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 or remove the PRCATwith Prior Intervention. This information is collected during the SCREEN visit on 2007-01-01 (PRDTC).
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
Row | STUDYID | DOMAIN | USUBJID | PRREFID | PRSEQ | PRTRT | PRLOC | PRLAT | PRCAT | VISITNUM | VISIT | PRDTC | PRSTDTC | PRENDTC |
|---|
| 1 | TUDY01 | PR | 40912 | graft01 | 1 | Peripheral Artery Bypass Graft |
|---|
Prior Peripheral Artery Bypass Surgery| Femoral-popliteal Artery | Left | Prior Intervention | 1 | SCREEN | 2007-01-01 | 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:
- 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.
...
- .
...
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
| 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 a vein harvested from a cadaver. |
|---|
| 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. |
|---|
|
| Dataset2 |
|---|
|
Row | STUDYID | DOMAIN | USUBJID | FAREFID | FASEQ | FATEST | FAOBJ | FACAT | FAORRES | VISITNUM | VISIT | TUDTC |
|---|
| 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 Surgery | Prior Intervention | Cadaveric Cardaveric Graft, Venous | 1 | SCREEN | 2007-01-01 |
|---|
| 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 |
|---|
| 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 |
|---|
|
|
On 2007-0201-01, during the Peripheral Vascular Intervention (PVI) procedure 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 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). graft lesion 1). Note this information is collected on 2007-02-07 during VISIT 1.
Below procedure data show cardiac catheterization and stent implantation.
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
Row | STUDYID | DOMAIN | USUBJID | PRSEQ | PRTRT | PRCAT | PRLOC | VISITNUM | VISIT | PRDTC | PRSTDTC | PRENDTC |
|---|
1cardiac catheterization | Prior Peripheral Artery Bypass Surgery | 1 | Baseline | 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 |
|---|
2005-12-16T06| -05T09:00 | | 2 | TUDY01 | PR | 40912 | 3 | Cardiac Catheterization | PVI |
| 2 | VISIT 1 | 2007-02-07 | 2007-01-05T07:00 |
|---|
20051216T09| 05T09:00 | | 3 | TUDY01 | PR | 40912 | 4 | Stent Implantation | PVI |
| 2 | VISIT 1 | 2007-02-07 | 2007-01-05T07:00 | 2007-01-05T09:00 |
|---|
|
|
Lesion Type and Location Identification
| Expand |
|---|
| title | Peripheral 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 procedure.
| Dataset wrap |
|---|
|
| 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 1 is found identified in the left popliteal artery above the knee. |
|---|
| Row 43: | Shows the graft vessel that contains a lesion 1 is located in the femoro-popliteal artery 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.) |
|---|
| 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 | yellow |
|---|
| hi2 | 7 |
|---|
| hi1 | 6 |
|---|
| hi2style | aqua |
|---|
| tableid | TU1 |
|---|
|
| Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TUREFID | TULNKID | TUTESTCD | TUTEST | TULOC |
|---|
TULAT | TULOCDTLTU Result LOC | TU Result LAT | TU Result LOCDTL| TURESLOC | TURESLAT | RLODTL | TUMETHOD | TUEVEL | VISITNUM | VISIT | TUDTC |
| TURLGFFL |
|---|
| 1 | TUDY01 | TU | 40912 | 1 |
|
| LESIONIND | Lesion Indicator | LOWER LIMB REGION | Y | Y |
|
|
| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 |
|---|
BASELINE01Limb 1Limb with Location IdentificationLOWER LIMB REGION | LOCATED | LOCATED | LEG | LEFT | PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | BASELINE | 2007-02-01 | 3 | TUDY01 | TU | 40912 | 3 | Vessel 4 | TUDY01 | TU | 40912 | 4 | Lesion 1 | Lesion Location Identification | -Lesion 1Vessel with Lesion Location Identification | LOWER LIMB REGION | LOCATED | LOCATED | FEMORO-POPLITEAL PERIPHERAL ARTERY | LEFT | PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | BASELINE | 2007-02-01 | | ABNEXAM | Examination for Abnormality |
LOCATEDLOCATED| LESION | POPLITEAL ARTERY | LEFT | ABOVE KNEE | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 |
BASELINE0155 Vessel 1-Lesion 2| Lesion 1 | ABNEXAM | Examination for Abnormality |
Vessel with Lesion Location IdentificationLOCATEDLOCATEDLEFT GRAFT| ARTERY | LEFT | PROXIMAL ANASTOMOSIS, |
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 | CT 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 | 019TUDY01 | 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 | |
|
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.
...
...
| Nsvmeta |
|---|
|
| Variable | Label | Type | Role | Origin |
|---|
| TURLGFFL | Result location is Graft Flag | text | Non-Standard Record Qualifier | CRF |
|
|
...
| hi1style | #e3fcef |
|---|
| hi1 | TRLOC |
|---|
| tableid | TR1 |
|---|
...
Row
...
STUDYID
...
DOMAIN
...
USUBJID
...
TRLNKID
...
TRTEST
...
TRORRES
...
TRMETHOD
...
VISITNUM
...
VISIT
...
CVDTC
...
TUDY01
...
TUDY01
...
TUDY01
...
Vessel Patency Indicator
...
TUDY01
...
I think this should be modeled in RS in the following fashion, similar to that of Tumor response to treatment modeling in RS.
...
...
Row
...
STUDYID
...
DOMAIN
...
USUBJID
...
RSLNKID
...
RSTEST
...
RSSTRESC
...
VISITNUM
...
VISIT
...
CVDTC
...
TUDY01
...
TUDY01
...
TUDY01
...
Vessel Patency Indicator
...
TUDY01
...