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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 ARTERY. The lesion was deemed too severe 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 or remove the PRCAT.

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Row

STUDYID

DOMAIN

USUBJID

PRSEQ

PRTRT

PRCATVISITNUM

VISIT

PRDTCPRSTDTCPRENDTC
 1

TUDY01

PR409121

Bypass Graft

Prior Peripheral Artery Bypass Surgery1SCREEN2007-01-01

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:

  1. The native vessel on which the bypass graft was built - row 1.
  2. The type of the bypass graft (e.g. arterial, venous, synthetic, cadaveric) - row 2
  3. 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?

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 an artery harvested from a cadaver.
Rows 3-4:Show the graft anastomoses (connections) to the native Left Popliteal Artery were on the LEFT COMMON FEMORAL ARTERY and LEFT POPLITEAL ARTERY.

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Row

STUDYID

DOMAIN

USUBJID

FASEQ

FATEST

FAOBJFACATFAORRES

VISITNUM

VISIT

TUDTC

1TUDY01FA409121Graft Vessel Construction LocationBypass GraftPrior Peripheral Artery Bypass Surgery

Left Femoral-popliteal Artery

1SCREEN2007-01-01
2TUDY01FA409122

Bypass Graft Type

Bypass GraftPrior Peripheral Artery Bypass Surgery

Cardaveric Graft, Venous

1SCREEN2007-01-01
3TUDY01FA409123Graft Anastomosis (connection) LocationBypass GraftPrior Peripheral Artery Bypass SurgeryLeft Common femoral Artery1SCREEN2007-01-01
4TUDY01FA409124

Graft Anastomosis (connection) Location

Bypass GraftPrior Peripheral Artery Bypass SurgeryLeft Popliteal Artery1SCREEN2007-01-01

Dataset Debug Message

There is a leading, trailing, or non-breaking space in the dataset.

Dataset Wrapper Debug Message

Please add a row column to your dataset.

On 2007-02-01, during the Peripheral Vascular Intervention (PVI) procedure 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 (lesion 2) was located in the left femoral-popliteal graft. While Lesion 1 is considered as non-target, lesion 2 is considered as target for PVI. A stent was implant into the left femoral-popliteal graft to correct the stenosis caused by the lesion (Lesion 2).

Below procedure data show

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Row

STUDYID

DOMAIN

USUBJID

PRSEQ

PRTRT

PRCATVISITNUM

VISIT

PRDTCPRSTDTCPRENDTC
 1

TUDY01

PR409121

cardiac catheterization

Prior Peripheral Artery Bypass Surgery1Baseline2007-01-01

2005-12-16T06:00

2005-12-16T09:00
2










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Row 1:Shows one or more lesions have been identified in the lower limb region.
Row 2:shows the native vessel that contains a lesion is the left femoro-popliteal peripheral artery.
Row 3:Shows the lesion is found in the left popliteal artery above the knee.
Row 4:Shows the graft vessel that contains a lesion is the femoro-popliteal graft.
Row 5:Shows the lesion is located in the proximal anastomosis (connection) of the graft.
Row 6:Shows the limb that contains lesion is the left leg.
Row 7:Shows the lesion in the native vessel is considered as non-target. In the context of clinical investigation, 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 graft vessel is considered as target. In the context of clinical investigation, a target vessel is any noncardiac or nonintracranial blood vessel that contains the target lesion treated with the study device.
Row 10:Shows the lesion in the graft vessel is considered 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. The target limb is the extremity that contains the target lesion and all the native vessels upstream and downstream from it, including side branches.

(Jordan: this data element is really terrible, because a graft lesion can be a target lesion if deemed treatable by PVI, so the limb that contains a graft lesion would also be considered as a target limb. I hate common data elements, i think this test should just be removed from the dataset because the original source is really terrible.)

Row Captions Debug Message

Please capitalize the first letter of each row caption.

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Row

STUDYID

DOMAIN

USUBJID

TUSEQTULNKID

TUTEST

TULOC

TULATTULOCDTL

TUORRES

TUSTRESCTU Result LOCTU Result LATTU Result LOCDTL

TUMETHOD

TUEVEL

VISITNUM

VISIT

TUDTC

1

TUDY01

TU409121
Lesion IndicatorLOWER LIMB REGION

YY


PERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
2

TUDY01

TU409122Limb 1Limb with Lesion Location IdentificationLOWER LIMB REGION

LOCATEDLOCATEDLEGLEFT
PERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
3

TUDY01

TU409123Vessel 1-Lesion 1Vessel with Lesion Location IdentificationLOWER LIMB REGION

LOCATEDLOCATEDFEMORO-POPLITEAL PERIPHERAL ARTERYLEFT
PERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
4

TUDY01

TU409124Lesion 1Lesion Location IdentificationLOWER LIMB REGION

LOCATEDLOCATEDPOPLITEAL ARTERYLEFTABOVE KNEEPERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
5

TUDY01

TU409125Graft Vessel 1-Lesion 2Vessel with Lesion Location IdentificationLOWER LIMB REGION

