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| Name | Class |
|---|---|
| C. R. Bard | INDUSTRY |
| Abbott Medical Devices | INDUSTRY |
| Boston Scientific Corporation | INDUSTRY |
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The PRIME Registry is a multi-center, observational study designed to evaluate immediate and long-term outcomes (36 months) of endovascular revascularization in patients with critical limb ischemia (CLI) and advanced peripheral artery disease (PAD).
The Peripheral RegIstry of Endovascular Clinical OutcoMEs (PRIME Registry) represents the collaborative effort among seven centers across the US with the goal of reaching 10 sites globally. PRIME explores all aspects of advanced peripheral arterial disease (PAD) and critical limb ischemia (CLI) care including the collection of comprehensive clinical, diagnostic, procedural, and follow-up data for three years following an index endovascular procedure. Data collection activities began in January of 2013 with the goal of collecting data on 1500 subjects. Analysis of this multi-site registry will produce generalizable findings that describe the clinical epidemiology and management practices of advanced PAD and CLI patients.
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| Measure | Description | Time Frame |
|---|---|---|
| Amputation free survival rates | At 36 month follow-up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Access site and procedural complications | At 36 month follow-up visit | |
| Target lesion revascularization | At 36 month follow-up visit | |
| Target vessel revascularization |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are to receive or have received lower extremity endovascular treatment for peripheral artery disease.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Health | Orlando | Florida | 32806 | United States | ||
| Prairie Heart |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 19, 2016 | Mar 9, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D016491 | Peripheral Vascular Diseases |
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| At 36 month follow-up visit |
| Procedural success | At 36 month follow-up visit |
| Springfield |
| Illinois |
| 62701 |
| United States |
| Metro Health Hospital | Wyoming | Michigan | 49519 | United States |
| Cox Health | Springfield | Missouri | 65807 | United States |
| Rex Healthcare | Raleigh | North Carolina | 27607 | United States |
| The Hospitals of Providence | El Paso | Texas | 79902 | United States |
| D002318 |
| Cardiovascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |