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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.
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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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The below data show Locations of the lesions.
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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 lesion location identification from the diagnostic CT peripheral angiography procedure
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Row
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STUDYID
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DOMAIN
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USUBJID
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TUTEST
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TULOC
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TUORRES
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TUMETHOD
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VISITNUM
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VISIT
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TUDTC
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TUDY01
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TUDY01
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TUDY01
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Question: Can we use LOC for Graft locations? LOC in most findings domains is supposed to be the location where a test is performed, and RESLOC is where a result is collected. SDTM does not specify that the location needs to be a "naturally occurring" body part. A reminder that the value in TULOC in this example, is a location made available for viewing via imaging, and you are observing based off of a image, so we are not doing assessments on a naturally occurring, in vitro body part either.
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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 location of the lesion in the native vessel. |
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| Row 3: | Shows the location of the lesion is in the FEMORO-POPLITEAL graft. |
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| | Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TULNKID | TUTEST | TULOC | 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 | Y | Y | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 | | 2 | TUDY01 | TU | 40912 | 2 | Lesion 1 | Lesion Location Identification | LOWER LIMB REGION | IDENTIFIED | IDENTIFIED | POPLITEAL ARTERY | LEFT | ABOVE KNEE | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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| 3 | TUDY01 | TU | 40912 | 3 | Graft Lesion 1 | Lesion Location Identification | LOWER LIMB REGION | IDENTIFIED | IDENTIFIED | LEFT FEMORO-POPLITEAL GRAFT | LEFT | PROXIMAL ANASTOMOSIS, 5MM FROM THE ORIGIN OF THE GRAFT | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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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 lesion 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. |
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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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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 | LOGFIND | 1 | 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 | 2 | TUDY01 | TU | 40912 | 10 | Graft Lesion 1 | Lesion Role Identification | See NSV | TARGET | TARGET | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 | LEFT FEMORO-POPLITEAL GRAFT |
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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 location of the lesion in the native vessel. |
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| Row 3: | Shows the location of the lesion is in the FEMORO-POPLITEAL ARTERY graft. lesion 1 is located in the femoro-popliteal artery graft. Note the use of the NSV --RLGFFG, location is graft flagResult Location is Graft Flag. Note i 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 | TUORRES | TUSTRESC | TU Result LOC | TU Result LAT | TURESLOC | TURESLAT | RLODTLTU Result LOCDTL | TUMETHOD | TUEVEL | VISITNUM | VISIT | TUDTC |
| TURLGFFGTURLGFFL |
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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 |
| Lesion 1Lesion Location Identification | ABNEXAM | Examination for Abnormality | LOWER LIMB REGION | IDENTIFIEDLESIONIDENTIFIED | LESION | POPLITEAL ARTERY | LEFT | ABOVE KNEE | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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| 3 | TUDY01 | TU | 40912 | 3 | graft01 | Graft Lesion 1Lesion Location Identification | ABNEXAM | Examination for Abnormality | LOWER LIMB REGION | IDENTIFIEDLESIONIDENTIFIED | LESION | FEMORO-POPLITEAL ARTERY | LEFT | PROXIMAL ANASTOMOSIS, 5MM FROM THE ORIGIN OF THE GRAFT | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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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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