Clinical trial NCT02014818: Multicenter Comparison of Early and Late Vascular Responses to Everolimus-eluting Cobalt-CHromium Stent
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Kobe University
Sponsor class: INDUSTRY
First posted: 2013-12-18
Enrollment: 104
Sex: ALL
Minimum age (years): 20
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will comprise of 1 month follow-up and 3-month follow up arm, which enroll patients in a parallel manner.
Primary purpose: TREATMENT

Brief 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). 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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)

Primary outcomes:
measure: Rate of stent-strut coverage determined by OCT.
timeFrame: 3 months
Secondary outcomes:
measure: All-cause Death, Cardiac death, MI, Stroke, Major bleeding
timeFrame: 1-year
measure: Any TLR
timeFrame: 1-year
measure: Clinically-driven TLR
timeFrame: 1 year
measure: Any TVR
timeFrame: 1 year
measure: CABG
timeFrame: 1 year
measure: Any revascularization
timeFrame: 1 year
measure: Angiographic binary restenosis
timeFrame: 12 month
measure: Patient-oriented composite
timeFrame: 1 year
measure: The percentage of stent strut coverage by OCT
timeFrame: 12 month
measure: OCT endpoint
timeFrame: 1-month or 3-month
measure: Angiographic Quantitative analysis
timeFrame: 12 month
measure: Angiographic Qualitative analysis
timeFrame: 12 month
Other outcomes:
measure: Platelet Aggregation Test
timeFrame: At the time of OCT follow-up (1 month or 3 month) and 12 month
Locations:
city: Kobe
country: Japan
facility: Kobe University Graduate School of Medicine
Study officials:
affiliation: Kobe University Graduate School of Medicine
name: Toshiro Shinke, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: