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| Row 1: | Shows the graft vessel was built on the Left Femoral-popliteal Artery. |
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| Row 2: | Shows the bypass graft type was venous cadaveric graft, which is composed of a vein harvested from a cadaver. |
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| Rows 3-4: | Show the graft anastomoses (connections) to the Left Femoral-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 Vessel Construction Location | Peripheral Artery Bypass Graft | Prior Intervention | Left Femoral-popliteal Artery | 1 | SCREEN | 2007-01-01 |
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| 2 | TUDY01 | FA | 40912 | 2 | Bypass Graft Type | Peripheral Artery Bypass Graft | Prior Intervention | Cardaveric Graft, Venous | 1 | SCREEN | 2007-01-01 |
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| 3 | TUDY01 | FA | 40912 | 3 | Graft Anastomosis (connection) Location | Peripheral Artery Bypass Graft | Prior Intervention | Left Common femoral Artery | 1 | SCREEN | 2007-01-01 |
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| 4 | TUDY01 | FA | 40912 | 4 | Graft Anastomosis (connection) Location | Peripheral Artery Bypass Graft | Prior Intervention | Left Popliteal Artery | 1 | SCREEN | 2007-01-01 |
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On 2007-01-05, at an unscheduled visit01, the subject had undergone cardiac catheterization 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 (lesion 2) was located in the left femoral-popliteal graft. While Lesion 1 is considered as non-target, lesion 2 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 2). Note PRDTC (the date of collection) was populated with the start date/time of the procedurethis information is collected on 2007-02-07 during VISIT 1.
Below procedure data show cardiac catheterization and stent implantation.
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | PRSEQ | PRTRT | PRCAT | VISITNUM | VISIT | PRDTC | PRSTDTC | PRENDTC |
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1| 1 | TUDY01 | PR | 40912 | 1 | CT PERIPHERAL ANGIOGRAPHY | PREOPERATIVE DIAGNOSTIC | 2 | VISIT 1 | 2007-02-07 | 2007-01-01T08:00 | 2007-01-01T09:00 |
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| 2 | TUDY01 | PR | 40912 | 2 | Cardiac Catheterization | PVI | 2 |
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1.UNSCHEDULED0105| 07 | 2007-01-05T07:00 | 2007-01- |
05T10211.UNSCHEDULED0105| 07 | 2007-01-05T07:00 | 2007-01- |
05T10
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The below data show Locations and Roles of the identified lesions.
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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. |
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| Row 3: | Shows the major vessel that contains a lesion is the left femoro-popliteal peripheral artery. |
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| Row 4: | Shows the lesion is found in the left popliteal artery, in the segment above the knee. |
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| Row 5: | Shows the major vessel that contains a lesion is the femoro-popliteal graft. |
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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). |
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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 |
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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 1.1 | UNSCHEDULED | 2007-0102-0507 |
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| 2 | TUDY01 | TU | 40912 | 2 | Limb 1 | Limb with Lesion Location Identification | LOWER LIMB REGION |
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| LOCATED | LOCATED | LEG | LEFT |
| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | 1.VISIT 1 | UNSCHEDULED | 2007-0102-0507 |
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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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| LOCATED | LOCATED | FEMORO-POPLITEAL PERIPHERAL ARTERY | LEFT |
| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 1.1 | 2 | VISIT 1UNSCHEDULED | 2007-0102-0507 |
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| 4 | TUDY01 | TU | 40912 | 4 | Lesion 1 | Lesion Location Identification | LOWER LIMB REGION |
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| LOCATED | LOCATED | POPLITEAL ARTERY | LEFT | ABOVE KNEE | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1.1 | UNSCHEDULED | 2007-0102-0507 |
