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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003222
Receipt No. R000003902
Scientific Title Assessment of Neointimal Stent Strut Coverage and Endothelial Function After Second Generation Drug-Eluting Stent Systems
Date of disclosure of the study information 2010/03/01
Last modified on 2018/12/01

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Basic information
Public title Assessment of Neointimal Stent Strut Coverage and Endothelial Function After Second Generation Drug-Eluting Stent Systems
Acronym Assessment of Stent Strut Coverage and Endothelial Function After Drug-Eluting Stents (ASSESS)
Scientific Title Assessment of Neointimal Stent Strut Coverage and Endothelial Function After Second Generation Drug-Eluting Stent Systems
Scientific Title:Acronym Assessment of Stent Strut Coverage and Endothelial Function After Drug-Eluting Stents (ASSESS)
Region
Japan

Condition
Condition Stable angina pectoris
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare coronary endothelium function in patients with a zotarolimus-eluting versus a sirolimus-eluting or a everolimus-eluting stents with optical coherence tomography, vasoconstrictioin in response to acetylcholine, and coronary biomarker level.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. To compare coronary endothelial function after primary angioplasty
2. To compare the presence of neointimal stent strut coverage via optical coherence tomography
3. To compare the serum biomarker levels measured in coronary artery blood
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Zotarolimus-eluting stent
Interventions/Control_2 Sirolimus-eluting stent
Interventions/Control_3 Everolimus-eluring stent
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
25 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Significant coronary de novo lesion (70% by quantitative angiographic analysis)
2. Patients with stable angina pectoris considered for coronary intervention
3. Reference vessel diameter of 2.5 to 3.5 mm by operator assessment
Key exclusion criteria 1. Contraindication to anti-platelet agents
2. Ostial lesion within 5mm from ostium
3. Different DES in other vessel simultaneously
4. Creatinine level more than 2.5mg/dl
5. Left main stenosis more than 50%
6. Vein graft lesion
7. Triple vessel disease with stenosis more than 50% in 3 epicardial coronary arteries
8. Life expectancy 1 year
9. Reference vessel diameter <2.5mm or >4.0mm by visual
10. Long lesion that require more than three stents
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Fujii
Organization Hyogo College of Medicine
Division name Cardiovascular Division
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya-city, Hyogo 6638501 JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kenichi Fujii
Organization Hyogo College of Medicine
Division name Cardiovascular Division
Zip code
Address
TEL 0798-45-6553
Homepage URL
Email

Sponsor
Institute Cardiovascular Division, Hyogo College of Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine
Organization
Division
Category of Funding Organization Self funding
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 YES
Study ID_1 NCT01073111
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 01 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 Completed
Date of protocol fixation
2010 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 02 Month 21 Day
Last modified on
2018 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003902

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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