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

Primary Purpose

Coronary Artery Disease

Status

Unknown status

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

CoCr-EES

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

20 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Kobe University Graduate School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

3 month OCT follow-up, CoCr-EES

1 month OCT follow-up, CoCr-EES

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Any TLR

Any target lesion revascularization at 1-year

Clinically-driven TLR

Clinically relevant revascularization, such as ischemia driven intervention

Any TVR

Any target vessel revascularization including both target lesion and remote lesion.

CABG

Coronary artery bypass grafting

Any revascularization

Any revascularization including percutaneous intervention and surgical bypass grafting

Angiographic binary restenosis

Angiographic restenosis defined as percentage of diameter stenosis more than 50% at target lesion

Patient-oriented composite

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

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

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

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 ）

Angiographic Qualitative analysis

Peri-stent contrast stain (PSS) Site and pattern of restenosis (based on Mehran clasification)

Full Information

NCT ID

NCT02014818

First Posted

December 12, 2013

Last Updated

October 17, 2017

Sponsor

Kobe University

1. Study Identification

Unique Protocol Identification Number

NCT02014818

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 2014 (Actual)

Primary Completion Date

December 31, 2017 (Anticipated)

Study Completion Date

December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kobe University

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

Outcomes Assessor

Masking Description

All patients' information will be blinded to OCT image analyzers.

Allocation

Non-Randomized

Enrollment

104 (Actual)

8. Arms, Groups, and Interventions

Arm Title

3 month OCT follow-up, CoCr-EES

Arm Type

Experimental

Arm Description

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.

Arm Title

1 month OCT follow-up, CoCr-EES

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

CoCr-EES

Other Intervention Name(s)

XIENCE PRIME, XIENCE Xpedition

Primary Outcome Measure Information:

Title

Rate of stent-strut coverage determined by OCT.

Description

Time Frame

3 months

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

1-year

Title

Any TLR

Description

Any target lesion revascularization at 1-year

Time Frame

1-year

Title

Clinically-driven TLR

Description

Clinically relevant revascularization, such as ischemia driven intervention

Time Frame

1 year

Title

Any TVR

Description

Any target vessel revascularization including both target lesion and remote lesion.

Time Frame

1 year

Title

CABG

Description

Coronary artery bypass grafting

Time Frame

1 year

Title

Any revascularization

Description

Any revascularization including percutaneous intervention and surgical bypass grafting

Time Frame

1 year

Title

Angiographic binary restenosis

Description

Angiographic restenosis defined as percentage of diameter stenosis more than 50% at target lesion

Time Frame

12 month

Title

Patient-oriented composite

Description

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

Time Frame

1 year

Title

The percentage of stent strut coverage by OCT

Description

Time Frame

12 month

Title

OCT endpoint

Description

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

Time Frame

1-month or 3-month

Title

Angiographic Quantitative analysis

Description

Time Frame

12 month

Title

Angiographic Qualitative analysis

Description

Peri-stent contrast stain (PSS) Site and pattern of restenosis (based on Mehran clasification)

Time Frame

12 month

Other Pre-specified Outcome Measures:

Title

Platelet Aggregation Test

Description

(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.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

84 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Toshiro Shinke, MD, PhD

Organizational Affiliation

Kobe University Graduate School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kobe University Graduate School of Medicine

City

Kobe

ZIP/Postal Code

657-850

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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