UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003291 |
|---|---|
| Receipt number | R000003657 |
| Scientific Title | Occlusive/Stenotic Peripheral artery REvascularization study |
| Date of disclosure of the study information | 2010/03/05 |
| Last modified on | 2016/09/08 09:35:14 |
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Basic information
Public title
Occlusive/Stenotic Peripheral artery REvascularization study
Acronym
OSPREY
Scientific Title
Occlusive/Stenotic Peripheral artery REvascularization study
Scientific Title:Acronym
OSPREY
Region
| Japan | North America |
Condition
Condition
Peripheral arterial disease of lower extremities by a stenotic or occlusive de novo lesion at SFA/PA
Classification by specialty
| Cardiology | Vascular surgery | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to confirm the safety and efficacy of the study device in a stenotic or occlusive de novo lesion at SFA/PA against PTA treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Non-TLF rate at 12 months
Key secondary outcomes
Delivery success, Lesion success, Patency rate, Acute Gain, ABI, Rutherford classification, QoL, Adverse events, Serious adverse events, Major adverse events, Device failures/Malfunctions including stent fracture, Complications relate to investigational devices
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Stent
Interventions/Control_2
PTA
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
(1) 20 years of age and older, (on the signature date of the consent form)
(2) Informed consent
(3) Rutherford 2 to 4
(4) ABI <0.9 or abnormal ABI at practice
(5) RVD: 4.0-7.0 mm
(6) length: 40-150 mm
Key exclusion criteria
(1) Terminal illness in whom life expectancy is expected to be less than 3 years.
(2) Patients who are participating in other clinical study of medical device or pharmaceuticals within 3months before registration.
(3) Already participated in this study in the past.
(4) Previously received a bypass surgery, stent implantation or any surgery at SFA or distally.
(5) Scheduled for a staged procedure to treat lesions within the aorta or ipsilateral run-off vessels after enrollment.
(6) Allergy or experienced an anaphylactic symptom to components of the study device.
(7) Acute or chronic renal failure (serum creatinine 2.0mg/dL or more)
(8) Advanced calcification or excessive tortuosity at target lesion
(9) Patients who are pregnant or breast-feeding, or in whom these conditions are possible.
(10) Patients who were judged to be inappropriate for participation in the study due to severe or uncontrolled systemic disease of any condition by the principal investigators/investigators.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Ohki |
Organization
Jikei University School of Medicine
Division name
Vascular Surgery
Zip code
Address
3-19-18 Nishi-shinbashi, Minato-ku, Tokyo, Japan
TEL
03-6742-8784
Kazuo_Kawahara@terumo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Kawahara |
Organization
Terumo Corporation
Division name
Clinical Development Department
Zip code
Address
1500 Inokuchi, Nakai-machi, Ashigarakami-gun, Kanagawa, Japan
TEL
0465-81-4104
Homepage URL
Kazuo_Kawahara@terumo.co.jp
Sponsor or person
Institute
Terumo Corporation
Institute
Department
Personal name
Funding Source
Organization
Terumo Corporation
Organization
Division
Category of Funding Organization
Profit organization
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
| 2010 | Year | 03 | Month | 05 | 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 | 01 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | 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 | 03 | Month | 05 | Day |
Last modified on
| 2016 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003657
