UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003222 |
|---|---|
| Receipt number | 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 21:00:08 |
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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
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
Sponsor or person
Institute
Cardiovascular Division, Hyogo College of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003902
