Revascularization in Nonagenarian Patients With Critical Lower Limb Ischaemia

Critical Limb Ischemia Clinical Trial

— NONA-CLI  

Official title:

Revascularization Results in Nonagenarian Patients With Critical Lower Limb Ischaemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02517840
• Other study ID #: 15/199 ESTUDIO
• Status: Completed
• Phase: N/A
• First received: July 26, 2015
• Last updated: August 4, 2015
• Start date: January 2002
• Est. completion date: December 2012

Study information

• Verified date: August 2015
• Source: Hospital Universitario Getafe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 90 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Getafe

Outcome

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