UMIN-CTR Clinical Trial

Public title

Serial Evaluation of Vascular Response at 1- and 9-month after Resolute Integrity Zotarolimus-Eluting Stent Implantation: Evaluation of Neointimal Coverage by Intravascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) -

Acronym

RI-ZES OCT Study

Scientific Title

Serial Evaluation of Vascular Response at 1- and 9-month after Resolute Integrity Zotarolimus-Eluting Stent Implantation: Evaluation of Neointimal Coverage by Intravascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) -

Scientific Title:Acronym

RI-ZES OCT Study

Region

Japan

Condition

Ischemic Heart Disease, Coronary Artery Disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate a possible reduction in the duration of post-procedural double antiplatelet therapy through observation of morphological changes in neointima at the site of stenting with the use of OCT at 1- and 9-month after Resolute Integrity zotarolimus-eluting stent implantation.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase IV

Primary outcomes

A two-dimensional cross-sectional analysis will be performed at 1-mm intervals (every 15frames) over the entire stent length at 1 and 9 months after stenting.

[Qualitative analysis]
- Number of stent struts analyzed
- Neointimal coverage (neointimal coverage in stent struts)
- Stent incomplete apposition (post-procedural incomplete stent apposition)
- Prolapse (plaque prolapse)
- Thrombus (thrombus around stent struts)
- Dissection (coronary dissection)

[Quantitative analysis]
- Neointimal thickness (NIT)

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

The study will enroll patients who are eligible for treatment with drug-eluting stents and who are scheduled for staged PCI. The Resolute Integrity stent will be implanted in lesions responsible for index PCI in 50 patients scheduled for staged PCI. This clinical study will be conducted with minimal exclusion criteria to reflect real-world clinical practice in the study.

Key exclusion criteria

- Unprotected LMT lesions
- Patients with cardiogenic shock
- Patients who have decompensated hypotension or are intubated, and those with cardiac failure requiring IABP
- Patients treated with debulking, such as Rotablator and DCA
- Patients with renal impairment (Cre ≥ 1.5)
- Proximal lesions within 10 mm from the coronary ostia (OCT not available)
- Patients from whom no written consent is obtained
- Other patients considered ineligible for this clinical study by the investigator

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Mitusru Munemasa

Organization

National Hospital Organization
Okayama Medical Center

Division name

Division of Cardiovascular Medicine

Zip code

Address

1711-1 Tamasu, Kita-ku, Okayama 701-1192, Japan

TEL

+81862949911

Email

munemasa@okayama3.hosp.go.jp

Name of contact person

1st name
Middle name
Last name	Mitusru Munemasa

Organization

National Hospital Organization Okayama Medical Center

Division name

Division of Cardiovascular Medicine

Zip code

Address

1711-1 Tamasu, Kuta-ku, Okayama 701-1192, Japan

TEL

+81862949911

Homepage URL

Email

munemasa@okayama3.hosp.go.jp

Institute

Division of Cardiovascular Medicine, National Hospital Organization Okayama Medical Center

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

10

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Enrolling by invitation

Date of protocol fixation

2013

Year

04

Month

01

Day

Date of IRB

Anticipated trial start date

2013

Year

08

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

OCT imaging analysis:
A two-dimensional cross-sectional analysis will be performed at 1-mm intervals (every 15 frames) over the entire stent length at 1 and 9 months after stenting.

Registered date

2013

Year

09

Month

27

Day

Last modified on

2013

Year

09

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013901