UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Surgical reconstruction versus Peripheral INtervention in pAtients with critical limb isCHemia, - prospective multicenter registry in Japan -
Title of the study (Brief title)	Surgical reconstruction versus Peripheral INtervention in pAtients with critical limb isCHemia (SPINACH Registry), - prospective multicenter registry in Japan -
Region	Japan

Condition
Condition	Critical Limb Ischemia
Classification by specialty	Cardiology Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of efficacy and safety of bypass surgery versus endovascular therapy in patients with critical limb ischemia
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	amputation-free survival for patients undergoing revascularization procedures at 36 months
Key secondary outcomes

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	a. Patients who can provide an informed consent and are aged 20 years or older when providing the consent b. CLI has been diagnosed, and revascularization is indicated. c. Follow-up for three years is considered feasible.
Key exclusion criteria	d. Patients who may not allow long-term follow-up (bedridden person, dementia etc.) e. Affected limbs in which ischemic ulcer or gangrene widely spreads beyond the ankle region f. Affected limbs which are to undergo revascularization as pre-treatment of the major lower limb amputation g. Affected limbs which have undergone revascularization after CLI symptoms first appeared
Target sample size	450

Research contact person
Name of lead principal investigator	1) Nobuyoshi Azuma, 2) Osamu Iida
Organization	1) Asahikawa Medical University 2) Kansai Rosai Hospital
Division name	1) First Department of Surgery 2) cardiovascular Center
Address	Inabaso
TEL	0664161221
Email	iida.osa@gmail.com

Public contact
Name of contact person	Osamu Iida
Organization	Kansai Rosai Hospital
Division name	Cardiovascular Center
Address	Inabaso
TEL	09051586181
Homepage URL
Email	iida.osa@gmail.com

Sponsor
Institute	SPINACH Study Group
Institute
Department

Funding Source
Organization	SPINACH Study Group
Organization
Division
Category of Funding Organization	Self funding
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	関西ろうさい病院（兵庫県）、菊名記念病院（神奈川県）、京都大学医学部附属病院（京都府）、小倉記念病院（福岡県）、済生会横浜市東部病院（神奈川県）新古賀病院（福岡県）、信州大学医学部附属病院（長野県）、仙台厚生病院（宮城県）、東邦大学医療センター大橋病院（東京都）、兵庫医科大学病院（兵庫県）、福岡赤十字病院（福岡県）、愛知医科大学病院（愛知県）旭川医科大学病院（北海道）国立病院機構金沢医療センター（石川県）、埼玉医科大学総合医療センター（埼玉県）、新須磨病院（兵庫県）、新日鐵八幡病院（福岡県）、東京医大八王子医療センター （東京都）、名古屋大学医学部附属病院（愛知県）、名寄市立総合病院（北海道）、松山赤十字病院（愛媛県）

Other administrative information
Date of disclosure of the study information	2012 Year 01 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 12 Month 27 Day
Anticipated trial start date	2012 Year 01 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	Partially published
URL releasing results
Results
Other related information	Of patients with CLI, Patients who have undergone revascularization or an attempt thereof are registered, and follow-up survey is conducted 1, 3, 6, 12, 24 and 36 months after the procedure.

Management information
Registered date	2012 Year 01 Month 11 Day
Last modified on	2017 Year 10 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008300