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On 2007-01-03, the subject had undergone lower-extremity CT peripheral angiography during which time two separate lesions were located in the left leg of the subject. One lesion (lesion 1) was in the native left femoral-popliteal artery (this was the lesion that led to the graft bypass surgery back in 2005) the other lesion (graft lesion 21) was located in the left femoral-popliteal graft. While Lesion 1 is considered as non-target, graft lesion 2 1 is considered as target for the subsequent PVI treatment. On 2007-01-05, a stent was implanted into the left femoral-popliteal graft to correct the stenosis caused by the lesion (Lesion 2graft lesion 1). Note this information is collected on 2007-02-07 during VISIT 1.
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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 limb that contains lesion is the left leg. Note TULNKID is created for this record because this limb will undergo "role" assessment and disease response to treatment assessment. |
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| Row 3: | Shows the major vessel that contains a lesion is the left femoro-popliteal peripheral artery. Note TULNKID is created for this record because this affected vessel will undergo "role" assessment and disease response to treatment assessment. |
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| Row 4: | Shows the lesion is found in the left popliteal artery, in the segment above the knee. Note TULNKID is created for this record because this lesion will undergo "role" assessment and disease response to treatment assessment. |
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| Row 5: | Shows the major vessel that contains a lesion is the femoro-popliteal graft. Note TULNKID is created for this record. |
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| Row 6: | Shows the lesion is located in the proximal anastomosis (connection) of the femoro-popliteal graft. (Note I created two rows here, depending on how you ask the question, whether "graft" is pre-coordinated into TUTEST, TULOC value will change). Note TULNKID is created for this record. |
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| Row 7: | Shows the affected left femoro-popliteal peripheral artery is considered as non-target. In the context of clinical investigation, non-target is 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 affected femoro-popliteal graft vessel is considered as target. In the context of clinical investigation, a target vessel is a blood vessel that contains the target lesion and treated with the study device. (ACC/AHA Clinical Data Standards 2014) |
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| Row 10: | Shows the lesion in the femoro-popliteal graft vessel is considered as 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. |
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| Dataset2 |
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| hi1style | yellow |
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| hi2 | 7 |
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| hi1 | 6 |
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| hi2style | aqua |
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| tableid | TU1 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TULNKID | TUTEST | TULOC | TULAT | TULOCDTL | TUORRES | TUSTRESC | TU Result LOC | TU Result LAT | TU Result LOCDTL | TUMETHOD | TUEVEL | VISITNUM | VISIT | TUDTC |
| Test Graft Location | Test Graft Location Detail | Result Graft Location | Result Graft Location Detail |
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| 1 | TUDY01 | TU | 40912 | 1 |
| Lesion Indicator | LOWER LIMB REGION |
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| Y | Y |
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| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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| 2 | TUDY01 | TU | 40912 | 2 | Limb 1 | Limb with Lesion Location Identification | LOWER LIMB REGION |
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| IDENTIFIED | IDENTIFIED | LEG | LEFT |
| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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| 3 | TUDY01 | TU | 40912 | 3 | Vessel 1-Lesion 1 | Vessel with Lesion Location Identification | LOWER LIMB REGION |
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| IDENTIFIED | IDENTIFIED | FEMORO-POPLITEAL PERIPHERAL ARTERY | LEFT |
| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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| 4 | TUDY01 | TU | 40912 | 4 | Lesion 1 | Lesion Location Identification | LOWER LIMB REGION |
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| IDENTIFIED | IDENTIFIED | POPLITEAL ARTERY | LEFT | ABOVE KNEE | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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| 5 | TUDY01 | TU | 40912 | 5 | Graft Vessel 1-Graft Lesion |
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2| 1 | Vessel with Lesion Location Identification | LOWER LIMB REGION |
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| IDENTIFIED | IDENTIFIED |
LEFT FEMORO-POPLITEAL GRAFT| See NSV |
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| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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| LEFT FEMORO-POPLITEAL GRAFT |
| | 6 | TUDY01 | TU | 40912 | 6 | Graft Lesion |
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2| 1 | Lesion Location Identification | LOWER LIMB REGION |
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| IDENTIFIED | IDENTIFIED |
LEFT FEMORO-POPLITEAL GRAFT | ANASTOMOSIS PROXIMAL, 5MM FROM THE ORIGIN OF THE GRAFT | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
6 | TUDY01 | TU | 40912 | 6 | Lesion 2 | Graft Lesion Location Identification |
