UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of Neointimal Stent Strut Coverage and Endothelial Function After Second Generation Drug-Eluting Stent Systems
Title of the study (Brief title)	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	Kenichi Fujii
Organization	Hyogo College of Medicine
Division name	Cardiovascular Division
Address	1-1 Mukogawa-cho, Nishinomiya-city, Hyogo 6638501 JAPAN
TEL
Email

Public contact
Name of contact person	Kenichi Fujii
Organization	Hyogo College of Medicine
Division name	Cardiovascular Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 02 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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