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

NCT02014818 | Unknown DMC

• 1 other identifier: MECHANISM-Elective
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

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

  1-year

• Any TLR

  1-year

• Clinically-driven TLR

  1 year

• Any TVR

  1 year

• CABG

  1 year

Other Outcomes (1)

• Platelet Aggregation Test

  At the time of OCT follow-up (1 month or 3 month) and 12 month

Study Arms (2)

3 month OCT follow-up, CoCr-EES

EXPERIMENTAL

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

1 month OCT follow-up, CoCr-EES

EXPERIMENTAL

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

Interventions

CoCr-EES DEVICE

Also known as: XIENCE PRIME, XIENCE Xpedition

1 month OCT follow-up, CoCr-EES; 3 month OCT follow-up, CoCr-EES

Eligibility Criteria

• Age: 20 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kobe University: lead

Study Sites (1)

Kobe University Graduate School of Medicine

Kobe, 657-850, Japan

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Toshiro Shinke, MD, PhD

  Kobe University Graduate School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All patients' information will be blinded to OCT image analyzers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study will comprise of 1 month follow-up and 3-month follow up arm, which enroll patients in a parallel manner.

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: December 18, 2013
• Study Start: January 1, 2014
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2018
• Last Updated: October 18, 2017

Record last verified: 2017-10

Locations

JP (1)