UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007050
Receipt number R000008300
Scientific Title Surgical reconstruction versus Peripheral INtervention in pAtients with critical limb isCHemia, - prospective multicenter registry in Japan -
Date of disclosure of the study information 2012/01/11
Last modified on 2017/10/13 09:58:25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Surgical reconstruction versus Peripheral INtervention in pAtients with critical limb isCHemia,
- prospective multicenter registry in Japan -

Acronym

Surgical reconstruction versus Peripheral INtervention in pAtients with critical limb isCHemia (SPINACH Registry),
- prospective multicenter registry in Japan -

Scientific Title

Surgical reconstruction versus Peripheral INtervention in pAtients with critical limb isCHemia,
- prospective multicenter registry in Japan -

Scientific Title:Acronym

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

1st name
Middle name
Last name 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

Zip code


Address

Inabaso

TEL

0664161221

Email

iida.osa@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Osamu Iida

Organization

Kansai Rosai Hospital

Division name

Cardiovascular Center

Zip code


Address

Inabaso

TEL

09051586181

Homepage URL


Email

iida.osa@gmail.com


Sponsor or person

Institute

SPINACH Study Group

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Partially published


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

2011 Year 12 Month 27 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008300


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name