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Clinical Trials/NCT02517840
NCT02517840
Completed
N/A

Revascularization Results in Nonagenarian Patients With Critical Lower Limb Ischaemia

Hospital Universitario Getafe0 sites53 target enrollmentJanuary 2002

Overview

Phase
N/A
Intervention
Not specified
Conditions
Critical Limb Ischemia
Sponsor
Hospital Universitario Getafe
Enrollment
53
Primary Endpoint
Incidence at 30 days of major adverse cardiovascular events (MACE)
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2002
End Date
December 2012
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hospital Universitario Getafe
Responsible Party
Principal Investigator
Principal Investigator

Joaquin de Haro, M.D.

Joaquin de Haro, M.D.

Hospital Universitario Getafe

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Incidence at 30 days of major adverse cardiovascular events (MACE)

Time Frame: 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)

Time Frame: 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)

Time Frame: 30 days after the procedure

Incidence at 30 days of limb major amputations (MA), in percentage.

Secondary Outcomes

  • Limb salvage (LS)(12 months after the procedure)
  • Survival(12 months after the procedure)

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