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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010164
Receipt No. 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

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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 &#8211; 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
Email 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/
Email info@propel-study.com

Sponsor
Institute Associations for Establishment of Evidence in Interventions
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011898

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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