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| LEFT FEMORO-POPLITEAL GRAFT |
IDENTIFIED | IDENTIFIEDGRAFT | , 5MM FROM THE ORIGIN OF THE GRAFT |
CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR2 | VISIT 1 | 2007-02-07 |
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| 7 | TUDY01 | TU | 40912 | 7 | Vessel 1-Lesion 1 | Vessel with Lesion Role Identification | FEMORO-POPLITEAL PERIPHERAL ARTERY | LEFT |
| NON-TARGET | NON-TARGET |
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| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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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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| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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| 9 |
| TU | 40912 | 9 | Graft Vessel 1-Graft Lesion |
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2| 1 | Vessel with Lesion Role Identification |
LEFT FEMORO-POPLITEAL GRAFT| See NSV |
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| TARGET | TARGET |
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| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
| LEFT FEMORO-POPLITEAL GRAFT |
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| | 10 | TUDY01 | TU | 40912 | 10 | Graft Lesion |
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2| 1 | Lesion Role Identification |
LEFT FEMORO-POPLITEAL GRAFT | GRAFT ANASTOMOSIS PROXIMAL | TARGET | TARGET |
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| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
| LEFT FEMORO-POPLITEAL GRAFT | GRAFT ANASTOMOSIS PROXIMAL |
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| | 11 | TUDY01 | TU | 40912 | 11 | Limb 1 | Limb with Lesion Role Identification | LEG | LEFT |
| TARGET | TARGET |
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| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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Note the following parameters have been mapped to TR in the published CV-endpoint TAUG, but I wonder if they are actually "disease response to treatment" type of data. Whether the target lesion or the target affected major vessel have failed (or using tumor RS terminology, did not responded to) percutaneous vascular intervention treatment has very specific definition by published criteria.
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| Rowcaps |
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| Row 1: | The target lesion in the graft did not fail according to XXXX. |
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| Row 2: | The target graft vessel did not fail according to XXX. |
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| Row 3: | The target graft vessel is patent according to XXX. |
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| Row 4: | The target limb did not fail according to XXXX. |
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| Dataset2 |
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| hi1style | #e3fcef |
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| hi1 | TRLOC |
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| tableid | TR1 |
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Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRGRPID | TRLNKID | TRTEST | TRORRES | TRSTRESC | VISITNUM | VISIT | TRDTC |
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| 1 | TUDY01 | TR | 40912 | 1 | TARGET | Graft Lesion 21 | Lesion Failure Indicator | N | N | 2 | VISIT 1 | 2007-02-07 |
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| 3 | TUDY01 | TR | 40912 | 3 | TARGET | Graft Vessel 1-Graft Lesion 21 | Vessel Failure Indicator | N | N | 2 | VISIT 1 | 2007-02-07 |
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| 4 | TUDY01 | TR | 40912 | 4 | TARGET | Graft Vessel 1-Graft Lesion 21 | Vessel Patency Indicator | Y | Y | 2 | VISIT 1 | 2007-02-07 |
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| 5 | TUDY01 | TR | 40912 | 5 | TARGET | Limb 1 | Limb Failure Indicator | N | N | 2 | VISIT 1 | 2007-02-07 |
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| Dataset wrap |
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| Rowcaps |
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| Row 1: | The target lesion in the graft did not fail treatment according to ACC/AHA Clinical Data Standards 2014. |
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| Row 2: | The target graft vessel did not fail treatment according to ACC/AHA Clinical Data Standards 2014. |
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| Row 3: | The target graft vessel is patent according to ACC/AHA Clinical Data Standards 2014. |
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| Row 4: | The target limb did not fail treatment according to ACC/AHA Clinical Data Standards 2014. |
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSGRPID | RSLNKID | RSTEST | RSCAT | RSORRES | RSSTRESC | VISITNUM | VISIT | RSDTC |
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| 1 | TUDY01 | RS | 40912 | 1 | TARGET | Graft Lesion 21 | Lesion Failure Indicator | ACC/AHA Clinical Data Standards 2014 | N | N | 2 | VISIT 1 | 2007-02-07 |
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| 2 | TUDY01 | RS | 40912 | 1 | TARGET | Graft Vessel 1-Graft Lesion 21 | Vessel Failure Indicator | ACC/AHA Clinical Data Standards 2014 | N | N | 2 | VISIT 1 | 2007-02-07 |
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| 3 | TUDY01 | RS | 40912 | 1 | TARGET | Graft Vessel 1-Graft Lesion 21 | Vessel Patency Indicator | ACC/AHA Clinical Data Standards 2014 | Y | Y | 2 | VISIT 1 | 2007-02-07 |
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| 4 | TUDY01 | RS | 40912 | 1 | TARGET | Limb 1-Lesion 2 | Limb Failure Indicator | ACC/AHA Clinical Data Standards 2014 | N | N | 2 | VISIT 1 | 2007-02-07 |
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