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 native LEFT FEMORO-POPLITEAL ARTERYleft femoral-popliteal artery. The lesion was deemed too severe for percutaneous 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 DISEASE SURGERY to show that this is not the study procedure. If CORONARY ARTERY BYPASS GRAFT is the study procedure that treats a target lesion, just change the value in, or remove the PRCATwith 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 |
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Prior Peripheral Artery Bypass Surgery| 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 organically represented as SuppTU (in IG3.4 and the CV TAUG), but I think they are better fitted in FAPR? Thoughts?
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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 an artery a vein harvested from a cadaver. |
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| Rows 3-4: | Show the graft anastomoses (connections) to the native Left Popliteal Left Femoral-popliteal Artery were on the LEFT COMMON FEMORAL ARTERY and LEFT POPLITEAL ARTERYLeft Common femoral Artery and Left Popliteal Artery. |
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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 | graft01 | 2Graft Vessel Construction Location | Bypass Graft Type | Prior Peripheral Artery Bypass Surgery | Left Femoral-popliteal Artery | 1 | SCREEN | 2007-01-01 | 2 | TUDY01 | FA | 40912 | 2 | Bypass Graft Type | Bypass Graft | Prior Peripheral Artery Bypass SurgeryIntervention | Cadaveric Cardaveric 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 Peripheral Artery Bypass SurgeryIntervention | 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 Peripheral Artery Bypass SurgeryIntervention | Left Popliteal Artery | 1 | SCREEN | 2007-01-01 |
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On 2007-01-05, at an unscheduled visit03, 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 (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 . A treatment. On 2007-01-05, a stent was implant implanted into the left femoral-popliteal graft to correct the stenosis caused by the lesion (Lesion 2). PRDTC (the date of collection) was populated with the start date/time of the proceduregraft lesion 1). Note this 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 | PRLOC | VISITNUM | VISIT | PRDTC | PRSTDTC | PRENDTC |
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1Cardiac Catheterization | Diagnostic | 1.1 | UNSCHEDULED | 2007-01-05 | CT PERIPHERAL ANGIOGRAPHY | DIAGNOSTIC | LOWER EXTREMITIES | 2 | VISIT 1 | 2007-02-07 | 2007-01-03T08:00 | 2007-01-03T09:00 |
| TUDY01 | PR | 40912 | 2 | CT PERIPHERAL ANGIOGRAPHY | PVI |
| 2 | VISIT 1 | 2007-02-07 | 2007-01-05T07:00 | 2007-01- |
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05T10| 05T09:00 | | 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 |
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1.UNSCHEDULED0105| 07 | 2007-01-05T07:00 | 2007-01- |
05T10
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Lesion Type and Location Identification
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| title | Peripheral Artery Lesion CRF |
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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 Location and Role 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. |
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| Row 3: | shows the native vessel that contains a lesion is the left femoro-popliteal peripheral artery. |
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| Row 4: | Shows the lesion is found 1 is identified in the left popliteal artery above the knee. |
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| Row 53: | Shows the vessel that contains a lesion is the femoro-popliteal graft . | Row 6: | Shows the lesion lesion 1 is located in the proximal anastomosis (connection) of the femoro-popliteal artery graft. |
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| Row 7: | Shows the affected 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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| Note 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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| 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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| Rowcaps |
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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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| hi1style | #e3fcef |
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| hi1 | TRLOC |
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tableidRow | STUDYID | DOMAIN | USUBJID | TUSEQ | TUREFID | TULNKID | TUTESTCD | TUTEST | TULOC |
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TULAT | TULOCDTLTU Result LOC | TU Result LAT | TU Result LOCDTL| TURESLOC | TURESLAT | RLODTL | TUMETHOD | TUEVEL | VISITNUM | VISIT | TUDTC |
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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 |
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1.UNSCHEDULED0105Limb 1 | Limb with Lesion Location Identification | LOWER LIMB REGION | LOCATED | LOCATED | LEG | LEFT | PERIPHERAL ANGIOGRAPHYINVESTIGATOR | 1.1 | UNSCHEDULED | 2007-01-05 | 3 | TUDY01 | TU | 40912 | 3 | Vessel 1-4 | TUDY01 | TU | 40912 | 4 | Lesion 1 | Lesion Location Identification | Vessel with Lesion Location Identification | LOWER LIMB REGION | LOCATED | LOCATED | FEMORO-POPLITEAL PERIPHERAL ARTERY | LEFT | PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 1.1 | UNSCHEDULED | 2007-01-05 | | ABNEXAM | Examination for Abnormality |
LOCATEDLOCATED| LESION | POPLITEAL ARTERY | LEFT | ABOVE KNEE | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 |
1.UNSCHEDULED010555 Vessel 1-Lesion 2| Lesion 1 | ABNEXAM | Examination for Abnormality |
Vessel with Lesion Location IdentificationLOCATEDLOCATEDLEFT GRAFTPERIPHERAL 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 | | ARTERY | LEFT | PROXIMAL ANASTOMOSIS, 5MM FROM THE ORIGIN OF THE GRAFT | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR |
1.1 | UNSCHEDULED | 2007-01-05 | 6TUDY01 | TU | 40912 | 6 | Lesion Graft Lesion Location Identification | LEFT FEMORO-POPLITEAL GRAFT | LOCATED | LOCATED | GRAFT ANASTOMOSIS PROXIMAL | 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 | |
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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 lesion or the affected vessel have failed (or using tumor RS terminology, did not responded to) percutaneous vascular intervention treatment has very specific definition by published criteria.
Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRGRPID | TRLNKID | TRTEST | TRORRES | TRSTRESC | TRMETHOD | VISITNUM | | TR1 | CVDTC | TUDY01TR | 40912 | 1 | TARGET | Lesion 2 | Lesion Failure Indicator | N | N | PERIPHERAL ANGIOGRAPHY | 2 | BASELINE | 01| 3 | TUDY01 | TR | 40912 | 3 | TARGET | Graft Vessel 1-Lesion 2 | Vessel Failure Indicator | N | N | PERIPHERAL ANGIOGRAPHY | 2 | BASELINE | 2007-02-01 |
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| 4 | TUDY01 | TR | 40912 | 4 | TARGET | Graft Vessel 1-Lesion 2 | Vessel Patency Indicator | Y | Y | PERIPHERAL ANGIOGRAPHY | 2 | BASELINE | 2007-02-01 |
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| 5 | TUDY01 | TR | 40912 | 5 | TARGET | Limb 1-Lesion 2 | Limb Failure Indicator | N | N | PERIPHERAL ANGIOGRAPHY | 2 | BASELINE | 2007-02-01 |
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I think this should be modeled in RS in the following fashion, similar to that of Tumor response to treatment modeling in RS.
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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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Row
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STUDYID
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DOMAIN
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USUBJID
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RSLNKID
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RSTEST
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RSSTRESC
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VISITNUM
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VISIT
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CVDTC
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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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