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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: CoCr-EES

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Kobe, Japan, 657-850
    • Kobe University Graduate School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 84 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 3 month OCT follow-up, 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.	Device: CoCr-EES; Other Names: XIENCE PRIME; XIENCE Xpedition
EXPERIMENTAL: 1 month OCT follow-up, 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.	Device: CoCr-EES; Other Names: XIENCE PRIME; XIENCE Xpedition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet Aggregation Test	(1) at the time of PCI, (2) at the time of OCT at 1 or 3 months after PCI, (3) at 12-month follow-up, and (4) at the time of occurrence of a cardio-cerebrovascular event.	At the time of OCT follow-up (1 month or 3 month) and 12 month

Collaborators and Investigators

• Sponsor: Kobe University
• Investigators: Principal Investigator: Toshiro Shinke, MD, PhD, Kobe University Graduate School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2014
• Primary Completion (ANTICIPATED): December 31, 2017
• Study Completion (ANTICIPATED): December 31, 2018

Study Registration Dates

• First Submitted: December 12, 2013
• First Submitted That Met QC Criteria: December 12, 2013
• First Posted (ESTIMATE): December 18, 2013

Study Record Updates

• Last Update Posted (ACTUAL): October 18, 2017
• Last Update Submitted That Met QC Criteria: October 17, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: MECHANISM-Elective