UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021055 |
|---|---|
| Receipt number | R000024145 |
| Scientific Title | Calcified Atherosclerotic Lesion in Coronary Arteries treated by Cobalt Chromium Everolimus-eluting Stent System |
| Date of disclosure of the study information | 2016/02/20 |
| Last modified on | 2016/02/16 17:16:15 |
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Basic information
Public title
Calcified Atherosclerotic Lesion in Coronary Arteries treated by Cobalt Chromium Everolimus-eluting Stent System
Acronym
CALC-ACCESS
Scientific Title
Calcified Atherosclerotic Lesion in Coronary Arteries treated by Cobalt Chromium Everolimus-eluting Stent System
Scientific Title:Acronym
CALC-ACCESS
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate procedural and short- and long-term clinical effectiveness and safety of the Xience drug eluting stent (DES) in treatment of calcified lesions of the coronary artery in daily clinical practice in Japan
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Target lesion failure (TLF) within 1 year after Xience implantation. TLF include cardiac death, target vessel related MI, clinically-driven TLR [that is with ischemic
symptoms or a positive functional ischemia study or DS>70% or higher confirmed by quantitative coronary angiography (QCA)].
Key secondary outcomes
a) Procedural success rate (technical success rate and clinical success rate) of Xience implantation
b) Incidence of MI (Q wave MI and non-Q wave MI) at 12-month and 36 months follow-up.
c) Target vessel failure (TVF) at 12months and months follow-up.
d) Major adverse cardiac event (MACE) (cardiac death, MI, and TVF) at 12 months and 36 months.
e) Stent thrombosis: Definite or Probable stent thrombosis according to the academic research consortium (ARC) definition.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Cobalt Chromium Everolimus-eluting Stent System(CoCr-EES)
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
a) Patients who is 20 years of age or older at informed consent
b) Patients who submit signed consent by themselves or their legally acceptable representative
c) Patients who are suitable for treatment with PCI
d) Patients who have calcification in stenotic lesions confirmed by CAG and are considered to be suitable for DES stenting as the best option by a treating physician
e) Patients for whom Xience stent is considered suitable for treatment
f) Patients with the visually measured maximum vessel diameter of =or< 2.5, =or>4.0 mm in the planned location for device implantation in the target lesion
g) Patients who are considered to be possible to continue dual antiplatelet therapy for at least 6 months after Xience implantation
Key exclusion criteria
h) Patients who, apart from this study, have received or plan to receive DES other than everolimus-eluting stent in the target vessel
i) Patients with acute myocardial infarction (MI)
j) Patients who have experienced acute MI within 7 days before planned PCI
k) Patients who are participating another on-going registry or clinical study or receiving treatment that may has an impact on endpoints of this research
l) Female patients who are found to be possibly pregnant by a pregnancy test or plan to be pregnant during this study
m) Patients with a past history of allergy to everolimus, polymer, or metal
n) Patients with a past history of allergy to antiplatelet drugs.
o) Patients who have been diagnosed as renal insufficiency.
p) Patients with renal insufficiency (serum creatinine of 3.0 mg/dL or higher) or on hemodialysis
q) Patients who had been diagnosed as having malignant tumor(s) in past 5 years
r) A target lesion is an in-stent restenosis lesion
s) A target lesion is in a graft
t) Patients who have 2 indepeneded lesions in same vessel
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenya Nasu, Yuji Oikawa |
Organization
Toyohashi Heart Center, The Cardiovascular Institute
Division name
Cardiology
Zip code
Address
21-1 O-yama cho, Toyohashi, Aichi, 441853
TEL
0532-37-3377
yuyatomoya@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenya Nasu |
Organization
Toyohashi Heart Center
Division name
Cardiology
Zip code
Address
21-1 O-yama cho, Toyohashi, Aichi, 4418530, Japan
TEL
0532-37-3377
Homepage URL
yuyatomoya@gmail.com
Sponsor or person
Institute
Nonprofit Organization Nakanihon PCI society
Institute
Department
Personal name
Funding Source
Organization
Nonprofit Organization Nakanihon PCI society
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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 20 | 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
| 2016 | Year | 02 | Month | 16 | Day |
Last modified on
| 2016 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024145
