Coronary Heart DiseaseHEALNCT01689688
Healing Response to Everolimus-eluting Stent Implantation; Serial Assessment With opticaL Coherence Tomography
An observational study of Coronary Heart Disease, run by Kobe University at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate serial changes of neointimal coverage after everolimus-eluting stent implantation at 3-, 6- and 12-months by OCT examination. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Heart Disease
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2012to Oct 2015
- Phase
- Observational
- 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
Study population: Patients who are percutaenous coronary intervention and stenting and eligible to receive dual antiplatelet therapy at least more than 6 month.
Who may be able to join
- Older than 20 years old.
- Indication of PCI.
- To agree to review and record all the clinical course in this research protocol.
- The patient who are eligible to receive dual antiplatelet therapy at least more than 6 month.
- Informed concent with the document signed by the patients.
- The patient have to correspond to all the above items at the time of registration.
Who cannot join
- The patient who died during the research
- The patient with Stent thrombosis during the research.
- Previous history of pancytopenia, liver function, renal dysfunction, hypersensitive history of the drug.
- Low ejection fraction (LVEF<=30%), an impaired liver function, and renal dysfunction (eGFR<=30)
- The patient excluded from a safety of a thiazolidine derivative.
- lesion exclusion criteria
Show all 9Show fewer
- left main artery
- severe calcification
- stent restenosis
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Kobe University Graduate School of Medicine
Kobe, Hyōgo
Toshiro Shinke, MD, PhD, +81.78.382.5846, shinke@med.kobe-u.ac.jp
Toshiro Shinke, MD, PhD
About this study
The purpose of this study is to evaluate serial changes of neointimal coverage after everolimus-eluting stent implantation at 3-, 6- and 12-months by OCT examination.
Read the detailed description
Late and very late stent thrombosis is current main issue after introduction of drug-eluting stents .Possible causes of these stent thromboses include thrombus formation resulting from delayed neointimal coverage, spasms occurring at the distal end of the stent implantation site, positive remodeling of coronary arteries caused by local immune reaction to paclitaxel or rapamycin, and vascular endothelial damage induced by the polymer. For BMS, neointimal coverage begins within the first one month after stent implantation and almost completes in three months. For DES, sirolimus eluting stents (SES) for example, neointimal coverage is markedly delayed after stent implantation and the exposed stent struts may be largely attributable to the occurrence of late stent thrombosis.
On the other hand, everolimus eluting stents (EES), which have a thinner stent strut layer and improved polymer biocompatibility, it has been reported that earlier and more normal neointimal coverage can be achieved compared with other first-generation DESs, SES and paclitaxel eluting stents (PES). These findings suggest that coverage with vascular endothelium differs among different DES platforms. Optical coherence tomography (OCT) has a resolution of 15 to 20 μm, which is approximately 10 times higher than that of intravascular ultrasound (IVUS). It is therefore necessary to use OCT to accurately evaluate cross-sectional images of the stent struts covered with vascular endothelium. However, no studies have reported the results of continuous observation and evaluation of EES covered with endothelium.
Therefore, the investigators investigate time course of neointimal coverage of EES through detailed evaluation by OCT of neointimal coverage at 3, 6, and 12 months after stent implantation.
- Conditions
- Coronary Heart Disease
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EES-XIENCE V | Groups who were treated with XIENCE V® everolimus eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of neointimal coverage
The primary endpoint is to evaluate the neointimal coverage of XIENCE everolimus eluting stent (EES) in 12 month after stent implantation by Optical coherence tomography
Measured: 12 months
Secondary outcomes (2)
The percentage of neointimal coverage
Measured: 3 months
The percentage of neointimal coverage
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2013 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kobe University
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Toshiro Shinke, MD, PhD, Kobe University
- Investigators
- Toshiro Shinke, Principal investigator, Kobe University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689688
- Sponsor's protocol ID
- KobeU-001
- Other IDs
- R000008722
- Acronym
- HEAL
- Status last verified
- Sep 2013
- First submitted
- 7 Sep 2012
- Last updated
- 9 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Response to Everolimus-eluting Stent Implantation; Serial Assessment With opticaL Coherence Tomography
- ClinicalTrials.gov ID
- NCT01689688
- Acronym / sponsor ID
- HEAL / KobeU-001
- Conditions
- Coronary Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kobe UniversityIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 21 Sep 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 evaluate serial changes of neointimal coverage after everolimus-eluting stent implantation at 3-, 6- and 12-months by OCT examination.
Detailed description
Late and very late stent thrombosis is current main issue after introduction of drug-eluting stents .Possible causes of these stent thromboses include thrombus formation resulting from delayed neointimal coverage, spasms occurring at the distal end of the stent implantation site, positive remodeling of coronary arteries caused by local immune reaction to paclitaxel or rapamycin, and vascular endothelial damage induced by the polymer. For BMS, neointimal coverage begins within the first one month after stent implantation and almost completes in three months. For DES, sirolimus eluting stents (SES) for example, neointimal coverage is markedly delayed after stent implantation and the exposed stent struts may be largely attributable to the occurrence of late stent thrombosis.
On the other hand, everolimus eluting stents (EES), which have a thinner stent strut layer and improved polymer biocompatibility, it has been reported that earlier and more normal neointimal coverage can be achieved compared with other first-generation DESs, SES and paclitaxel eluting stents (PES). These findings suggest that coverage with vascular endothelium differs among different DES platforms. Optical coherence tomography (OCT) has a resolution of 15 to 20 μm, which is approximately 10 times higher than that of intravascular ultrasound (IVUS). It is therefore necessary to use OCT to accurately evaluate cross-sectional images of the stent struts covered with vascular endothelium. However, no studies have reported the results of continuous observation and evaluation of EES covered with endothelium.
Therefore, the investigators investigate time course of neointimal coverage of EES through detailed evaluation by OCT of neointimal coverage at 3, 6, and 12 months after stent implantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EES-XIENCE V | – | –Groups who were treated with XIENCE V® everolimus eluting stent |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are percutaenous coronary intervention and stenting and eligible to receive dual antiplatelet therapy at least more than 6 month.
Key inclusion criteria (6 listed)
- Older than 20 years old.
- Indication of PCI.
- To agree to review and record all the clinical course in this research protocol.
- The patient who are eligible to receive dual antiplatelet therapy at least more than 6 month.
- Informed concent with the document signed by the patients.
Key exclusion criteria (9 listed)
- The patient who died during the research
- The patient with Stent thrombosis during the research.
- Previous history of pancytopenia, liver function, renal dysfunction, hypersensitive history of the drug.
- Low ejection fraction (LVEF<=30%), an impaired liver function, and renal dysfunction (eGFR<=30)
- The patient excluded from a safety of a thiazolidine derivative.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The percentage of neointimal coverage
Time frame: 12 months
The primary endpoint is to evaluate the neointimal coverage of XIENCE everolimus eluting stent (EES) in 12 month after stent implantation by Optical coherence tomography
2 secondary outcomes
The percentage of neointimal coverage
Time frame: 3 months
The percentage of neointimal coverage
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 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.
Toshiro Shinke principal investigator
Kobe University Graduate School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease, run by Kobe University at 1 site in Japan.
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 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: status not confirmed, as of the sponsor's last update on 9 Sep 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 Japan. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of neointimal coverage (time frame: 12 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 9 Sep 2013.