months After Platinum Chromium Alloy Of the Element™ Stent Implantation
A Phase 4 study testing Promus Element everolimus eluting coronary stent and Xience Prime everolimus eluting coronary stent in people with Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the degree of stent malapposition on an immediate optical coherence tomography (OCT) after nominal stent pressure and at a final post-procedure OCT (ANCHOR-I) and the neointimal coverage on 3-months OCT following the intervention with the randomly assigned two drug-eluting… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Promus Element everolimus eluting coronary stent and Xience Prime everolimus eluting coronary stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2012to Jan 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is ≥ 20 years old
- Significant coronary de novo lesion (> 70% by quantitative angiographic analysis) treated by single DES in each vessel.
- Patients with stable angina who are considered for coronary revascularization with stent implantation.
- Reference vessel diameter of 2.5 to 3.5 mm by operator assessment
Who cannot join
- Complex lesion morphologies such as aorto-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, and restenosis
- Reference vessel diameter < 2.5 mm or > 4.0mm and lesion length > 28 mm
- Heavy calcified lesions (definite calcified lesions on angiogram)
- Lesions requiring more than 2 DES in each vessel
- Acute coronary syndrome
- Contraindication to anti-platelet agents
Show all 11Show fewer
- Treated with any DES within 3 months at other vessel
- Creatinine level ≥ 2.0 mg/dL or ESRD
- Severe hepatic dysfunction (3 times normal reference values)
- Pregnant women or women with potential childbearing
- Life expectancy 1 year
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul, Seodaemun-gu/Sinchon-dong, 120-752
Shin-young Park, Staff, +82 2 2228 0453, smile@yuhs.ac
Myeong-Ki Hong, MD.PhD
About this study
Official title: 2-phased Randomized Comparison Between PromusTMElementTM Versus Xience PRIME® Stent
The purpose of this study is to compare the degree of stent malapposition on an immediate optical coherence tomography (OCT) after nominal stent pressure and at a final post-procedure OCT (ANCHOR-I) and the neointimal coverage on 3-months OCT following the intervention with the randomly assigned two drug-eluting stents (DES), PromusTMElementTM stents versus Xience PRIME® stents.
- Conditions
- Coronary Artery Disease
- Being tested
- Promus Element everolimus eluting coronary stent, Xience Prime everolimus eluting coronary 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.
Promus Element everolimus eluting coronary stentDevice
Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime
Xience Prime everolimus eluting coronary stentDevice
Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime
| Study group | Role | What they receive |
|---|---|---|
| P-E group | Active comparator | Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime Receives: Device: Promus Element everolimus eluting coronary stent |
| X-P group | Active comparator | Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime Receives: Device: Xience Prime everolimus eluting coronary stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
the ratio of the malapposed strut
The ratio of the malapposed strut, on an immediate OCT after nominal stent pressure and at a final post-procedure between two different DES; ANCHOR-I
Measured: Participants will be followed from first OCT invervention to 3month OCT following intervention
Secondary outcomes (5)
Incidence of stent malapposition
Measured: 3months OCT following intervention
Neointimal coverage(ANCHOR II)
Measured: 3 month-OCT after stent implantation
Incidence of plaque prolapse
Measured: final postprocedural OCT
Evaluation of stent expansion
Measured: an immediate and post-procedural OCT
Stent malapposition
Measured: on 3 month OCT intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
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 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myeong-Ki Hong, Yonsei University
- Investigators
- Myeong-Ki Hong, MD.PhD., Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01581515
- Sponsor's protocol ID
- 1-2011-0080
- Acronym
- ANCHOR
- Status last verified
- Apr 2012
- First submitted
- 11 Apr 2012
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim BK, Shin DH, Kim JS, Ko YG, Choi D, Jang Y, Hong MK. Randomized comparison of acute stent malapposition between platinum-chromium versus cobalt-chromium everolimus-eluting stents. Int J Cardiovasc Imaging. 2015 Feb;31(2):269-77. doi: 10.1007/s10554-014-0557-y. Epub 2014 Oct 28.
PubMed 25345751
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2-phased Randomized Comparison Between PromusTMElementTM Versus Xience PRIME® Stent
- ClinicalTrials.gov ID
- NCT01581515
- Acronym / sponsor ID
- ANCHOR / 1-2011-0080
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 20 Apr 2012 (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 purpose of this study is to compare the degree of stent malapposition on an immediate optical coherence tomography (OCT) after nominal stent pressure and at a final post-procedure OCT (ANCHOR-I) and the neointimal coverage on 3-months OCT following the intervention with the randomly assigned two drug-eluting stents (DES), PromusTMElementTM stents versus Xience PRIME® stents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P-E group | Active comparator | Device: Promus Element everolimus eluting coronary stentPatients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime |
| X-P group | Active comparator | Device: Xience Prime everolimus eluting coronary stentPatients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is ≥ 20 years old
- Significant coronary de novo lesion (> 70% by quantitative angiographic analysis) treated by single DES in each vessel.
- Patients with stable angina who are considered for coronary revascularization with stent implantation.
- Reference vessel diameter of 2.5 to 3.5 mm by operator assessment
Key exclusion criteria (11 listed)
- Complex lesion morphologies such as aorto-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, and restenosis
- Reference vessel diameter < 2.5 mm or > 4.0mm and lesion length > 28 mm
- Heavy calcified lesions (definite calcified lesions on angiogram)
- Lesions requiring more than 2 DES in each vessel
- Acute coronary syndrome
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 |
|---|---|---|
| Promus Element everolimus eluting coronary stentPatients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime | Device | P-E group |
| Xience Prime everolimus eluting coronary stentPatients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime | Device | X-P group |
Primary outcome
the ratio of the malapposed strut
Time frame: Participants will be followed from first OCT invervention to 3month OCT following intervention
The ratio of the malapposed strut, on an immediate OCT after nominal stent pressure and at a final post-procedure between two different DES; ANCHOR-I
5 secondary outcomes
Incidence of stent malapposition
Time frame: 3months OCT following intervention
Neointimal coverage(ANCHOR II)
Time frame: 3 month-OCT after stent implantation
Incidence of plaque prolapse
Time frame: final postprocedural OCT
Evaluation of stent expansion
Time frame: an immediate and post-procedural OCT
Stent malapposition
Time frame: on 3 month OCT intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2012.
- Derived from this study: PubMed 25345751Kim BK, Shin DH, Kim JS, Ko YG, Choi D, Jang Y, Hong MK. Randomized comparison of acute stent malapposition between platinum-chromium versus cobalt-chromium everolimus-eluting stents. Int J Cardiovasc Imaging. 2015 Feb;31(2):269-77. doi: 10.1007/s10554-014-0557-y. Epub 2014 Oct 28.
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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.
Myeong-Ki Hong, MD.PhD. principal investigator
Severance Hospital
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 Promus Element everolimus eluting coronary stent and Xience Prime everolimus eluting coronary stent in people with Coronary Artery Disease, 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 4 inclusion and 11 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 20 Apr 2012. 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 Myeong-Ki Hong, MD.PhD. (+82 2 2228 8458, mkhong61@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the ratio of the malapposed strut (time frame: Participants will be followed from first OCT invervention to 3month OCT following intervention). 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 NCT01581515, 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 20 Apr 2012.