Coronary Artery DiseaseASSESSNCT01073111
Assessment of Stent Strut Coverage and Endothelial Function After Drug-Eluting Stents
A study testing zotarolimus-eluting stent (ENDEAVOR®), sirolimus-eluting stents (CYPHER SELECT® PLUS) and everolimus-eluting stents (PROMUS®) in people with Coronary Artery Disease and Atherosclerosis, run by Hyogo Medical University at 1 site in Japan.
Trial summary
The purpose of this study is to compare coronary endothelium function in patients with a zotarolimus-eluting versus a sirolimus-eluting or a everolimus-eluting stents with optical coherence tomography, vasoconstriction in response to acetylcholine, and coronary biomarker level. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Atherosclerosis
- What is being tested?
- zotarolimus-eluting stent (ENDEAVOR®), sirolimus-eluting stents (CYPHER SELECT® PLUS) and everolimus-eluting stents (PROMUS®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2010to Feb 2017
- 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Significant coronary de novo lesion (> 70% by quantitative angiographic analysis)
- Patients with stable or acute coronary syndrome considered for coronary revascularization
- Reference vessel diameter of 2.5 to 3.5 mm by operator assessment
Who cannot join
- Contraindication to anti-platelet agents
- Ostial lesion within 5 mm from ostium
- Different DES in other vessel simultaneously
- Creatinine level 2.5 mg/dL
- Left main stenosis more than 50%.
- vein graft lesion
Show all 10Show fewer
- Triple vessel disease with stenosis more than 50% in 3 epicardial coronary arteries
- Life expectancy 1 year
- Reference vessel < 2.5 mm or > 4.0 mm diameter by visual
- Long lesion that require more than three stents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Neointimal Stent Strut Coverage and Endothelial Function After Second Generation Drug-Eluting Stent Systems
The purpose of this study is to compare coronary endothelium function in patients with a zotarolimus-eluting versus a sirolimus-eluting or a everolimus-eluting stents with optical coherence tomography, vasoconstriction in response to acetylcholine, and coronary biomarker level.
- Conditions
- Coronary Artery Disease, Atherosclerosis
- Being tested
- zotarolimus-eluting stent (ENDEAVOR®), sirolimus-eluting stents (CYPHER SELECT® PLUS), everolimus-eluting stents (PROMUS®)
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zotarolimus-eluting stent (ENDEAVOR®)Device
zotarolimus-eluting stent
sirolimus-eluting stents (CYPHER SELECT® PLUS)Device
sirolimus-eluting stents
everolimus-eluting stents (PROMUS®)Device
everolimus-eluting stents
| Study group | Role | What they receive |
|---|---|---|
| zotarolimus-eluting stents (ENDEAVOR®) | Active comparator | Not described Receives: Device: zotarolimus-eluting stent (ENDEAVOR®) |
| sirolimus-eluting stents (CYPHER SELECT® PLUS) | Active comparator | Not described Receives: Device: sirolimus-eluting stents (CYPHER SELECT® PLUS) |
| everolimus-eluting stents (PROMUS®) | Active comparator | Not described Receives: Device: everolimus-eluting stents (PROMUS®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare coronary endothelial function after primary angioplasty.
Measured: 6 months and 12 months
To compare the presence of neointimal stent strut coverage via optical coherence tomography.
Measured: 6 months and 12 months
To compare the serum biomarker levels measured in coronary artery blood.
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2011
- Study completionFeb 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hyogo Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenichi Fujii, Hyogo Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073111
- Sponsor's protocol ID
- ASSESS
- Acronym
- ASSESS
- Status last verified
- Feb 2017
- First submitted
- 22 Feb 2010
- Last updated
- 3 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Neointimal Stent Strut Coverage and Endothelial Function After Second Generation Drug-Eluting Stent Systems
- ClinicalTrials.gov ID
- NCT01073111
- Acronym / sponsor ID
- ASSESS / ASSESS
- Conditions
- Coronary Artery Disease, Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hyogo Medical UniversityUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 23 Feb 2010 (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 coronary endothelium function in patients with a zotarolimus-eluting versus a sirolimus-eluting or a everolimus-eluting stents with optical coherence tomography, vasoconstriction in response to acetylcholine, and coronary biomarker level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| zotarolimus-eluting stents (ENDEAVOR®) | Active comparator | Device: zotarolimus-eluting stent (ENDEAVOR®) |
| sirolimus-eluting stents (CYPHER SELECT® PLUS) | Active comparator | Device: sirolimus-eluting stents (CYPHER SELECT® PLUS) |
| everolimus-eluting stents (PROMUS®) | Active comparator | Device: everolimus-eluting stents (PROMUS®) |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Significant coronary de novo lesion (> 70% by quantitative angiographic analysis)
- Patients with stable or acute coronary syndrome considered for coronary revascularization
- Reference vessel diameter of 2.5 to 3.5 mm by operator assessment
Key exclusion criteria (10 listed)
- Contraindication to anti-platelet agents
- Ostial lesion within 5 mm from ostium
- Different DES in other vessel simultaneously
- Creatinine level 2.5 mg/dL
- Left main stenosis more than 50%.
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 |
|---|---|---|
| zotarolimus-eluting stent (ENDEAVOR®)zotarolimus-eluting stent | Device | zotarolimus-eluting stents (ENDEAVOR®) |
| sirolimus-eluting stents (CYPHER SELECT® PLUS)sirolimus-eluting stents | Device | sirolimus-eluting stents (CYPHER SELECT® PLUS) |
| everolimus-eluting stents (PROMUS®)everolimus-eluting stents | Device | everolimus-eluting stents (PROMUS®) |
Primary outcome
To compare coronary endothelial function after primary angioplasty.
Time frame: 6 months and 12 months
To compare the presence of neointimal stent strut coverage via optical coherence tomography.
Time frame: 6 months and 12 months
To compare the serum biomarker levels measured in coronary artery blood.
Time frame: 6 months and 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zotarolimus-eluting stent (ENDEAVOR®), sirolimus-eluting stents (CYPHER SELECT® PLUS) and everolimus-eluting stents (PROMUS®) in people with Coronary Artery Disease and Atherosclerosis, run by Hyogo Medical 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 3 inclusion and 10 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: withdrawn, as of the sponsor's last update on 3 Aug 2018. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
To compare coronary endothelial function after primary angioplasty. (time frame: 6 months and 12 months). The study lists 3 primary outcomes in all. 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 3 Aug 2018.