Critical Limb IschemiaNONA-CLINCT02517840
Revascularization in Nonagenarian Patients With Critical Lower Limb Ischaemia
An observational study of Critical Limb Ischemia, run by Hospital Universitario Getafe.
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… Read more about this study
- Who is it for?
- Ages 90 years and older
- Conditions the study is for
- Critical Limb Ischemia
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- Jan 2002to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 90 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients suffering from Critical Limb Ischemia aged 90 year-old or above
Who may be able to join
- Patients suffering from Critical Limb Ischemia aged 90 year-old or above
Who cannot join
- -
About this study
Official title: 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.
- Conditions
- Critical Limb Ischemia
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 30 days after the procedure
Secondary outcomes (2)
Limb salvage (LS)
Percentage of revascularized limb which do no require major amputation at 12 months
Measured: 12 months after the procedure
Survival
Percentage of patients alive at 12 months
Measured: 12 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startJan 2002
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Getafe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joaquin de Haro, M.D., Hospital Universitario Getafe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517840
- Sponsor's protocol ID
- 15/199 ESTUDIO
- Acronym
- NONA-CLI
- Status last verified
- Aug 2015
- First submitted
- 26 Jul 2015
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revascularization Results in Nonagenarian Patients With Critical Lower Limb Ischaemia
- ClinicalTrials.gov ID
- NCT02517840
- Acronym / sponsor ID
- NONA-CLI / 15/199 ESTUDIO
- Conditions
- Critical Limb Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Hospital Universitario GetafeUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 90 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients suffering from Critical Limb Ischemia aged 90 year-old or above
Key inclusion criteria (1 listed)
- Patients suffering from Critical Limb Ischemia aged 90 year-old or above
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Limb salvage (LS)
Time frame: 12 months after the procedure
Survival
Time frame: 12 months after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Limb Ischemia, run by Hospital Universitario Getafe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence at 30 days of major adverse cardiovascular events (MACE) (time frame: 30 days after the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2015.