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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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Given the importance of understanding CLI patients' outcomes and existing gaps in knowledge, there is a pressing need to collect observational data on treatment patterns, adherence to performance measures, and outcomes that are relevant to patients and clinicians. To address this need, the current study will pilot test the research infrastructure and data elements needed to build a larger, national study collecting of the CLI population. It will also provide much-needed preliminary information to identify areas of action that can be targeted in quality improvement programs for this population. Most importantly, it will provide data on health status outcomes in patients with CLI, as a function of individual patient characteristics (demographics, socio-economic and clinical background) and the treatments that patients have undergone. The PORTRAIT-CLI study will also be well equipped to identify potential disparities in the provision of care and patients' outcomes as a function of patient's characteristics.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| care as usual | Other | The investigators will be following patients with critical limb ischemia and documenting the usual care that the participants receive. |
| Measure | Description | Time Frame |
|---|---|---|
| CLI-specific health status | Peripheral Artery Questionnaire-CLI version | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from major amputation or major reintervention | Freedom from major amputation or major peripheral vascular reintervention (surgical or angioplasty) | 12 months |
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Inclusion Criteria:
All race/ethnicity categories, English or Spanish speaking, men and women
Exclusion Criteria:
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Project coordinators at each recruitment site will have direct access to the PAD clinic schedules and will be prospectively screening from that list. A screening form with limited demographic information will be completed for all patients with a diagnosis of CLI supported by any of the following hemodynamic parameters (assessed pre-procedurally): Ankle pressure lower than 70 mmHg; Toe pressure lower than 50 mmHg or evidence of ischemia by transcutaneous oxygen measurement (tcpO2) <40 or a skin perfusion pressure (SPP) <40 or angiographic evidence of significant vascular disease.
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| Name | Affiliation | Role |
|---|---|---|
| Kim Smolderen, PhD | University of Missouri Kansas City; Saint Luke's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06520 | United States | ||
| University Hospitals Cleveland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20435259 | Background | Bradbury AW, Adam DJ, Bell J, Forbes JF, Fowkes FG, Gillespie I, Ruckley CV, Raab GM; BASIL trial Participants. Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: Analysis of amputation free and overall survival by treatment received. J Vasc Surg. 2010 May;51(5 Suppl):18S-31S. doi: 10.1016/j.jvs.2010.01.074. | |
| 14760329 |
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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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| Cleveland |
| Ohio |
| 44106 |
| United States |
| Spertus J, Jones P, Poler S, Rocha-Singh K. The peripheral artery questionnaire: a new disease-specific health status measure for patients with peripheral arterial disease. Am Heart J. 2004 Feb;147(2):301-8. doi: 10.1016/j.ahj.2003.08.001. |
| 16325694 | Result | Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, Fowkes FG, Gillepsie I, Ruckley CV, Raab G, Storkey H; BASIL trial participants. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet. 2005 Dec 3;366(9501):1925-34. doi: 10.1016/S0140-6736(05)67704-5. |
| 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 |