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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).

Dataset wrap
titlecv.xpt
NamePR


PRIOR SURGERY
Dataset2


Row

STUDYID

DOMAIN

USUBJID

PRREFIDPRSEQ

PRTRT

PRLOCPRLATPRCATVISITNUM

VISIT

PRDTCPRSTDTCPRENDTC
 1

TUDY01

PR40912graft011
CORONARY ARTERY BYPASS GRAFT

Peripheral Artery Bypass Graft

Femoral-popliteal ArteryLeftPrior Intervention1SCREEN2007-01-01

2005-12-16T06:00

2005-12-16T09:00



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.
Dataset wrap
titlecv.xpt
Namefapr


Rowcaps


Row 1:Shows the graft vessel was built on the
LEFT FEMORO-POPLITEAL ARTERY
Left Femoral-popliteal Artery.
Row 2:Shows the bypass graft type was venous cadaveric graft, which is composed of a
artery
vein harvested from a cadaver.
Rows 3-4:Show the graft anastomoses (connections) to the
LEFT FEMORO-POPLITEAL ARTERY
Left Femoral-popliteal Artery were on the
LEFT COMMON FEMORAL ARTERY and LEFT POPLITEAL ARTERY
Left Common femoral Artery and Left Popliteal Artery.



Dataset2
hi2styleyellow


Row

STUDYID

DOMAIN

USUBJID

FAREFIDFASEQ

FATEST

FAOBJFACATFAORRES

VISITNUM

VISIT

TUDTC

12TUDY01FA409121Graft Construction LocationCORONARY ARTERY BYPASS GRAFTPRIOR SURGERYLEFT FEMORO-POPLITEAL ARTERY1SCREEN2007-01-01graft0122TUDY01FA409122

Bypass Graft Type

CORONARY ARTERY BYPASS GRAFTPRIOR SURGERYPeripheral Artery Bypass GraftPrior Intervention

Cadaveric Graft, VenousCADAVERIC GRAFT, VENOUS

1SCREEN2007-01-01
3TUDY01FA40912graft013Proximal Graft Anastomosis (connection) LocationCORONARY ARTERY BYPASS GRAFTPRIOR SURGERYPeripheral Artery Bypass GraftPrior InterventionCommon femoral ArteryLEFT COMMON FEMORAL ARTERY1SCREEN2007-01-01
4TUDY01FA40912graft014

Distal Graft Anastomosis (connection) Location

CORONARY ARTERY BYPASS GRAFTPRIOR SURGERYPeripheral Artery Bypass GraftPrior InterventionPopliteal ArteryLEFT POPLITEAL ARTERY1SCREEN2007-01-01

Two lesions are located



On 2007-01-03, the subject had undergone 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 1) was located in the left femoral-popliteal graft. While Lesion 1 is considered as non-target, graft lesion 1 is considered as target for the subsequent PVI treatment. On 2007-01-05, a stent was implanted into the left femoral-popliteal graft to correct the stenosis caused by the lesion (graft lesion 1). Note this information is collected on 2007-02-07 during VISIT 1.

Below procedure data show cardiac catheterization and stent implantation.

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.)
Dataset wrap
titlecv.xpt
NamePR
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:


Dataset2


Row

STUDYID

DOMAIN

USUBJID

TUSEQ
PRSEQ
TULNKID

PRTRT

TUTEST
PRCAT
TULOC
PRLOC
TULAT
VISITNUM
TULOCDTL

VISIT

TUORRES
PRDTC
TUSTRESCTURESLOC
TURESLATTURLOCDL

TUMETHOD

TUEVEL

VISITNUM

VISIT

TUDTC

PRSTDTCPRENDTC
1

TUDY01

TU
PR409121
Lesion IndicatorLOWER LIMB REGIONYY
CT PERIPHERAL ANGIOGRAPHYDIAGNOSTIC
INVESTIGATOR
LOWER EXTREMITIES2
BASELINE
VISIT 12007-02-
012

TUDY01

TU409122Vessel 1-Lesion 1Native Vessel with Lesion Location IdentificationLOWER LIMB REGIONLOCATEDLOCATEDFEMORO-POPLITEAL PERIPHERAL ARTERYLEFTPERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
07

2007-01-03T08:00

2007-01-03T09:00

TUDY01

PR409122CT PERIPHERAL ANGIOGRAPHYPVI
2VISIT 1
3

TUDY01

TU409123Lesion 1Lesion Location IdentificationLOWER LIMB REGIONLOCATEDLOCATEDPOPLITEAL ARTERYLEFTABOVE KNEEPERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE
2007-02-
014

TUDY01

TU409124Graft Vessel 1-Lesion 2Graft Vessel with Lesion Location IdentificationLOWER LIMB REGIONLOCATEDLOCATEDLEFT FEMORO-POPLITEAL GRAFTPERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-015

TUDY01

TU409125Lesion 2Graft Lesion Location IdentificationLEFT FEMORO-POPLITEAL GRAFTLOCATEDLOCATEDGRAFT ANASTOMOSIS PROXIMAL5MM FROM THE ORIGIN OF THE GRAFTPERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-016

