UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Occlusive/Stenotic Peripheral artery REvascularization study
Title of the study (Brief title)	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	Takao Ohki
Organization	Jikei University School of Medicine
Division name	Vascular Surgery
Address	3-19-18 Nishi-shinbashi, Minato-ku, Tokyo, Japan
TEL	03-6742-8784
Email	Kazuo_Kawahara@terumo.co.jp

Public contact
Name of contact person	Kazuo Kawahara
Organization	Terumo Corporation
Division name	Clinical Development Department
Address	1500 Inokuchi, Nakai-machi, Ashigarakami-gun, Kanagawa, Japan
TEL	0465-81-4104
Homepage URL
Email	Kazuo_Kawahara@terumo.co.jp

Sponsor
Institute	Terumo Corporation
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 01 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003657