Coronary Artery DiseaseNCT02014818
Multicenter Comparison of Early and Late Vascular Responses to Everolimus-eluting Cobalt-CHromium Stent
A study testing CoCr-EES in people with Coronary Artery Disease, run by Kobe University at 1 site in Japan.
Trial summary
To treat patients with stable coronary artery disease, elective percutaneous coronary intervention (PCI) will be performed with the use of an everolimus-eluting cobalt- chromium stent (everolimus-eluting stent: EES, Xience Prime, Xpedition), which is the current standard drug-eluting stent (DES). Read more about this study
- Who is it for?
- Ages 20 to 84 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CoCr-EES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2014to 31 Dec 2018
- 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 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having at least one de novo lesion in a coronary artery in whom PCI with a DES is indicated
- Patients aged 20 to less than 85 years at the time of informed consent
- Patients who have provided informed consent written by themselves
- Patients who are able to undergo OCT examinations of the site of stent placement at 1 or 3 months and at 12 months
Who cannot join
- If it is judged difficult to perform clinical and angiographic follow-up at 12 months (considering the patient's remote place of residence, etc.)
- Patients with acute myocardial infarction (AMI)
- Patients in a state of shock
- Patients with cardiac failure
- Patients having a culprit lesion in the left main coronary artery trunk
- Patients having a lesion with a reference vessel diameter of less than 2.0 mm or 4.5 mm or larger by visual estimate
Show all 13Show fewer
- Patients having an in-stent restenosis lesion as the culprit lesion
- Patients having chronic renal failure with a serum creatinine level of 2.0 mg/dL or higher at a screening visit
- Patients on hemodialysis
- Cancer patients with a life expectancy of less than 2 years
- Patients who are scheduled to undergo elective surgery requiring discontinuation of antiplatelet therapy within the next 3 months
- Pregnant women or women expected to become pregnant
- Patients with a history of adverse reactions to aspirin or clopidogrel (however, it is acceptable to enroll patients in whom the safety of ticlopidine has been confirmed, even if they have a history of adverse reactions to clopidogrel)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Comparison of Early and Late Vascular Responses to Everolimus-eluting Cobalt-CHromium Stent and Platelet AggregatioN Studies In Patients With Stable Angina Managed as Elective Case : MECHANISM-Elective
To treat patients with stable coronary artery disease, elective percutaneous coronary intervention (PCI) will be performed with the use of an everolimus-eluting cobalt- chromium stent (everolimus-eluting stent: EES, Xience Prime, Xpedition), which is the current standard drug-eluting stent (DES). Vascular responses at the site of stent placement will be evaluated by optical coherence tomography (OCT) at 1 or 3 months and at 12 months after stent placement, along with observation of changes over time in the target vessel. The relationships between OCT findings and the time course of platelet aggregation and between OCT findings and the occurrence of major cardio- cerebrovascular events will also be elucidated.
- Conditions
- Coronary Artery Disease
- Being tested
- CoCr-EES
- 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.
CoCr-EESDevice
Also called XIENCE PRIME, XIENCE Xpedition
| Study group | Role | What they receive |
|---|---|---|
| 3 month OCT follow-up, CoCr-EES | Experimental | Elective PCI can be performed with the use of an EES. PCI in another vessel or follow-up angiography is expected to be performed 3 months after the index procedure. Receives: Device: CoCr-EES |
| 1 month OCT follow-up, CoCr-EES | Experimental | Elective PCI can be performed with the use of an EES. PCI in another vessel or follow-up angiography is expected to be performed 1 months after the index procedure. Receives: Device: CoCr-EES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of stent-strut coverage determined by OCT.
Rate of stent-strut coverage determined by OCT at 3 months after stent placement (To observe temporal course from the early stage, the rate of stent-strut coverage in the 1-month arm will also be evaluated in a complementary manner, separately from the 3-month arm.) To identify the factors defining the strut coverage at 1-month or 3-months, from OCT index, blood markers, platelet aggregation test immediately after stenting, the strut coverage of 1 to 3 months
Measured: 3 months
Secondary outcomes (12)
All-cause Death, Cardiac death, MI, Stroke, Major bleeding
All-cause Death, Cardiac death, MI, Stroke, Major bleeding
Measured: 1-year
Any TLR
Any target lesion revascularization at 1-year
Measured: 1-year
Clinically-driven TLR
Clinically relevant revascularization, such as ischemia driven intervention
Measured: 1 year
Any TVR
Any target vessel revascularization including both target lesion and remote lesion.
