Revascularization in Nonagenarian Patients With Critical Lower Limb Ischaemia (NONA-CLI)

Revascularization Results in Nonagenarian Patients With Critical Lower Limb Ischaemia

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.

Study Overview

• Status: Completed
• Conditions: Critical Limb Ischemia

• Study Type: Observational
• Enrollment (Actual): 53

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 90 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Nonagenarian CLI; Patients suffering from Critical Limb Ischemia aged 90 year-old or above who undergo limb revascularization by means of open surgery or endovascular revascularization

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Universitario Getafe

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: July 26, 2015
• First Submitted That Met QC Criteria: August 4, 2015
• First Posted (Estimate): August 7, 2015

Study Record Updates

• Last Update Posted (Estimate): August 7, 2015
• Last Update Submitted That Met QC Criteria: August 4, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: 15/199 ESTUDIO