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| Dataset wrap |
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| Rowcaps |
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| Row 1: | Shows the graft vessel was built on the LEFT FEMORO-POPLITEAL ARTERY. |
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| Row 2: | Shows the bypass graft type was venous cadaveric graft, which is composed of a artery harvested from a cadaver. |
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| Rows 3-4: | Show the graft anastomoses (connections) to the LEFT FEMORO-POPLITEAL ARTERY were on the LEFT COMMON FEMORAL ARTERY and LEFT POPLITEAL ARTERY. |
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | FASEQ | FATEST | FAOBJ | FACAT | FAORRES | VISITNUM | VISIT | TUDTC |
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| 1 | TUDY01 | FA | 40912 | 1 | Graft Construction Location | CORONARY ARTERY BYPASS GRAFT | PRIOR SURGERY | LEFT FEMORO-POPLITEAL ARTERY | 1 | SCREEN | 2007-01-01 |
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| 2 | TUDY01 | FA | 40912 | 2 | Bypass Graft Type | CORONARY ARTERY BYPASS GRAFT | PRIOR SURGERY | CADAVERIC GRAFT, VENOUS | 1 | SCREEN | 2007-01-01 |
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| 3 | TUDY01 | FA | 40912 | 3 | Graft Anastomosis (connection) Location | CORONARY ARTERY BYPASS GRAFT | PRIOR SURGERY | LEFT COMMON FEMORAL ARTERY | 1 | SCREEN | 2007-01-01 |
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| 4 | TUDY01 | FA | 40912 | 4 | Graft Anastomosis (connection) Location | CORONARY ARTERY BYPASS GRAFT | PRIOR SURGERY | LEFT POPLITEAL ARTERY | 1 | SCREEN | 2007-01-01 |
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Two separate lesions are located in the left leg of the subject, one (Lesion 1) in the native FEMORO-POPLITEAL PERIPHERAL ARTERY, the other (lesion 2) in the FEMORO-POPLITEAL graft. Lesion 1 is considered as non-target, lesion 2 is considered as target.
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| Rowcaps |
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| Row 1: | Shows one or more lesions have been identified in the lower limb region. |
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| Row 2: | shows the native vessel that contains a lesion is the left femoro-popliteal peripheral artery. |
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| Row 3: | Shows the lesion is found in the left popliteal artery above the knee. |
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| Row 4: | Shows the graft vessel that contains a lesion is the femoro-popliteal graft. |
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| Row 5: | Shows the lesion is located in the proximal anastomosis (connection) of the graft. |
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| Row 6: | Shows the limb that contains lesion is the left leg. |
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| Row 7: | Shows the lesion in the native vessel is considered as non-target. In the context of clinical investigation, any vessel or bypass graft not treated or for which treatment was not attempted with a device or technique being studied. This includes vessels treated with (nonstudy) vascular intervention and vessels managed medically. (ACC/AHA Clinical Data Standards 2014) |
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| Row 8: | Shows the lesion is considered as non-target. In the context of clinical investigation, any lesion not treated or for which treatment was not attempted with the device or technique being studied. This includes lesions treated with (nonstudy) PVI and lesions managed medically. (ACC/AHA Clinical Data Standards 2014) |
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| Row 9: | Shows the graft vessel is considered as target. In the context of clinical investigation, a target vessel is any noncardiac or nonintracranial blood vessel that contains the target lesion treated with the study device. |
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| Row 10: | Shows the lesion in the graft vessel is considered target. In the context of clinical investigation, any lesion treated or for which treatment was attempted with a device or technique being studied. (ACC/AHA Clinical Data Standards 2014) |
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| Row 11: | Shows the left leg is considered as target. The target limb is the extremity that contains the target lesion and all the native vessels upstream and downstream from it, including side branches. (Jordan: this data element is really terrible, because a graft lesion can be a target lesion if deemed treatable by PVI, so the limb that contains a graft lesion would also be considered as a target limb. I hate common data elements, i think this test should just be removed from the dataset because the original source is really terrible.) |
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TULNKID | TUTEST | TULOC | TULAT | TULOCDTL | TUORRES | TUSTRESC | TURESLOC
| TURESLAT | TURLOCDL | TUMETHOD | TUEVEL | VISITNUM | VISIT | TUDTC |
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| 1 | TUDY01 | TU | 40912 | 1 |
| Lesion Indicator | LOWER LIMB REGION |
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| Y | Y |
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| PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | BASELINE | 2007-02-01 |
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| 2 | TUDY01 | TU | 40912 | 2 | Vessel 1-Lesion 1 | Native Vessel with Lesion Location Identification | LOWER LIMB REGION |
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| LOCATED | LOCATED | FEMORO-POPLITEAL PERIPHERAL ARTERY | LEFT |
| PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | BASELINE | 2007-02-01 |
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| 3 | TUDY01 | TU | 40912 | 3 | Lesion 1 | Lesion Location Identification | LOWER LIMB REGION |
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| LOCATED | LOCATED | POPLITEAL ARTERY | LEFT | ABOVE KNEE | PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | BASELINE | 2007-02-01 |
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| 4 | TUDY01 | TU | 40912 | 4 | Graft Vessel 1-Lesion 2 | Graft Vessel with Lesion Location Identification | LOWER LIMB REGION |
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| LOCATED | LOCATED | LEFT FEMORO-POPLITEAL GRAFT |
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| PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | BASELINE | 2007-02-01 |
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| 5 | TUDY01 | TU | 40912 | 5 | Lesion 2 | Graft Lesion Location Identification | LEFT FEMORO-POPLITEAL GRAFT |
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| LOCATED | LOCATED | GRAFT ANASTOMOSIS PROXIMAL |
| 5MM FROM THE ORIGIN OF THE GRAFT | PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | BASELINE | 2007-02-01 |
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| 6 | TUDY01 | TU | 40912 | 6 | Limb 1 | Limb with Lesion Location Identification | LOWER LIMB REGION |
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| LOCATED | LOCATED | LEG | LEFT |
| PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | BASELINE | 2007-02-01 |
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| 7 | TUDY01 | TU | 40912 | 7 | Vessel 1-Lesion 1 | Native Vessel with Lesion Role Identification | FEMORO-POPLITEAL PERIPHERAL ARTERY | LEFT |
| NON-TARGET | NON-TARGET |
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| PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | BASELINE | 2007-02-01 |
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| 8 | TUDY01 | TU | 40912 | 8 | Lesion 1 | Lesion Role Identification | POPLITEAL ARTERY | LEFT | ABOVE KNEE | NON-TARGET | NON-TARGET |
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| PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | BASELINE | 2007-02-01 |
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| 9 | TUDY01 | TU | 40912 | 9 | Graft Vessel 1-Lesion 2 | Graft Vessel with Lesion Role Identification | LEFT FEMORO-POPLITEAL GRAFT | LEFT |
| TARGET | TARGET |
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| PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | BASELINE | 2007-02-01 |
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| 10 | TUDY01 | TU | 40912 | 10 | Lesion 2 | Graft Lesion Role Identification | LEFT FEMORO-POPLITEAL GRAFT |
| GRAFT ANASTOMOSIS PROXIMAL | TARGET | TARGET |
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| PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | BASELINE | 2007-02-01 |
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| 11 | TUDY01 | TU | 40912 | 11 | Limb 1 | Limb with Lesion Role Identification | LEG | LEFT |
| TARGET | TARGET |
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| PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | BASELINE | 2007-02-01 |
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