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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pr.xpt
Row
STUDYID
DOMAIN
USUBJID
PRSEQ
PRTRT
PRCAT
VISITNUM
VISIT
PRDTC
PRSTDTC
PRENDTC
1
TUDY01
PR
40912
1
Bypass Graft
Prior Peripheral Artery Bypass Surgery
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?
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.
fa.xpt
fapr.xpt
Row
STUDYID
DOMAIN
USUBJID
FASEQ
FATEST
FAOBJ
FACAT
FAORRES
VISITNUM
VISIT
TUDTC
1
TUDY01
FA
40912
1
Graft Vessel Construction Location
Bypass Graft
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 Surgery
Cardaveric Graft, Venous
1
SCREEN
2007-01-01
3
TUDY01
FA
40912
3
Graft Anastomosis (connection) Location
Bypass Graft
Prior Peripheral Artery Bypass Surgery
Left Common femoral Artery
1
SCREEN
2007-01-01
4
TUDY01
FA
40912
4
Graft Anastomosis (connection) Location
Bypass Graft
Prior Peripheral Artery Bypass Surgery
Left Popliteal Artery
1
SCREEN
2007-01-01
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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pr.xpt
Row
STUDYID
DOMAIN
USUBJID
PRSEQ
PRTRT
PRCAT
VISITNUM
VISIT
PRDTC
PRSTDTC
PRENDTC
1
TUDY01
PR
40912
1
cardiac catheterization
Prior Peripheral Artery Bypass Surgery
1
Baseline
2007-01-01
2005-12-16T06:00
2005-12-16T09:00
2
$warningHtml
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.
tu.xpt
tu.xpt
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
1
TUDY01
TU
40912
1
Lesion Indicator
LOWER LIMB REGION
Y
Y
PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
BASELINE
2007-02-01
2
TUDY01
TU
40912
2
Limb 1
Limb with Lesion Location Identification
LOWER LIMB REGION
LOCATED
LOCATED
LEG
LEFT
PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
BASELINE
2007-02-01
3
TUDY01
TU
40912
3
Vessel 1-Lesion 1
Vessel with Lesion Location Identification
LOWER LIMB REGION
LOCATED
LOCATED
FEMORO-POPLITEAL PERIPHERAL ARTERY
LEFT
PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
BASELINE
2007-02-01
4
TUDY01
TU
40912
4
Lesion 1
Lesion Location Identification
LOWER LIMB REGION
LOCATED
LOCATED
POPLITEAL ARTERY
LEFT
ABOVE KNEE
PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
BASELINE
2007-02-01
5
TUDY01
TU
40912
5
Graft Vessel 1-Lesion 2
Vessel with Lesion Location Identification
LOWER LIMB REGION
LOCATED
LOCATED
LEFT FEMORO-POPLITEAL GRAFT
PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
BASELINE
2007-02-01
6
TUDY01
TU
40912
6
Lesion 2
Lesion Location Identification
LOWER LIMB REGION
LOCATED
LOCATED
LEFT FEMORO-POPLITEAL GRAFT
GRAFT ANASTOMOSIS PROXIMAL
5MM FROM THE ORIGIN OF THE GRAFT
PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
BASELINE
2007-02-01
7
TUDY01
TU
40912
6
Lesion 2
Graft Lesion Location Identification
LEFT FEMORO-POPLITEAL GRAFT
LOCATED
LOCATED
GRAFT ANASTOMOSIS PROXIMAL
PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
BASELINE
2007-02-01
8
TUDY01
TU
40912
7
Limb 1
Limb with Lesion Location Identification
LOWER LIMB REGION
LOCATED
LOCATED
LEG
LEFT
PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
BASELINE
2007-02-01
9
TUDY01
TU
40912
8
Vessel 1-Lesion 1
Native Vessel with Lesion Role Identification
FEMORO-POPLITEAL PERIPHERAL ARTERY
LEFT
NON-TARGET
NON-TARGET
PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
BASELINE
2007-02-01
10
TUDY01
TU
40912
9
Lesion 1
Lesion Role Identification
POPLITEAL ARTERY
LEFT
ABOVE KNEE
NON-TARGET
NON-TARGET
PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
BASELINE
2007-02-01
11
TUDY01
TU
40912
10
Graft Vessel 1-Lesion 2
Graft Vessel with Lesion Role Identification
LEFT FEMORO-POPLITEAL GRAFT
LEFT
TARGET
TARGET
PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
BASELINE
2007-02-01
12
TUDY01
TU
40912
11
Lesion 2
Graft Lesion Role Identification
LEFT FEMORO-POPLITEAL GRAFT
GRAFT ANASTOMOSIS PROXIMAL
TARGET
TARGET
PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
BASELINE
2007-02-01
13
TUDY01
TU
40912
12
Limb 1
Limb with Lesion Role Identification
LEG
LEFT
TARGET
TARGET
PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
BASELINE
2007-02-01
$warningHtml
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.
tr.xpt
tr.xpt
Row
STUDYID
DOMAIN
USUBJID
TRSEQ
TRGRPID
TRLNKID
TRTEST
TRORRES
TRSTRESC
TRMETHOD
VISITNUM
VISIT
CVDTC
1
TUDY01
TR
40912
1
TARGET
Lesion 2
Lesion Failure Indicator
N
N
PERIPHERAL ANGIOGRAPHY
2
BASELINE
2007-02-01
3
TUDY01
TR
40912
3
TARGET
Graft Vessel 1-Lesion 2
Vessel Failure Indicator
N
N
PERIPHERAL ANGIOGRAPHY
2
BASELINE
2007-02-01
4
TUDY01
TR
40912
4
TARGET
Graft Vessel 1-Lesion 2
Vessel Patency Indicator
Y
Y
PERIPHERAL ANGIOGRAPHY
2
BASELINE
2007-02-01
5
TUDY01
TR
40912
5
TARGET
Limb 1-Lesion 2
Limb Failure Indicator
N
N
PERIPHERAL ANGIOGRAPHY
2
BASELINE
2007-02-01
$warningHtml
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.