Multicenter Comparison of Early and Late Vascular Responses to Everolimus-eluting Cobalt-CHromium Stent

Kobe University

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Device: CoCr-EES

Study type: Interventional

Funder types: Industry

Identifiers

NCT02014818

MECHANISM-Elective

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 20 to 84 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

3 month OCT follow-up, CoCr-EES

Experimental group

Description:

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.

Treatment:

Device: CoCr-EES

1 month OCT follow-up, CoCr-EES

Experimental group

Description:

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.

Treatment:

Device: CoCr-EES