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Prior and Current Procedures
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 percutaneous vascular intervention (PVI), hence a bypass graft surgery was performed. Note PRCAT is populated with Prior Intervention. This information is collected during the SCREEN visit on 2007-01-01 (PRDTC).
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | PRREFID | PRSEQ | PRTRT | PRLOC | PRLAT | PRCAT | VISITNUM | VISIT | PRDTC | PRSTDTC | PRENDTC |
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| 1 | TUDY01 | PR | 40912 | graft01 | 1 | Peripheral Artery Bypass Graft | Femoral-popliteal Artery | Left | Prior Intervention | 1 | SCREEN | 2007-01-01 | 2005-12-16T06:00 | 2005-12-16T09:00 |
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The findings about procedure dataset below shows several important parameters from the Prior Peripheral Artery Bypass Surgery:
- The native vessel on which the bypass graft was built - row 1.
- The type of the bypass graft (e.g. arterial, venous, synthetic, cadaveric) - row 2
- The locations where the two ends of the bypass vessel graft connect with the native vessel - rows 3-4.
These records were originally represented as SUPPTU (in IG3.4 and the CV TAUG), but I think they are better fitted for FAPR? Thoughts?
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| Rowcaps |
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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 | FAREFID | FASEQ | FATEST | FAOBJ | FACAT | FAORRES | VISITNUM | VISIT | TUDTC |
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| 12 | TUDY01 | FA | 40912 | 1 | Graft Vessel Construction Location | Peripheral Artery Bypass Graft | Prior Intervention | Left Femoral-popliteal Artery | 1 | SCREEN | 2007-01-01 | graft01 | 2 | 2 | TUDY01 | FA | 40912 | 2 | Bypass Graft Type | Peripheral Artery Bypass Graft | Prior Intervention | Cardaveric Cadaveric Graft, Venous | 1 | SCREEN | 2007-01-01 |
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| 3 | TUDY01 | FA | 40912 | graft01 | 3 | Proximal 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 | graft01 | 4 | Distal Graft Anastomosis (connection) Location | Peripheral Artery Bypass Graft | Prior Intervention | Left Popliteal Artery | 1 | SCREEN | 2007-01-01 |
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On 2007-01-03, 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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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | PRSEQ | PRTRT | PRCAT | PRLOC | VISITNUM | VISIT | PRDTC | PRSTDTC | PRENDTC |
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| 1 | TUDY01 | PR | 40912 | 1 | CT PERIPHERAL ANGIOGRAPHY | DIAGNOSTIC | LOWER EXTREMITIES | 2 | VISIT 1 | 2007-02-07 | 2007-01-03T08:00 | 2007-01-03T09:00 |
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| TUDY01 | PR | 40912 | 2 | CT PERIPHERAL ANGIOGRAPHY | PVI |
| 2 | VISIT 1 | 2007-02-07 | 2007-01-05T07:00 | 2007-01-05T09:00 |
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| 2 | TUDY01 | PR | 40912 | 23 | Cardiac Catheterization | PVI |
| 2 | VISIT 1 | 2007-02-07 | 2007-01-05T07:00 | 2007-01-05T09:00 |
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| 3 | TUDY01 | PR | 40912 | 34 | Stent Implantation | PVI |
| 2 | VISIT 1 | 2007-02-07 | 2007-01-05T07:00 | 2007-01-05T09:00 |
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Lesion Type and Location Identification
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| title | Peripheral Artery Lesion CRF |
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| Include Page |
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| CDASH for Peripheral Arterial Lesion |
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| CDASH for Peripheral Arterial Lesion |
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The below data show Locations and Roles of the identified lesionslesion location identification from the diagnostic CT peripheral angiography procedure.