Measured: 1 year
CABG
Coronary artery bypass grafting
Measured: 1 year
Any revascularization
Any revascularization including percutaneous intervention and surgical bypass grafting
Measured: 1 year
Angiographic binary restenosis
Angiographic restenosis defined as percentage of diameter stenosis more than 50% at target lesion
Measured: 12 month
Patient-oriented composite
All-cause death, Any MI including non-target territory, Any repeat revascularization
,Stroke
Measured: 1 year
The percentage of stent strut coverage by OCT
Determination of factors associated with 12-month rate of stent-strut coverage on the basis of OCT findings, circulating biomarkers, and platelet aggregation test results immediately after stent placement
Measured: 12 month
OCT endpoint
- The percentage of stent strut malapposition
- The presence of Intra-stent thrombus
- Intra-stent thrombus area (Maximum site)
- Intra-stent thrombus length
- The number of Intra-stent thrombus
Measured: 1-month or 3-month
Angiographic Quantitative analysis
- In-segment late loss
- Minimal lumen diameter (MLD), reference vessel diameter (RVD), percent diameter stenosis (%DS)
- In-stent late loss
- Binary restenosis (In-stent, In-segment, Peri-stent)
- Angiographically detected stent fracture（based on Popma's classification ）
Measured: 12 month
Angiographic Qualitative analysis
- Peri-stent contrast stain (PSS)
- Site and pattern of restenosis (based on Mehran clasification)
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study startJan 2014
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2018 (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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study will comprise of 1 month follow-up and 3-month follow up arm, which enroll patients in a parallel manner.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (actual)
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, MD, PhD, Principal investigator, Kobe University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014818
- Sponsor's protocol ID
- MECHANISM-Elective
- Status last verified
- Oct 2017
- First submitted
- 12 Dec 2013
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Comparison of Early and Late Vascular Responses to Everolimus-eluting Cobalt-CHromium Stent and Platelet AggregatioN Studies In Patients With Stable Angina Managed as Elective Case : MECHANISM-Elective
- ClinicalTrials.gov ID
- NCT02014818
- Acronym / sponsor ID
- MECHANISM-Elective
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Kobe UniversityIndustry (pharma, biotech, devices)
- Study start
- Jan 2014 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 18 Dec 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.
To treat patients with stable coronary artery disease, elective percutaneous coronary intervention (PCI) will be performed with the use of an everolimus-eluting cobalt- chromium stent (everolimus-eluting stent: EES, Xience Prime, Xpedition), which is the current standard drug-eluting stent (DES). Vascular responses at the site of stent placement will be evaluated by optical coherence tomography (OCT) at 1 or 3 months and at 12 months after stent placement, along with observation of changes over time in the target vessel. The relationships between OCT findings and the time course of platelet aggregation and between OCT findings and the occurrence of major cardio- cerebrovascular events will also be elucidated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study will comprise of 1 month follow-up and 3-month follow up arm, which enroll patients in a parallel manner.
| Arm | Type | Receives |
|---|---|---|
| 3 month OCT follow-up, CoCr-EES | Experimental | Device: CoCr-EESElective PCI can be performed with the use of an EES. PCI in another vessel or follow-up angiography is expected to be performed 3 months after the index procedure. |
| 1 month OCT follow-up, CoCr-EES | Experimental | Device: CoCr-EESElective PCI can be performed with the use of an EES. PCI in another vessel or follow-up angiography is expected to be performed 1 months after the index procedure. |
Who may qualify
- Ages
- 20 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients having at least one de novo lesion in a coronary artery in whom PCI with a DES is indicated
- Patients aged 20 to less than 85 years at the time of informed consent
- Patients who have provided informed consent written by themselves
- Patients who are able to undergo OCT examinations of the site of stent placement at 1 or 3 months and at 12 months
Key exclusion criteria (13 listed)
- If it is judged difficult to perform clinical and angiographic follow-up at 12 months (considering the patient's remote place of residence, etc.)
- Patients with acute myocardial infarction (AMI)
- Patients in a state of shock
- Patients with cardiac failure
- Patients having a culprit lesion in the left main coronary artery trunk
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 |
|---|---|---|
| CoCr-EESAlso: XIENCE PRIME, XIENCE Xpedition | Device | 1 month OCT follow-up, CoCr-EES, 3 month OCT follow-up, CoCr-EES |
Primary outcome
Rate of stent-strut coverage determined by OCT.
Time frame: 3 months
Rate of stent-strut coverage determined by OCT at 3 months after stent placement (To observe temporal course from the early stage, the rate of stent-strut coverage in the 1-month arm will also be evaluated in a complementary manner, separately from the 3-month arm.) To identify the factors defining the strut coverage at 1-month or 3-months, from OCT index, blood markers, platelet aggregation test immediately after stenting, the strut coverage of 1 to 3 months
12 secondary outcomes
All-cause Death, Cardiac death, MI, Stroke, Major bleeding
Time frame: 1-year
Any TLR
Time frame: 1-year
Clinically-driven TLR
Time frame: 1 year
Any TVR
Time frame: 1 year
CABG
Time frame: 1 year
Any revascularization
Time frame: 1 year
Angiographic binary restenosis
Time frame: 12 month
Patient-oriented composite
Time frame: 1 year
The percentage of stent strut coverage by OCT
Time frame: 12 month
OCT endpoint
Time frame: 1-month or 3-month
Angiographic Quantitative analysis
Time frame: 12 month
Angiographic Qualitative analysis
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
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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, MD, PhD 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?
A study testing CoCr-EES in people with Coronary Artery 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 4 inclusion and 13 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 18 Oct 2017. 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?
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?
Rate of stent-strut coverage determined by OCT. (time frame: 3 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 18 Oct 2017.