UMIN-CTR Clinical Trial

Basic information
Public title	A Single Arm Clinical Trial in Japan for Reconstruction of Obstructive Lesions of the Superficial Femoral Artery or Proximal Popliteal Artery by Bard LifeStent
Acronym	RELIABLE
Scientific Title	A Single Arm Clinical Trial in Japan for Reconstruction of Obstructive Lesions of the Superficial Femoral Artery or Proximal Popliteal Artery by Bard LifeStent
Scientific Title:Acronym	RELIABLE
Region	Japan

Condition
Condition	Symptomatic occlusive disease of the peripheral arteries
Classification by specialty	Cardiology Vascular surgery Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to assess the safety and effectiveness of the MD-12-001 stent in the treatment of superficial femoral artery and proximal popliteal artery blockages in Japanese patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	The proportion of subjects who are free of target limb failure at 12-months post study procedure.
Key secondary outcomes	Primary patency, Secondary patency, Rutherford category assessment, ABI, Quality of life measurements, Major Adverse Events, all AEs and SAEs, TVR/TLR rates, and Freedom from Stent fracture rate

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	STENT
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	1. Rutherford Category 2-4 (mild intermittent claudication to ischemic pain at rest). 2. The target lesion(s) has evidence of narrowing or blockage and can be stented. 3. The total length of the lesion or series of lesions is estimated to be less than or equal to 150 mm.
Key exclusion criteria	1. The subject has concomitant renal failure with a creatinine of >2.5 mg/dl or having dialysis treatment. 2. Subject has a history of bypass surgery on the study vessel. 3. Subject has a history of MI or stroke within 6 months of study procedure.
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Masato Middle name Last name Nakamura
Organization	Ohashi Hospital of Toho University Medical Center
Division name	Cardiovascular internal medicine
Zip code	153-0044
Address	2-22-36, Ohashi, Meguro-ku, Tokyo
TEL	03-3468-1251
Email	medicon-clinicaltrial@crbard.com

Public contact
Name of contact person	1st name Soji Middle name Last name Iida
Organization	Medicon Inc.
Division name	Clinical Development
Zip code	541-0046
Address	2-5-8, Hiranomachi, Chuo-ku, Osaka
TEL	06-6203-6567
Homepage URL
Email	Soji.Iida@bd.com

Sponsor
Institute	Medicon Inc.
Institute
Department

Funding Source
Organization	Medicon Inc.
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	N/A
Address	N/A
Tel	N/A
Email	N/A

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	2012 Year 12 Month 15 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.jstage.jst.go.jp/article/avd/11/3/11_oa.18-00067/_article
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	2012 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date	2012 Year 12 Month 15 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	2012 Year 12 Month 14 Day
Last modified on	2021 Year 03 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011206