For subjects with critical limb ischemia, identify patient, physician/hospital, and geographic factors associated with variations in treatment strategies; compare treatments and outcomes, including quality of life, cost and cost effectiveness, at 6, 12 months.
The study will be a prospective multicenter registry evaluating the real world therapeutic strategies, clinical outcomes, and costs associated with patients presenting with critical limb ischemia. Population: Patients over age 18 presenting with critical limb ischemia After initial enrollment at 40 study sites throughout the US. participants will complete follow-up 6 months and 12 months via call center telephone calls. The study plan calls for enrollment of approximately 1,200 participants throughout the US that will then have 12 month followup that includes collection of medications, hospitalizations for collection of events.Additionally, the BEST-CLI trial will be gathering quality of life data and cost data using similar instruments, thus providing an opportunity for comparison between cost and quality of life analyses in a clinical trial versus in a real-world registry and collection of Quality of Life using validated instruments: EQ-5D, VASQOL, SF-12.and bill review to determine economic impact of disease.
Study Type
OBSERVATIONAL
Enrollment
1,009
Duke University Medical Center
Durham, North Carolina, United States
Percentage of participants with major adverse limb events (MALE) as measured by patient reports (verified by medical records)
Number of participants in the registry with major limb events as reported by participants and confirmed by medical records
Time frame: 6 months
Percentage of participants with major adverse limb events (MALE) as measured by patient reports (verified by medical records)
Number of participants in the registry with major limb events as reported by participants and confirmed by medical records
Time frame: 12 months
Number of participants that died within 30 days of index procedure
Collect composite of MALE or perioperative death within 30 days of index procedure using patient/proxy information qualified by medical records.
Time frame: 30 days
Number of participants with amputation free survival as measured by patient report/verified by medical record review
Interviews completed at 6 months with participants that note no hospitalization for amputation and verified by medical records
Time frame: 6 months
Number of participants with amputation free survival as measured by patient report/verified by medical record review
Interviews completed at 12 months with participants that note no hospitalization for amputation and verified by medical records
Time frame: 12 months
Number of participants that did not have secondary interventions in index leg as measured by patient report/verified by medical record review
At 6 month visit, the number of participants that did not report additional procedures such as surgery or angiography.in the affected leg
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Time frame: 6 months
Number of participants that did not have secondary interventions in index leg as measured by patient report/verified by medical record review
At 12 month visit, the number of participants that did not report additional procedures such as surgery or angiography.in the affected leg
Time frame: 12 months
Number of interventions per limb as measured by patient report/verified by medical record review
Interventions consist of need to be hospitalized for a form of revascularization
Time frame: 6 months
Number of interventions per limb as measured by patient report/verified by medical record review
Interventions consist of need to be hospitalized for a form of revascularization
Time frame: 12 months
Number of participants that did not have limb revascularization failure as measured by patient report/verified by medical record review
Limb revascularization failure is loss of circulation to the limb that has procedural revascularization previously performed that is non functioning
Time frame: 6 months
Number of participants that did not have limb revascularization failure as measured by patient report/verified by medical record review
Limb revascularization failure is loss of circulation to the limb that has procedural revascularization previously performed that is non functioning
Time frame: 12 months
Number of participants who did not have a myocardial infarction as measured by patient report/verified by medical record review
Number of participants that answered no to the question "Was your hospitalization for a Heart Attack(MI) at 6 months verified by medical record.
Time frame: 6 months
Number of participants who did not have a myocardial infarction as measured by patient report/verified by medical record review
Number of participants that answered no to the question "Was your hospitalization for a Heart Attack(MI) at 12 months verified by medical record.
Time frame: 12 months
Number of participants who did not have a stroke while in the registry as measured by patient report/verified by medical record review
Stroke is inclusive of a cerebral vascular including a ischemic, hemorrhagic or a TIA event.
Time frame: 6 months
Number of participants who did not have a stroke while in the registry as measured by patient report/verified by medical record review
Stroke is inclusive of a cerebral vascular including a ischemic, hemorhagic or a TIA event.
Time frame: 12 months
Number of participants that did not have a periprocedural (30 day) major adverse cardiac events as measured by patient report/verified by medical record review
Events that occur during a revascularization procedure including cardiovascular events such as Myocardial Infarction and stoke.
Time frame: 6 months
Quality of life as measure by the validated QOL tool called the EuroQol that will be administered throughout the study
The EuroQol is a 6 question validated instrument that asks questions regarding mobility, self care, usual activities, pain/discomfort and anxiety and depression. I also includes a 0-100 scale regarding participants assessment of health.
Time frame: Baseline
Quality of life as measure by the validated QOL tool called the EuroQol that will be administered throughout the study
The EuroQol is a 6 question validated instrument that asks questions regarding mobility, self care, usual activities, pain/discomfort and anxiety and depression. I also includes a 0-100 scale regarding participants assessment of health.
Time frame: 6 month
Quality of life as measure by the validated QOL tool (EuroQol) that will be administered throughout the study
The EuroQol is a 6 question validated instrument that asks questions regarding mobility, self care, usual activities, pain/discomfort and anxiety and depression with a range of 5 answers. I also includes a 0-100 scale regarding participants assessment of health.
Time frame: 12 month
Quality of life as measured by the the SF-12 instrument that will be administered throughout the study
The SF-12 Health Survey is a shorter version of the SF-36 Health Survey that uses 12 questions to measure functional health and well-being from the patient's point of view
Time frame: Baseline
Quality of life as measured by the the SF-12 instrument that will be administered throughout the study
The SF-12 Health Survey is a shorter version of the SF-36 Health Survey that uses 12 questions to measure functional health and well-being from the patient's point of view
Time frame: 6 months
Quality of life as measured by the the SF-12 instrument that will be administered throughout the study
The SF-12 Health Survey is a shorter version of the SF-36 Health Survey that uses 12 questions to measure functional health and well-being from the patient's point of view
Time frame: 12 months