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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009909
Receipt No. R000011593
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.
Date of disclosure of the study information 2013/01/31
Last modified on 2013/01/30

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Basic information
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
Condition Coronary artery disease (CAD)
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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.





Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Department of Cardiovascular Internal Medicine, Kuki General Hospital
Institute
Department

Funding Source
Organization Kuki General Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 久喜総合病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
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
Other related information Prospective, Open-label, Single Center Registry

Management information
Registered date
2013 Year 01 Month 30 Day
Last modified on
2013 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011593

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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