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| 5 | TUDY01 | TU | 40912 | 5 | Graft Vessel 1-Lesion 2 | Vessel with Lesion Location Identification | LOWER LIMB REGION |
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| LOCATED | LOCATED | LEFT FEMORO-POPLITEAL GRAFT |
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| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 1.1 | 2 | VISIT 1UNSCHEDULED | 2007-0102-0507 |
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| 6 | TUDY01 | TU | 40912 | 6 | Lesion 2 | Lesion Location Identification | LOWER LIMB REGION |
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| LOCATED | LOCATED | LEFT FEMORO-POPLITEAL GRAFT |
| ANASTOMOSIS PROXIMAL, 5MM FROM THE ORIGIN OF THE GRAFT | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | 1.VISIT 1UNSCHEDULED | 2007-0102-0507 |
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| 6 | TUDY01 | TU | 40912 | 6 | 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 | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1.1UNSCHEDULED | 2007-0102-0507 |
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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 1.1UNSCHEDULED | 2007-0102-0507 |
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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 | 1.1 | 2 | VISIT 1UNSCHEDULED | 2007-0102-0507 |
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| 9 |
| TU | 40912 | 9 | Graft Vessel 1-Lesion 2 | Vessel with Lesion Role Identification | LEFT FEMORO-POPLITEAL GRAFT | LEFT |
| TARGET | TARGET |
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| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1.1UNSCHEDULED | 2007-0102-0507 |
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| 10 | TUDY01 | TU | 40912 | 10 | Lesion 2 | Lesion Role Identification | LEFT FEMORO-POPLITEAL GRAFT |
| GRAFT ANASTOMOSIS PROXIMAL | TARGET | TARGET |
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| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | 1.VISIT 1UNSCHEDULED | 2007-0102-0507 |
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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 | 1.1 | 2 | VISIT 1UNSCHEDULED | 2007-0102-0507 |
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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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| 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 | TRMETHOD | VISITNUM | VISIT | TRDTC |
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| 1 | TUDY01 | TR | 40912 | 1 | TARGET | Lesion 2 | Lesion Failure Indicator | N | N | PERIPHERAL ANGIOGRAPHY2 | 1.VISIT 1UNSCHEDULED | 2007-0102-0507 |
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| 3 | TUDY01 | TR | 40912 | 3 | TARGET | Graft Vessel 1-Lesion 2 | Vessel Failure Indicator | N | N | PERIPHERAL ANGIOGRAPHY2 | VISIT 1.1 | UNSCHEDULED | 2007-0102-0507 |
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| 4 | TUDY01 | TR | 40912 | 4 | TARGET | Graft Vessel 1-Lesion 2 | Vessel Patency Indicator | Y | Y | PERIPHERAL ANGIOGRAPHY2 | 1.VISIT 1UNSCHEDULED | 2007-0102-0507 |
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| 5 | TUDY01 | TR | 40912 | 5 | TARGET | Limb 1 | Limb Failure Indicator | N | N | PERIPHERAL ANGIOGRAPHY2 | VISIT 1.1 | UNSCHEDULED | 2007-0102-0507 |
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Modeling the above TR data in RS, this is similar to that of Tumor response to treatment modeling in RS.
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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 | Lesion 2 | Lesion Failure Indicator | ACC/AHA Clinical Data Standards 2014 | N | N | 2 |
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1.UNSCHEDULED0105| 07 | | 2 | TUDY01 | RS | 40912 | 1 | TARGET | Graft Vessel 1-Lesion 2 | Vessel Failure Indicator | ACC/AHA Clinical Data Standards 2014 | N | N | 2 | VISIT 1 |
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.1UNSCHEDULED | 0105| 07 | | 3 | TUDY01 | RS | 40912 | 1 | TARGET | Graft Vessel 1-Lesion 2 | Vessel Patency Indicator | ACC/AHA Clinical Data Standards 2014 | Y | Y | 2 |
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1.UNSCHEDULED0105| 07 | | 4 | TUDY01 | RS | 40912 | 1 | TARGET | Limb 1-Lesion 2 | Limb Failure Indicator | ACC/AHA Clinical Data Standards 2014 | N | N |
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1.UNSCHEDULED | 0105
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