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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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| 2 | TUDY01 | FA | 40912 | graft01 | 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 | 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 | Popliteal Artery | 1 | SCREEN | 2007-01-01 |
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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 | 3 | 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 | 4 | 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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| 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. | 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. | 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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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TUREFID | TULNKID | TUTESTCD | TUTEST | TULOC | TULAT | TULOCDTL | TUORRES | TUSTRESC | TU Result LOC | TU Result LAT | TURESLOC | TURESLAT | RLODTLTU Result LOCDTL | TUMETHOD | TUEVEL | VISITNUM | VISIT | TUDTC | Test Graft Location | Test Graft Location Detail | Result Graft Location |
| Result Graft Location DetailTURLGFFL |
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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 | 2Limb 1 |
| Limb with Lesion Location Identification | LOWER LIMB REGION | IDENTIFIED | IDENTIFIED | LEG | LEFT | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 | 3 | TUDY01 | TU | 40912 | 3 | Vessel 1-Lesion 1 | 1 | ABNEXAM | Examination for AbnormalityVessel with Lesion Location Identification | LOWER LIMB REGION | IDENTIFIED | IDENTIFIED | FEMORO-POPLITEAL PERIPHERAL ARTERY | LEFT | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 | 4 | TUDY01 | TU | 40912 | 4 | Lesion 1 | Lesion Location Identification | LOWER LIMB REGION | IDENTIFIED | LESION | LESIONIDENTIFIED | POPLITEAL ARTERY | LEFT | ABOVE KNEE | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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| 53 | TUDY01 | TU | 40912 | 3 | graft015 | Graft Vessel 1-Graft Lesion 1Vessel with Lesion Location Identification | ABNEXAM | Examination for Abnormality | LOWER LIMB REGION | IDENTIFIEDLESION | IDENTIFIED | See NSV | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 | LEFT FEMORO-POPLITEAL GRAFT | 6 | TUDY01 | TU | 40912 | 6 | Graft Lesion 1 | Lesion Location Identification | LOWER LIMB REGION | IDENTIFIED | IDENTIFIED | See NSV | See NSV | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 | LEFT FEMORO-POPLITEAL GRAFT | LESION | FEMORO-POPLITEAL ARTERY | LEFT | PROXIMAL ANASTOMOSIS, ANASTOMOSIS PROXIMAL, 5MM FROM THE ORIGIN OF THE GRAFT | 7 | TUDY01 | 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
| Y | 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-Graft Lesion 1 | Vessel with Lesion Role Identification | See NSV | TARGET | TARGET | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 | LEFT FEMORO-POPLITEAL GRAFT | 10 | TUDY01 | TU | 40912 | 10 | Graft Lesion 1 | Lesion Role Identification | See NSV | See NSV | TARGET | TARGET | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 | LEFT FEMORO-POPLITEAL GRAFT | GRAFT ANASTOMOSIS PROXIMAL | 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 | Graft Lesion 1 | 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 1 | 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 1 | 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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