UMIN-CTR Clinical Trial

Basic information
Public title	Clinical Follow-Up After Vascular Therapy in Patients with Critical Limb Ischemia
Acronym	Clinical Follow-Up After Vascular Therapy in Patients with Critical Limb Ischemia
Scientific Title	Clinical Follow-Up After Vascular Therapy in Patients with Critical Limb Ischemia
Scientific Title:Acronym	Clinical Follow-Up After Vascular Therapy in Patients with Critical Limb Ischemia
Region	Japan

Condition
Condition	Peripheral Artery Disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Long-term follow-up study in CLI patients after vascular treatment
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Freedom from all-cause death
Key secondary outcomes	Major adverse cardiovascular event (death, myocardial infarction and stroke), target vessel revascularization, limb amputation

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Medical refractory patients against conventional therapy, whom were performed any kinds of vascular therapy (bypass graft surgery, catheter intervention, and vascular regenerative therapy).
Key exclusion criteria	1) no evidence of angiological stenosis confirmed by angiography, 2) history of vascular surgery (within 30 days), 3) presence of any malignant disease or history of its treatment within 5 years, 4) untreated proliferative diabetic retinopathy, 5) smoker unable to quit smoking, 6) drug addiction of any kind (including alcohol), 7) evidence of active viral infection, 8) infectious osteomyelitis, and 9) complication of any serious disease affecting the patient's general condition
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Gen Middle name Last name Takagi
Organization	Nippon Medical School
Division name	Department of Cardiovascular Medicine
Zip code	113 8603
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL	03-3822-2131
Email	gen52@nms.ac.jp

Public contact
1st name of contact person	1st name Gen Middle name Last name Takagi
Organization	Nippon Medical School
Division name	Department of Cardiovascular Medicine
Zip code	113 8603
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL	03-3822-2131
Homepage URL
Email	gen52@nms.ac.jp

Sponsor
Institute	Department of Cardiovascular Medicine, Nippon Medical School
Institute
Department

Funding Source
Organization	JSPS-Kakenhi
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB-Nippon Medical School
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo
Tel	03-3822-2131
Email	clinicaltrial@nms.ac.jp

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	日本医科大学付属病院(Nippon Medical School, University Hospital)

Other administrative information
Date of disclosure of the study information	2010 Year 08 Month 28 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	No longer recruiting
Date of protocol fixation	2010 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date	2010 Year 08 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	Baseline clinical characteristics and procedural data were collected from hospital charts or databases. Clinical follow-up data were obtained from either a review of the hospital records or telephone contacts with the patients or their referring physicians.

Management information
Registered date	2010 Year 08 Month 27 Day
Last modified on	2019 Year 03 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004917