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OpenTrials
Completed

NCT Number: NCT02517840

Revascularization 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.

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Key information

Conditions

Critical Limb Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

90 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Limb salvage (LS)

    Time frame: 12 months after the procedure

    Percentage of revascularized limb which do no require major amputation at 12 months

  2. Survival

    Time frame: 12 months after the procedure

    Percentage of patients alive at 12 months

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Sponsors and collaborators

Lead sponsor

Hospital Universitario Getafe

Other

Registry information

Official study title

Revascularization Results in Nonagenarian Patients With Critical Lower Limb Ischaemia

Acronym: NONA-CLI

Important dates

Study start
2002
Primary completion
2012
Study completion
2012
First posted
Aug 7, 2015
Registry last updated
Aug 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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