NCT02517840

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
Last Updated

August 7, 2015

Status Verified

August 1, 2015

Enrollment Period

10.9 years

First QC Date

July 26, 2015

Last Update Submit

August 4, 2015

Conditions

Critical Limb Ischemia

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Limb salvage (LS)

    12 months after the procedure

  • Survival

    12 months after the procedure

Study Arms (1)

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

Eligibility Criteria

Age90 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Joaquin de Haro, M.D.

Study Record Dates

First Submitted

July 26, 2015

First Posted

August 7, 2015

Study Start

January 1, 2002

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

August 7, 2015

Record last verified: 2015-08