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Dataset wrap
titlecv.xpt
NameTU


Rowcaps


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.)



Dataset2
hi1styleyellow
hi267
hi156
hi2styleaqua
tableidTU1


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
3
4

TUDY01

TU40912
3
4Lesion 1Lesion Location IdentificationLOWER LIMB REGION

LOCATEDLOCATEDPOPLITEAL ARTERYLEFTABOVE KNEEPERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
4
5

TUDY01

TU40912
4
5Graft Vessel 1-Lesion 2Vessel with Lesion Location IdentificationLOWER LIMB REGION

LOCATEDLOCATEDLEFT FEMORO-POPLITEAL GRAFT

PERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
5
6

TUDY01

TU40912
5
6Lesion 2Lesion Location IdentificationLOWER LIMB REGION

LOCATEDLOCATEDLEFT FEMORO-POPLITEAL GRAFTGRAFT ANASTOMOSIS PROXIMAL5MM FROM THE ORIGIN OF THE GRAFTPERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
5
7

TUDY01

TU40912
5
6Lesion 2Graft Lesion Location IdentificationLEFT FEMORO-POPLITEAL GRAFT

LOCATEDLOCATEDGRAFT ANASTOMOSIS PROXIMAL
6







8

TUDY01

TU40912
6
7Limb 1Limb with Lesion Location IdentificationLOWER LIMB REGION

LOCATEDLOCATEDLEGLEFT
PERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
7
9

TUDY01

TU40912
7
8Vessel 1-Lesion 1Native Vessel with Lesion Role IdentificationFEMORO-POPLITEAL PERIPHERAL ARTERYLEFT
NON-TARGETNON-TARGET


PERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
8
10

TUDY01

TU40912
8
9Lesion 1

Lesion Role Identification

POPLITEAL ARTERYLEFTABOVE KNEENON-TARGETNON-TARGET


PERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
9
11

TUDY01

TU40912
9
10Graft Vessel 1-Lesion 2Graft Vessel with Lesion Role IdentificationLEFT FEMORO-POPLITEAL GRAFTLEFT
TARGETTARGET


PERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
10
12

TUDY01

TU40912
10
11Lesion 2Graft Lesion Role IdentificationLEFT FEMORO-POPLITEAL GRAFT
GRAFT ANASTOMOSIS PROXIMALTARGETTARGET


PERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
11
13

TUDY01

TU40912
11
12Limb 1Limb with Lesion Role IdentificationLEGLEFT
TARGETTARGET


PERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01



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.

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