Revascularization in Nonagenarian Patients With Critical Lower Limb Ischaemia

Revascularization Results in Nonagenarian Patients With Critical Lower Limb Ischaemia

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02517840

Acronym

NONA-CLI

Enrollment

Registered

2015-08-07

Start date

2002-01-31

Completion date

2012-12-31

Last updated

2015-08-07

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

Conditions

Critical Limb Ischemia

Brief summary

The rise in life expectancy implies an increased number of nonagenarian patients who need evaluation for critical lower limb ischaemia (CLI). The study goal is to evaluate whether revascularization techniques in these patients fulfill a set of security and efficacy criteria generated from surgical results in a validated historical cohort.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

90 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients suffering from Critical Limb Ischemia aged 90 year-old or above

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Incidence at 30 days of major adverse cardiovascular events (MACE)	30 days after the procedure	Incidence at 30 days of major adverse cardiovascular events (MACE): stroke, myocardial infarction or death by cardiovascular cause, in percentage.
Incidence at 30 days of major adverse limb events (MALE)	30 days after the procedure	Incidence at 30 days of major adverse limb events (MALE): limb acute ischemia or amputation, in percentage.
Incidence at 30 days of limb major amputations (MA)	30 days after the procedure	Incidence at 30 days of limb major amputations (MA), in percentage.

Secondary

Measure	Time frame	Description
Limb salvage (LS)	12 months after the procedure	Percentage of revascularized limb which do no require major amputation at 12 months
Survival	12 months after the procedure	Percentage of patients alive at 12 months

Outcome results