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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 1 is identified 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 53: | Shows the major vessel that contains a lesion is the femoro-popliteal graft . Note TULNKID is created for this record. | Row 6: | Shows the lesion lesion 1 is located in the proximal anastomosis (connection) of the femoro-popliteal artery 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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| the use of the NSV --RLGFFG, Result Location is Graft Flag. Note I did map PROXIMAL ANASTOMOSIS, 5MM FROM THE ORIGIN OF THE GRAFT to TU result LOCDTL because this variable is not controlled and the flag indicates that we are dealing with a graft location. |
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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 | TUREFID | TULNKID | TUTESTCD | TUTEST | TULOC |
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TULATTULOCDTL | TU Result LOC | TU Result LAT | TU Result LOCDTL| TURESLOC | TURESLAT | RLODTL | TUMETHOD | TUEVEL | VISITNUM | VISIT | TUDTC |
| TURLGFFL |
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| 1 | TUDY01 | TU | 40912 | 1 |
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| LESIONIND | Lesion Indicator | LOWER LIMB REGION | 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 |
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Limb 1 | Limb with LOWER LIMB REGION | LOCATED | LOCATED | LEG | LEFT | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 | 3 | TUDY01 | TU | 40912 | 3 | Vessel 1-Lesion 1 | Vessel with Lesion Location Identification | Location Identification| 1 | ABNEXAM | Examination for Abnormality |
LOCATEDLOCATEDFEMORO- PERIPHERAL CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR2 | VISIT 1 | 2007-02-07 | 4 | TUDY01 | TU | 40912 | 4 | Lesion 1 | Lesion Location Identification | LOWER LIMB REGION | LOCATED | LOCATED | POPLITEAL ARTERY | LEFT | | ABOVE KNEE | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
55 Vessel 1-Vessel with Lesion Location Identification | LOWER LIMB REGION | LOCATED | LOCATED | LEFT FEMORO-POPLITEAL GRAFT | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 | 6 | TUDY01 | TU | 40912 | 6 | Lesion 2 | Lesion Location Identification | 2| 1 | ABNEXAM | Examination for Abnormality |
LOCATEDLOCATEDLEFT GRAFTANASTOMOSIS PROXIMAL, 5MM FROM THE ORIGIN OF THE GRAFT | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 | | ARTERY | LEFT | PROXIMAL ANASTOMOSIS, |
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 | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
7TUDY01 | TU | 40912 | 7 | Vessel 1-Lesion 1 | Vessel with Lesion Role Identification | FEMORO-POPLITEAL PERIPHERAL ARTERY | LEFT | NON-TARGET | NON-TARGET | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 | 8 | TUDY01 | TU | 40912 | 8 | Lesion 1 | Lesion Role Identification | POPLITEAL ARTERY | LEFT | ABOVE KNEE | NON-TARGET | NON-TARGET | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 | 9 | TU | 40912 | 9 | Graft Vessel 1-Lesion 2 | Vessel with Lesion Role Identification | LEFT FEMORO-POPLITEAL GRAFT | TARGET | TARGET | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 | 10 | TUDY01 | TU | 40912 | 10 | Lesion 2 | Lesion Role Identification | LEFT FEMORO-POPLITEAL GRAFT | GRAFT ANASTOMOSIS PROXIMAL | TARGET | TARGET | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 | 11 | TUDY01 | TU | 40912 | 11 | Limb 1 | Limb with Lesion Role Identification | LEG | LEFT | TARGET | TARGET | 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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| Nsvmeta |
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| Variable | Label | Type | Role | Origin |
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| TURLGFFL | Result location is Graft Flag | text | Non-Standard Record Qualifier | CRF |
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| hi1style | #e3fcef |
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| hi1 | TRLOC |
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| tableid | TR1 |
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Row
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STUDYID
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DOMAIN
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USUBJID
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TRLNKID
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TRTEST
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TRORRES
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VISITNUM
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VISIT
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TRDTC
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TUDY01
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TUDY01
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TUDY01
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Vessel Patency Indicator
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TUDY01
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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 | VISIT 1 | 2007-02-07 |
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| 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 | 2007-02-07 |
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| 3 | TUDY01 | RS | 40912 | 1 | TARGET | Graft Vessel 1-Lesion 2 | 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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