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

• ClinicalTrials.gov Identifier: NCT02014818
• Recruitment Status: Unknown
• First Posted: December 18, 2013
• Last Update Posted: October 18, 2017
• Sponsor: Kobe University
• Information provided by (Responsible Party): Toshiro Shinke, MD, PhD, Kobe University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Device: CoCr-EES	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 104 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This study will comprise of 1 month follow-up and 3-month follow up arm, which enroll patients in a parallel manner.
• Masking: Single (Outcomes Assessor)
• Masking Description: All patients' information will be blinded to OCT image analyzers.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: January 2014
• Estimated Primary Completion Date: December 31, 2017
• Estimated Study Completion Date: December 31, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Rate of stent-strut coverage determined by OCT. [ Time Frame: 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 :

1. All-cause Death, Cardiac death, MI, Stroke, Major bleeding [ Time Frame: 1-year ]
   All-cause Death, Cardiac death, MI, Stroke, Major bleeding
2. Any TLR [ Time Frame: 1-year ]
   Any target lesion revascularization at 1-year
3. Clinically-driven TLR [ Time Frame: 1 year ]
   Clinically relevant revascularization, such as ischemia driven intervention
4. Any TVR [ Time Frame: 1 year ]
   Any target vessel revascularization including both target lesion and remote lesion.
5. CABG [ Time Frame: 1 year ]
   Coronary artery bypass grafting
6. Any revascularization [ Time Frame: 1 year ]
   Any revascularization including percutaneous intervention and surgical bypass grafting
7. Angiographic binary restenosis [ Time Frame: 12 month ]
   Angiographic restenosis defined as percentage of diameter stenosis more than 50% at target lesion
8. Patient-oriented composite [ Time Frame: 1 year ]

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

   ,Stroke

9. The percentage of stent strut coverage by OCT [ Time Frame: 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
10. OCT endpoint [ Time Frame: 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
11. Angiographic Quantitative analysis [ Time Frame: 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 ）
12. Angiographic Qualitative analysis [ Time Frame: 12 month ]
    • Peri-stent contrast stain (PSS)
    • Site and pattern of restenosis (based on Mehran clasification)

Other Outcome Measures:

1. Platelet Aggregation Test [ Time Frame: At the time of OCT follow-up (1 month or 3 month) and 12 month ]
   (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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 84 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Locations

Japan

Kobe University Graduate School of Medicine

Kobe, Japan, 657-850

Sponsors and Collaborators

Kobe University

Investigators

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

More Information

• Responsible Party: Toshiro Shinke, MD, PhD, Associate Professor, Kobe University
• ClinicalTrials.gov Identifier: NCT02014818 History of Changes
• Other Study ID Numbers: MECHANISM-Elective
• First Posted: December 18, 2013
• Last Update Posted: October 18, 2017
• Last Verified: October 2017

Additional relevant MeSH terms:

Heart Diseases; Cobalt; Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chromium; Everolimus; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Trace Elements; Micronutrients; Nutrients; Growth Substances