Subject 40912 had a previous peripheral artery bypass surgery that took place on 2005-12-16 because a lesion was identified in the left femoral-popliteal artery. The lesion was deemed severe and extensive and the subject was not a good candidate for angioplasty (PVI), hence a bypass graft surgery was performed. Note PRCAT is populated with PRIOR DISEASE SURGERY with Prior Intervention to show that this is not the study procedure.
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
Row | STUDYID | DOMAIN | USUBJID | PRSEQ | PRTRT | PRCAT | VISITNUM | VISIT | PRDTC | PRSTDTC | PRENDTC |
|---|
| 1 | TUDY01 | PR | 40912 | 1 | Peripheral Artery Bypass Graft | Prior |
|---|
Peripheral Artery Bypass Surgery| Intervention | 1 | SCREEN | 2007-01-01 | 2005-12-16T06:00 | 2005-12-16T09:00 |
|
|
The findings about procedure dataset below shows several important parameters from the Prior Peripheral Artery Bypass Surgery:
...
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
| Row 1: | Shows the graft vessel was built on the Left Femoral-popliteal Artery. |
|---|
| Row 2: | Shows the bypass graft type was venous cadaveric graft, which is composed of a vein harvested from a cadaver. |
|---|
| 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. |
|---|
|
| Dataset2 |
|---|
|
Row | STUDYID | DOMAIN | USUBJID | FASEQ | FATEST | FAOBJ | FACAT | FAORRES | VISITNUM | VISIT | TUDTC |
|---|
| 1 | TUDY01 | FA | 40912 | 1 | Graft Vessel Construction Location | Peripheral Artery Bypass Graft | Prior Peripheral Artery Bypass SurgeryIntervention | Left Femoral-popliteal Artery | 1 | SCREEN | 2007-01-01 |
|---|
| 2 | TUDY01 | FA | 40912 | 2 | Bypass Graft Type | Peripheral Artery Bypass Graft | Prior Peripheral Artery Bypass SurgeryIntervention | Cardaveric Graft, Venous | 1 | SCREEN | 2007-01-01 |
|---|
| 3 | TUDY01 | FA | 40912 | 3 | Graft Anastomosis (connection) Location | Peripheral Artery Bypass Graft | Prior Peripheral Artery Bypass SurgeryIntervention | Left Common femoral Artery | 1 | SCREEN | 2007-01-01 |
|---|
| 4 | TUDY01 | FA | 40912 | 4 | Graft Anastomosis (connection) Location | Peripheral Artery Bypass Graft | Prior Peripheral Artery Bypass SurgeryIntervention | Left Popliteal Artery | 1 | SCREEN | 2007-01-01 |
|---|
|
|
...
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
| Row 1: | Shows one or more lesions have been identified in the lower limb region. |
|---|
| Row 2: | Shows the limb that contains lesion is the left leg. |
|---|
| Row 3: | Shows the major vessel that contains a lesion is the left femoro-popliteal peripheral artery. |
|---|
| Row 4: | Shows the lesion is found in the left popliteal artery, in the segment above the knee. |
|---|
| Row 5: | Shows the major vessel that contains a lesion is the femoro-popliteal graft. |
|---|
| 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). |
|---|
| 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) |
|---|
| 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) |
|---|
| 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) |
|---|
| 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) |
|---|
| Row 11: | Shows the left leg is considered as target. |
|---|
|
| Dataset2 |
|---|
| hi1style | yellow |
|---|
| hi2 | 7 |
|---|
| hi1 | 6 |
|---|
| hi2style | aqua |
|---|
| tableid | TU1 |
|---|
|
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 |
|---|
| 1 | TUDY01 | TU | 40912 | 1 |
| Lesion Indicator | LOWER LIMB REGION |
|
| Y | Y |
|
|
| PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 1.1 | UNSCHEDULED | 2007-01-05 |
|---|
| 2 | TUDY01 | TU | 40912 | 2 | Limb 1 | Limb with Lesion Location Identification | LOWER LIMB REGION |
|
| LOCATED | LOCATED | LEG | LEFT |
| PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 1.1 | UNSCHEDULED | 2007-01-05 |
|---|
| 3 | TUDY01 | TU | 40912 | 3 | Vessel 1-Lesion 1 | Vessel with Lesion Location Identification | LOWER LIMB REGION |
|
| LOCATED | LOCATED | FEMORO-POPLITEAL PERIPHERAL ARTERY | LEFT |
| PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 1.1 | UNSCHEDULED | 2007-01-05 |
|---|
| 4 | TUDY01 | TU | 40912 | 4 | Lesion 1 | Lesion Location Identification | LOWER LIMB REGION |
|
| LOCATED | LOCATED | POPLITEAL ARTERY | LEFT | ABOVE KNEE | PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 1.1 | UNSCHEDULED | 2007-01-05 |
|---|
| 5 | TUDY01 | TU | 40912 | 5 | Graft Vessel 1-Lesion 2 | Vessel with Lesion Location Identification | LOWER LIMB REGION |
|
| LOCATED | LOCATED | LEFT FEMORO-POPLITEAL GRAFT |
|
| PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 1.1 | UNSCHEDULED | 2007-01-05 |
|---|
| 6 | TUDY01 | TU | 40912 | 6 | Lesion 2 | Lesion Location Identification | LOWER LIMB REGION |
|
| LOCATED | LOCATED | LEFT FEMORO-POPLITEAL GRAFT |
| GRAFT ANASTOMOSIS PROXIMAL, 5MM FROM THE ORIGIN OF THE GRAFT | PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 1.1 | UNSCHEDULED | 2007-01-05 |
|---|
| 6 | TUDY01 | TU | 40912 | 6 | Lesion 2 | Graft Lesion Location Identification | LEFT FEMORO-POPLITEAL GRAFT |
|
| LOCATED | LOCATED | GRAFT ANASTOMOSIS PROXIMAL |
| 5MM FROM THE ORIGIN OF THE GRAFT | PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 1.1 | UNSCHEDULED | 2007-01-05 |
|---|
| 7 | TUDY01 | TU | 40912 | 8 | Vessel 1-Lesion 1 | Vessel with Lesion Role Identification | FEMORO-POPLITEAL PERIPHERAL ARTERY | LEFT |
| NON-TARGET | NON-TARGET |
|
|
| PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 1.1 | UNSCHEDULED | 2007-01-05 |
|---|
| 8 | TUDY01 | TU | 40912 | 9 | Lesion 1 | Lesion Role Identification | POPLITEAL ARTERY | LEFT | ABOVE KNEE | NON-TARGET | NON-TARGET |
|
|
| PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 1.1 | UNSCHEDULED | 2007-01-05 |
|---|
| 9 |
| TU | 40912 | 10 | Graft Vessel 1-Lesion 2 | Vessel with Lesion Role Identification | LEFT FEMORO-POPLITEAL GRAFT | LEFT |
| TARGET | TARGET |
|
|
| PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 1.1 | UNSCHEDULED | 2007-01-05 |
|---|
| 10 | TUDY01 | TU | 40912 | 11 | Lesion 2 | Lesion Role Identification | LEFT FEMORO-POPLITEAL GRAFT |
| GRAFT ANASTOMOSIS PROXIMAL | TARGET | TARGET |
|
|
| PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 1.1 | UNSCHEDULED | 2007-01-05 |
|---|
| 11 | TUDY01 | TU | 40912 | 12 | Limb 1 | Limb with Lesion Role Identification | LEG | LEFT |
| TARGET | TARGET |
|
|
| PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 1.1 | UNSCHEDULED | 2007-01-05 |
|---|
|
|
...