LOCATEDLOCATEDLEFT FEMORO-POPLITEAL GRAFT

PERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
6

TUDY01

TU409126Lesion 2Lesion Location IdentificationLOWER LIMB REGION

LOCATEDLOCATEDLEFT FEMORO-POPLITEAL GRAFTGRAFT ANASTOMOSIS PROXIMAL5MM FROM THE ORIGIN OF THE GRAFTPERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
7

TUDY01

TU409126Lesion 2Graft Lesion Location IdentificationLEFT FEMORO-POPLITEAL GRAFT

LOCATEDLOCATEDGRAFT ANASTOMOSIS PROXIMAL

PERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
8

TUDY01

TU409127Limb 1Limb with Lesion Location IdentificationLOWER LIMB REGION

LOCATEDLOCATEDLEGLEFT
PERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
9

TUDY01

TU409128Vessel 1-Lesion 1Native Vessel with Lesion Role IdentificationFEMORO-POPLITEAL PERIPHERAL ARTERYLEFT
NON-TARGETNON-TARGET


PERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
10

TUDY01

TU409129Lesion 1

Lesion Role Identification

POPLITEAL ARTERYLEFTABOVE KNEENON-TARGETNON-TARGET


PERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
11

TUDY01

TU4091210Graft Vessel 1-Lesion 2Graft Vessel with Lesion Role IdentificationLEFT FEMORO-POPLITEAL GRAFTLEFT
TARGETTARGET


PERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
12

TUDY01

TU4091211Lesion 2Graft Lesion Role IdentificationLEFT FEMORO-POPLITEAL GRAFT
GRAFT ANASTOMOSIS PROXIMALTARGETTARGET


PERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
13

TUDY01

TU4091212Limb 1Limb with Lesion Role IdentificationLEGLEFT
TARGETTARGET


PERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
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Dataset Wrapper Debug Message

Please add a row column to your dataset.

Note these parameters have been mapped to TR in the published CV-endpoint TAUG, but i think they are "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 1:The target lesion in the graft did not fail according to XXXX.
Row 2:The target graft vessel did not fail according to XXX.
Row 3:The target graft vessel is patent according to XXX.
Row 4:The target limb did not fail according to XXXX.

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Row

STUDYID

DOMAIN

USUBJID

TRSEQTRGRPID

TRLNKID

TRTEST

TRORRES

TRSTRESC

TRMETHOD

VISITNUM

VISIT

CVDTC

1

TUDY01

TR409121TARGETLesion 2Lesion Failure IndicatorNNPERIPHERAL ANGIOGRAPHY2BASELINE2007-02-01
3

TUDY01

TR409123TARGETGraft Vessel 1-Lesion 2Vessel Failure IndicatorNNPERIPHERAL ANGIOGRAPHY2BASELINE2007-02-01
4

TUDY01

TR409124TARGETGraft Vessel 1-Lesion 2

Vessel Patency Indicator

YYPERIPHERAL ANGIOGRAPHY2BASELINE2007-02-01
5

TUDY01

TR409125TARGETLimb 1-Lesion 2Limb Failure IndicatorNNPERIPHERAL ANGIOGRAPHY2BASELINE2007-02-01
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Dataset Wrapper Debug Message

Please add a row column to your dataset.

I think this should be modeled in RS in the following fashion, similar to that of Tumor response to treatment modeling in RS.
Row 1:The target lesion in the graft did not fail treatment according to ACC/AHA Clinical Data Standards 2014.
Row 2:The target graft vessel did not fail treatment according to ACC/AHA Clinical Data Standards 2014.
Row 3:The target graft vessel is patent according to ACC/AHA Clinical Data Standards 2014.
Row 4:The target limb did not fail treatment according to ACC/AHA Clinical Data Standards 2014.

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Row

STUDYID

DOMAIN

USUBJID

RSSEQRSGRPID

RSLNKID

RSTEST

RSCATRSORRES

RSSTRESC

VISITNUM

VISIT

CVDTC

1

TUDY01

TR409121TARGETLesion 2Lesion Failure IndicatorACC/AHA Clinical Data Standards 2014NN2BASELINE2007-02-01
2

TUDY01

TR409121TARGETGraft Vessel 1-Lesion 2Vessel Failure IndicatorACC/AHA Clinical Data Standards 2014NN2BASELINE2007-02-01
3

TUDY01

TR409121TARGETGraft Vessel 1-Lesion 2

Vessel Patency Indicator

ACC/AHA Clinical Data Standards 2014YY2BASELINE2007-02-01
4

TUDY01

TR409121TARGETLimb 1-Lesion 2Limb Failure IndicatorACC/AHA Clinical Data Standards 2014NN2BASELINE2007-02-01
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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