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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL141213-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with critical limb disease | This registry will collect data from participants with critical limb disease from Duke University and approximately 40 sites in North America. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
| Number of participants with amputation free survival as measured by patient report/verified by medical record review |
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Inclusion Criteria:
Exclusion Criteria:
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Patients presenting with critical limb ischemia Phase I: While the BEST-CLI Trial is actively enrolling, the BEST-Registry will only enroll patients who first screen fail from BEST-CLI.
Phase II: After BEST-CLI officially finishes enrollment, screen failure for BEST-CLI will no longer be required for enrollment into the BEST-Registry
1200 patients, across approximately 40 sites participating in BEST-CLI clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Manesh Patel, MD | Duke University | Principal Investigator |
| Sreekanth Vemulapalli, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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Interviews completed at 6 months with participants that note no hospitalization for amputation and verified by medical records |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 12 months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |