Coronary Artery DiseaseNCT01869842
Randomized Controlled Study of the Traditional Percutaneous Coronary Intervention and Intervention Using Optical Coherence Tomography of Incomplete Stent Adhesion and Extent of the Formation of Neointima by Resolute Zotarolimus-eluting Stent Insertion
A study testing percutaneous coronary intervention and OCT-guided percutaneous coronary intervention in people with Coronary Artery Disease and Stable Angina, run by Yonsei University at 1 site in South Korea.
Trial summary
Optical coherence tomography (OCT) after the stent procedure to improve the adhesion and expansion, or incomplete uncovered struts attached to the main track. OCT in clinical areas by improving the parameters of the best stent will be useful. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease, Stable Angina, Unstable Angina
- What is being tested?
- percutaneous coronary intervention and OCT-guided percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to Dec 2016
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single lesion in a Single vessel
- Reference vessel diameter 2.5 - 3.5 mm
- Lesion length ≤ 34 mm and ≤ 34 mm stent length
- Stable angina requiring revascularization, patients with unstable angina
- The patient has no difficulty to enforce the follow-up angiography
- Patient is ≥ 20 years old
Who cannot join
- Lesions with graft vessel, thrombosis, restenosis, and bifurcation requiring 2 stents
- Reference vessel diameter < 2.5 mm or > 4.0mm
- Contraindication to anti-platelet agents
- 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)
Show all 14Show fewer
- Patients with LVEF < 30%
- Life expectancy 1 year
- Lesions with CTO or left main
- Target vessel of ST-elevation MI
- Lesions requiring overlapped stenting or more than 2 DES in each vessel
- Heavy calcified lesions (definite calcified lesions on angiogram)
- Far distal or tortuous lesions having difficulties in OCT evaluation or follow-up OCT
- Pregnant women or women with potential childbearing
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul, Seoul, 120-752
MyeongKi Hong, MD, PhD, 82-2-2228-8460, mkhong61@yuhs.ac
Myeong Ki Hong, MD, PhD
About this study
Optical coherence tomography (OCT) after the stent procedure to improve the adhesion and expansion, or incomplete uncovered struts attached to the main track. OCT in clinical areas by improving the parameters of the best stent will be useful. However, for better results for optical coherence tomography in percutaneous interventions have little useful data on the role. Randomized controlled study of the traditional percutaneous coronary intervention and intervention using optical coherence tomography.
- Conditions
- Coronary Artery Disease, Stable Angina, Unstable Angina
- Being tested
- percutaneous coronary intervention, OCT-guided percutaneous coronary intervention
- Keywords
- Resolute zotarolumus-eluting stent, optical coherence tomography
- Medical subject headings
- Coronary Artery Disease, Angina, Stable, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous coronary interventionProcedure or surgery
the traditional percutaneous coronary intervention by Resolute zotarolimus-eluting stent insertion
OCT-guided percutaneous coronary interventionProcedure or surgery
the percutaneous coronary intervention using optical coherence tomography by Resolute zotarolimus-eluting stent insertion
percutaneous coronary interventionProcedure or surgery
the traditional percutaneous coronary intervention by Resolute zotarolimus-eluting stent insertion
OCT-guided percutaneous coronary interventionProcedure or surgery
the percutaneous coronary intervention using optical coherence tomography by Resolute zotarolimus-eluting stent insertion
| Study group | Role | What they receive |
|---|---|---|
| DM, angio group | Active comparator | Not described Receives: Procedure: percutaneous coronary intervention |
| DM, OCT group | Experimental | Not described Receives: Procedure: OCT-guided percutaneous coronary intervention |
| non DM, angio group | Active comparator | Not described Receives: Procedure: percutaneous coronary intervention |
| non DM, OCT group | Experimental | Not described Receives: Procedure: OCT-guided percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
ratio of the stent strut
Measured: Angiographic follow-up with OCT at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startDec 2011
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869842
- Sponsor's protocol ID
- 1-2011-0070
- Status last verified
- May 2013
- First submitted
- 31 May 2013
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of the Traditional Percutaneous Coronary Intervention and Intervention Using Optical Coherence Tomography of Incomplete Stent Adhesion and Extent of the Formation of Neointima by Resolute Zotarolimus-eluting Stent Insertion
- ClinicalTrials.gov ID
- NCT01869842
- Acronym / sponsor ID
- 1-2011-0070
- Conditions
- Coronary Artery Disease, Stable Angina, Unstable Angina
- Keywords
- Resolute zotarolumus-eluting stent, optical coherence tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 5 Jun 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.
Optical coherence tomography (OCT) after the stent procedure to improve the adhesion and expansion, or incomplete uncovered struts attached to the main track. OCT in clinical areas by improving the parameters of the best stent will be useful. However, for better results for optical coherence tomography in percutaneous interventions have little useful data on the role. Randomized controlled study of the traditional percutaneous coronary intervention and intervention using optical coherence tomography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DM, angio group | Active comparator | Procedure: percutaneous coronary intervention |
| DM, OCT group | Experimental | Procedure: OCT-guided percutaneous coronary intervention |
| non DM, angio group | Active comparator | Procedure: percutaneous coronary intervention |
| non DM, OCT group | Experimental | Procedure: OCT-guided percutaneous coronary intervention |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Single lesion in a Single vessel
- Reference vessel diameter 2.5 - 3.5 mm
- Lesion length ≤ 34 mm and ≤ 34 mm stent length
- Stable angina requiring revascularization, patients with unstable angina
- The patient has no difficulty to enforce the follow-up angiography
Key exclusion criteria (14 listed)
- Lesions with graft vessel, thrombosis, restenosis, and bifurcation requiring 2 stents
- Reference vessel diameter < 2.5 mm or > 4.0mm
- Contraindication to anti-platelet agents
- Treated with any DES within 3 months at other vessel
- Creatinine level ≥ 2.0 mg/dL or ESRD
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 interventionthe traditional percutaneous coronary intervention by Resolute zotarolimus-eluting stent insertion | Procedure or surgery | DM, angio group |
| OCT-guided percutaneous coronary interventionthe percutaneous coronary intervention using optical coherence tomography by Resolute zotarolimus-eluting stent insertion | Procedure or surgery | DM, OCT group |
| percutaneous coronary interventionthe traditional percutaneous coronary intervention by Resolute zotarolimus-eluting stent insertion | Procedure or surgery | non DM, angio group |
| OCT-guided percutaneous coronary interventionthe percutaneous coronary intervention using optical coherence tomography by Resolute zotarolimus-eluting stent insertion | Procedure or surgery | non DM, OCT group |
Primary outcome
ratio of the stent strut
Time frame: Angiographic follow-up with OCT at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous coronary intervention and OCT-guided percutaneous coronary intervention in people with Coronary Artery Disease and Stable 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 6 inclusion and 14 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 5 Jun 2013. 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.
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 (82-2-2228-8460, mkhong61@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ratio of the stent strut (time frame: Angiographic follow-up with OCT at 6 months). 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 5 Jun 2013.