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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000007050
Enrollment
450
Registered
2012-01-11
Start date
2012-01-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Limb Ischemia

Interventions

None listed

Sponsors

SPINACH Study Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
amputation-free survival for patients undergoing revascularization procedures at 36 months

Countries

Japan

Contacts

Public ContactOsamu Iida

Kansai Rosai Hospital Cardiovascular Center

iida.osa@gmail.com09051586181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026