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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02014818
• Other study ID #: MECHANISM-Elective
• Status: Active, not recruiting
• Phase: N/A
• First received: December 12, 2013
• Last updated: October 17, 2017
• Start date: January 2014
• Est. completion date: December 31, 2018

Study information

• Verified date: October 2017
• Source: Kobe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 104
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 84 Years

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• CoCr-EES

Locations

Country	Name	City	State
Japan	Kobe University Graduate School of Medicine	Kobe

Sponsors (1)

Lead Sponsor	Collaborator
Kobe University

Country where clinical trial is conducted

Japan, 

Outcome

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