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

N/AUnknownNCT02014818

Kobe University104 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

104

Conditions

Coronary Artery Disease

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 84 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

Time frame: 3 months

Secondary Outcomes

All-cause Death, Cardiac death, MI, Stroke, Major bleeding

Time frame: 1-year

Any TLR

Any target lesion revascularization at 1-year

Time frame: 1-year

Clinically-driven TLR

Clinically relevant revascularization, such as ischemia driven intervention

Time frame: 1 year

Any TVR

Any target vessel revascularization including both target lesion and remote lesion.

Time frame: 1 year

CABG

Coronary artery bypass grafting

Time frame: 1 year

Any revascularization

Any revascularization including percutaneous intervention and surgical bypass grafting

Time frame: 1 year

Angiographic binary restenosis

Angiographic restenosis defined as percentage of diameter stenosis more than 50% at target lesion

Time frame: 12 month

Patient-oriented composite

All-cause death, Any MI including non-target territory, Any repeat revascularization ,Stroke

Time frame: 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

Time frame: 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

Time frame: 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 ）

Time frame: 12 month

Angiographic Qualitative analysis

* Peri-stent contrast stain (PSS) * Site and pattern of restenosis (based on Mehran clasification)

Time frame: 12 month

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes