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

Not Applicable

• Conditions: Coronary Artery Disease
• Interventions: Device: CoCr-EES

• Registration Number: NCT02014818
• Lead Sponsor: Kobe University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-12
• Study First Submitted QC: 2013-12-12
• Study First Posted: 2013-12-18
• Study Start: 2014-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-17
• Last Update Posted: 2017-10-18
• Primary Completion: 2017-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 month OCT follow-up, CoCr-EES	CoCr-EES	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.
3 month OCT follow-up, CoCr-EES	CoCr-EES	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.

Primary Outcome Measures

Name	Time	Method
Rate of stent-strut coverage determined by OCT.	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

Secondary Outcome Measures

Name	Time	Method
Any TLR	1-year	Any target lesion revascularization at 1-year
CABG	1 year	Coronary artery bypass grafting
Any revascularization	1 year	Any revascularization including percutaneous intervention and surgical bypass grafting
Clinically-driven TLR	1 year	Clinically relevant revascularization, such as ischemia driven intervention
Angiographic binary restenosis	12 month	Angiographic restenosis defined as percentage of diameter stenosis more than 50% at target lesion
The percentage of stent strut coverage by OCT	12 month	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
Angiographic Quantitative analysis	12 month	* 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 ）
All-cause Death, Cardiac death, MI, Stroke, Major bleeding	1-year	All-cause Death, Cardiac death, MI, Stroke, Major bleeding
Any TVR	1 year	Any target vessel revascularization including both target lesion and remote lesion.
Patient-oriented composite	1 year	All-cause death, Any MI including non-target territory, Any repeat revascularization; ,Stroke
OCT endpoint	1-month or 3-month	* 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
Angiographic Qualitative analysis	12 month	* Peri-stent contrast stain (PSS); * Site and pattern of restenosis (based on Mehran clasification)

Trial Locations

Locations (1)

Kobe University Graduate School of Medicine; 🇯🇵 Kobe, Japan