UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010164 |
|---|---|
| Receipt number | R000011898 |
| Scientific Title | A Prospective Multicenter Post-Approval Study to Evaluate the Long-Term Efficacy and Safety of the Resolute Integrity in the Japanese All-Comers Patients with Coronary Artery Disease |
| Date of disclosure of the study information | 2013/03/20 |
| Last modified on | 2016/03/25 16:26:04 |
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Basic information
Public title
A Prospective Multicenter Post-Approval Study to Evaluate the Long-Term Efficacy and Safety of the Resolute Integrity in the Japanese All-Comers Patients with Coronary Artery Disease
Acronym
PROPEL STUDY
Scientific Title
A Prospective Multicenter Post-Approval Study to Evaluate the Long-Term Efficacy and Safety of the Resolute Integrity in the Japanese All-Comers Patients with Coronary Artery Disease
Scientific Title:Acronym
PROPEL STUDY
Region
| Japan |
Condition
Condition
Coronary Artery Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main objective of the present clinical study is to assess the product performance of the Resolute Integrity Stent System as well as its long-term clinical safety and efficacy in the Japanese all-comers population with coronary artery disease who require treatment with drug-eluting stent.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
To assess the long-term safety and efficacy of Resolute Integrity stent system by assessing noninferiority of the primary endpoint against the Xience V arm from the RESOLUTE All-Comers clinical study.
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Routine Angiographic FU cohort.
The routine angiographic FU cohort comprises patients who underwent clinical FU at 9,12, and 24 months after index PCI those who undergo angiographic FU at 10 months after index PCI.
Interventions/Control_2
Clinical FU cohort.
The clinical FU cohort comprises among patients who underwent clinical FU at 9, 12, and 24 months after index PCI those who arbitrarily underwent angiographic FU at 22 months after index PCI and those who did not undergo angiographic follow-up at all during the entire study period.
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
| 85 | years-old | > |
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 FU procedures specified in the protocol for this clinical study.
6.Patients in whom more than 50% occlusion or stenosis is visually confirmed in a native coronary artery with a diameter of 2.5 mm – 3.5 mm on coronary angiography and that has an anatomical structure suitable for PCI using RI-ZES.
Key exclusion criteria
1.Patients aged 85 years or older.
2.Patients with cardiogenic shock.
3.Patients who are pregnant or possibly pregnant.
4.Patients who cannot comply with the antiplatelet therapy specified for this clinical study.
5.Patients scheduled to undergo elective surgery within 6 months post-index PCI.
6.Patients with a history of allergic reaction or hypersensitivity to zotarolimus, sirolimus, tacrolimus, everolimus, or other analogues or derivatives.
7.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.
8.Patients with hypersensitivity to cobalt, nickel, chrome, molybdenum, coated polymer (e.g., BioLinx) contained in the materials of the study device or in whom these substances are specifically contraindicated.
9.Patients who are currently participating in a clinical study of another drug or medical device and in whom assessment of the primary endpoint of that study has not been completed or clinically interferes with the endpoints of this clinical study.
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Nakamura |
Organization
Toho UNiversity Medical Center Ohashi Hospital
Division name
Department of Cardiology
Zip code
Address
2-17-6, Ohashi, Megro-ku, Tokyo 153-8515, Japan
TEL
+81-3-3468-1251
info@propel-study.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Soiken Inc.
Division name
PROPEL STUDY Support Center
Zip code
Address
4F, NBF Ogawacho Building, 1-3-1, Kanda Ogawacho, Chiyoda-ku, Tokyo 101-0052, Japan
TEL
+81-3-3295-1350
Homepage URL
http://propel-study.com/
info@propel-study.com
Sponsor or person
Institute
Associations for Establishment of Evidence in Interventions
Institute
Department
Personal name
Funding Source
Organization
Medtronic Japan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2013 | Year | 03 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 02 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 04 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 04 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 05 | Day |
Last modified on
| 2016 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011898
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