TUDY01

TU409126Limb 1Limb with Lesion Location IdentificationLOWER LIMB REGIONLOCATEDLOCATEDLEGLEFTPERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-017

TUDY01

TU409127Vessel 1-Lesion 1Native Vessel with Lesion Role IdentificationFEMORO-POPLITEAL PERIPHERAL ARTERYLEFTNON-TARGETNON-TARGETPERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-018

TUDY01

TU409128Lesion 1

Lesion Role Identification

POPLITEAL ARTERYLEFTABOVE KNEENON-TARGETNON-TARGETPERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-019

TUDY01

TU409129Graft Vessel 1-Lesion 2Graft Vessel with Lesion Role IdentificationLEFT FEMORO-POPLITEAL GRAFTLEFTTARGETTARGETPERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-0110

TUDY01

TU4091210Lesion 2Graft Lesion Role IdentificationLEFT FEMORO-POPLITEAL GRAFTGRAFT ANASTOMOSIS PROXIMALTARGETTARGETPERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-0111

TUDY01

TU4091211Limb 1Limb with Lesion Role IdentificationLEGLEFTTARGETTARGETPERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
07

2007-01-05T07:00

2007-01-05T09:00
2

TUDY01

PR409123

Cardiac Catheterization

PVI
2VISIT 12007-02-07

2007-01-05T07:00

2007-01-05T09:00
3

TUDY01

PR409124Stent ImplantationPVI
2VISIT 12007-02-07

2007-01-05T07:00

2007-01-05T09:00



Lesion Type and Location Identification


Expand
titlePeripheral Artery Lesion CRF

Include Page
CDASH for Peripheral Arterial Lesion
CDASH for Peripheral Arterial Lesion

The below data show lesion location identification from the diagnostic CT peripheral angiography procedureNote 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.

Dataset wrap
titlecv.xpt
NameTRTU


Rowcaps


Row 1:The target lesion in the graft did not fail according to XXXXShows one or more lesions have been identified in the lower limb region.
Row 2:The target graft vessel did not fail according to XXXShows lesion 1 is identified in the left popliteal artery above the knee.
Row 3:The target graft vessel is patent according to XXX.
Row 4:The target limb did not fail according to XXXX.
Shows graft lesion 1 is located in the femoro-popliteal artery graft. 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.



Dataset2
Dataset2
hi1style#e3fcef
hi1TRLOC
tableidTR1


Row

STUDYID

DOMAIN

USUBJID

TRSEQ
TUSEQ
TRGRPID
TUREFID
TRLNKID
TULNKID
TRTEST
TUTESTCD
TRORRES

TUTEST

TRSTRESC

TULOC

TRMETHOD

TUORRES

VISITNUM
TUSTRESC
VISIT
TURESLOC
CVDTC
TURESLAT
1
RLODTL
TUDY01

TUMETHOD

TR
TUEVEL
40912

VISITNUM

1

VISIT

TARGET

TUDTC

Lesion 2Lesion Failure IndicatorNNPERIPHERAL ANGIOGRAPHY2BASELINE2007-02-013

TUDY01


TURLGFFL
1

TUDY01

TU
TR
40912
3
1
TARGET


LESIONIND
Graft Vessel 1-
Lesion
2		Vessel Failure IndicatorNNPERIPHERAL ANGIOGRAPHY2BASELINE2007-02-014

TUDY01

TR409124TARGETGraft Vessel 1-Lesion 2

Vessel Patency Indicator

IndicatorLOWER LIMB REGION
YY


CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2
BASELINE
VISIT 12007-02-
01
07
5


2

TUDY01

TR
TU40912
5
2
TARGETLimb 1-Lesion 2Limb Failure IndicatorNNPERIPHERAL ANGIOGRAPHY2BASELINE2007-02-01

I think this should be modeled in RS in the following fashion, similar to that of Tumor response to treatment modeling in RS.

...

titlecv.xpt
NameRS

...


Lesion 1ABNEXAMExamination for AbnormalityLOWER LIMB REGIONLESIONLESIONPOPLITEAL ARTERYLEFTABOVE KNEECT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07

3

TUDY01

TU409123graft01Graft Lesion 1ABNEXAMExamination for AbnormalityLOWER LIMB REGIONLESIONLESIONFEMORO-POPLITEAL ARTERYLEFTPROXIMAL ANASTOMOSIS, 5MM FROM THE ORIGIN OF THE GRAFTCT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
Y



Nsvmeta
DomainTU


VariableLabelTypeRoleOrigin
TURLGFFLResult location is Graft FlagtextNon-Standard Record QualifierCRF




Attachments

...

Row

...

STUDYID

...

DOMAIN

...

USUBJID

...

RSLNKID

...

RSTEST

...

RSSTRESC

...

VISITNUM

...

VISIT

...

CVDTC

...

TUDY01

...

TUDY01

...

TUDY01

...

Vessel Patency Indicator

...

TUDY01

...