UMIN-CTR Clinical Trial

Public title

Prospective, Single center, Registry to Evaluate the Long-term Clinical Safety and Efficacy of the Resolute Integrity drug eluting stent in an all-comers population.

Acronym

Resolute Integrity-KUKI Registry

Scientific Title

Prospective, Single center, Registry to Evaluate the Long-term Clinical Safety and Efficacy of the Resolute Integrity drug eluting stent in an all-comers population.

Scientific Title:Acronym

Resolute Integrity-KUKI Registry

Region

Japan

Condition

Coronary artery disease (CAD)

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assess the clinical long-term safety and efficacy of the Resolute Integrity Zotarolimus-Eluting Stent in real-world Japanese patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Primary outcomes

Cumulative incidence of target lesion failure at 12 months after index PCI.

Key secondary outcomes

1. Cumulative incidence of stent fracture by angiographic assessment at 12, 24 and 36 months after index PCI.

2. Cumulative incidence of stent thrombosis at 12, 24 and 36 months after index PCI.

3. Cumulative incidence of peri-stent contrast staining by angiographic assessment at 12, 24 and 36 months after index PCI.

4. Cumulative incidence of target vessel failure at 12, 24 and 36 months after index PCI in DM patients.

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patients aged 20 years or older

2.Patients with symptomatic coronary disease

3.Patients with a clinical indication for PCI and stenting of at least one coronary lesion, visually confirmed on coronary angiography

4.Patients who give informed consent to participate in this clinical study and sign the informed consent form approved by the institutional review board of each study site before the index PCI

5.Patients who agree to undergo all clinical follow-up procedures specified in the protocol for this clinical study

Key exclusion criteria

1.Patients with cardiogenic shock

2.Patients who are pregnant or possibly pregnant

3.Patients who cannot comply with the antiplatelet therapy specified for this clinical study

4.Patients scheduled to undergo elective surgery within 6 months post-index PCI

5.Patients with a history of allergic reaction or hypersensitivity to zotarolimus, sirolimus, tacrolimus, everolimus, or other analogues or derivatives

6.Patients with an allergic reaction to antiplatelet or anticoagulant drugs, such as heparin, aspirin, ticlopidine, or clopidogrel, or contrast agents, or those who cannot tolerate these substances and to whom appropriate treatments cannot be given

7. Patient who underwent stent treatment with BMS in other lesions within 6 months prior to the conduct of index PCI of the target vessel

Target sample size

1000

Name of lead principal investigator

1st name
Middle name
Last name	Yasutaka Shirasaki

Organization

Kuki General Hospital

Division name

Cardiovascular Internal Medicine

Zip code

Address

418-1 Kamihayami, Kuki City, Saitama

TEL

0480-26-0033

Email

Name of contact person

1st name
Middle name
Last name	Yasutaka Shirasaki

Organization

Kuki General Hospital

Division name

Cardiovascular Internal Medicine

Zip code

Address

418-1 Kamihayami, Kuki City, Saitama

TEL

0480-26-0033

Homepage URL

Email

Institute

Department of Cardiovascular Internal Medicine, Kuki General Hospital

Institute

Department

Personal name

Organization

Kuki General Hospital

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

久喜総合病院（埼玉県）

Date of disclosure of the study information

2013

Year

01

Month

31

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

Open public recruiting

Date of protocol fixation

2012

Year

09

Month

30

Day

Date of IRB

Anticipated trial start date

2012

Year

10

Month

09

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Prospective, Open-label, Single Center Registry

Registered date

2013

Year

01

Month

30

Day

Last modified on

2013

Year

01

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011593