CDE Detailed Report

Disease: Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage
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CRF: Aneurysm Retreatment and Re-rupture

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CDE ID CDE Name Variable Name Definition Short Description Question Text Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guidance) Subdomain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C54438 Aneurysm rerupture after primary treatment indicator AneurysmReruptAfterPrmTxInd Indicator related to whether the aneurysm reruptured after
primary treatment was completed
Indicator related to whether the aneurysm reruptured after primary treatment was completed Aneurysm re-rupture after primary treatment has been completed: No;Yes No;Yes Alphanumeric

Re-rupture of the aneurysm after completed primary treatment. Rupture of further, previously untreated aneurysms (e.g. in case of multiple aneurysms) are not considered re-rupture. Hemorrhages during initial or follow-up treatment are also not considered re-ruptures.

Johnston SC, Dowd CF, Higashida RT, Lawton MT, Duckwiler GR, Gress DR; CARAT Investigators.Predictors of rehemorrhage after treatment of ruptured intracranial aneurysms: the Cerebral Aneurysm Rerupture After Treatment (CARAT)study. Stroke. 2008 Jan;39(1):120-5. PubMed PMID: 18048860. Adult;Pediatric Exploratory 1.00 2017-03-08 13:14:08 Aneurysm Retreatment and Re-rupture [php] [php_1]

Single Pre-Defined Value Selected

C54439 Aneurysm rerupture after primary treatment date AneurysmReruptAfterPrmTxDate Date when the aneurysm reruptured after primary treatment was completed Date when the aneurysm reruptured after primary treatment was completed Date of re-rupture: Date or Date & Time

The earliest day the physician/APN/PA documented re-rupture of the aneurysm after completed primary treatment.

Adult;Pediatric Exploratory 1.00 2017-03-08 13:14:08.0 Aneurysm Retreatment and Re-rupture [php] [php_1]

Free-Form Entry

C54440 Aneurysm retreatment after primary treatment indicator AneurysmRetreatAfterPrmTxInd Indicator related to whether there is a need for retreatment of the aneurysm following primary treatment Indicator related to whether there is a need for retreatment of the aneurysm following primary treatment Aneurysm retreatment required after primary treatment: No;Yes No;Yes Alphanumeric

Retreatment of a previously ruptured aneurysm.

Campi A, Ramzi N, Molyneux AJ, Summers PE, Kerr RS, Sneade M, Yarnold JA, Rischmiller J, Byrne JV. Retreatment of ruptured cerebral aneurysms in patients randomized by coiling or clipping in the International Subarachnoid Aneurysm Trial (ISAT). Stroke. 2007 May;38(5):1538-44. PubMed PMID: 17395870. Adult;Pediatric Exploratory 1.00 2017-03-08 13:14:08.0 Aneurysm Retreatment and Re-rupture [php] [php_1]

Single Pre-Defined Value Selected

C54441 Aneurysm retreatment after primary treatment date AneurysmRetreatAfterPrmTxDate Date when retreatment of the aneurysm following primary treatment occurred Date when retreatment of the aneurysm following primary treatment occurred Date of retreatment: Date or Date & Time

The earliest day the physician/APN/PA documented retreatment of the aneurysm after completed primary treatment following the ictus.

Adult;Pediatric Exploratory 1.00 2017-03-08 13:14:08.0 Aneurysm Retreatment and Re-rupture [php] [php_1]

Free-Form Entry

C54442 Aneurysm retreatment type AneurysmRetreatType Type of aneurysm retreatment Type of aneurysm retreatment Aneurysm retreatment type: Endovascular;Surgical Endovascular;Surgical Alphanumeric Adult;Pediatric Exploratory 1.00 2017-03-08 13:14:08.0 Aneurysm Retreatment and Re-rupture [php] [php_1]

Multiple Pre-Defined Values Selected

C54443 Aneurysm retreatment surgical type AneurysmRetreatSurgTyp Element related to type of surgical aneurysm retreatment Element related to type of surgical aneurysm retreatment If surgical: Bypass;Clipping;Trapping alone;Wrapping;Hunterian ligation alone;Other;Attempted/failed Bypass;Clipping;Trapping alone;Wrapping;Hunterian ligation alone;Other;Attempted/failed Alphanumeric

Surgery involves craniotomy and microsurgery, including one or more of the following: clipping, trapping, Hunterian ligation, bypass, or wrapping; attempted/failed includes all aneurysms which did not receive definitive treatment via one of the aforementioned modalities; "definitive" means that at the conclusion of the procedure the prevention of immediate re-rupture has been achieved.
A craniotomy was performed and one or more of the listed techniques was performed. Bypass includes some other treatment for the aneurysm, e.g. trapping.

Adult;Pediatric Exploratory 1.00 2017-03-08 13:14:08.0 Aneurysm Retreatment and Re-rupture [php] [php_1]

Single Pre-Defined Value Selected

C54444 Aneurysm retreatment endovascular type AneurysmRetreatEndovasTyp Element related to type of endovascular aneurysm retreatment Element related to type of endovascular aneurysm retreatment If endovascular: Coil;Coil with balloon remodeling;Stent only;Stent/coil;Vessel occlusion;Flow diverter;Other;Attempted/failed Coil;Coil with balloon remodeling;Stent only;Stent/coil;Vessel occlusion;Flow diverter;Other;Attempted/failed Alphanumeric

Endovascular treatment will include use of coils, stents, and/or other endovascular devices alone or in combination to occlude the aneurysm; attempted/failed includes all aneurysms, which did not receive definitive treatment via one of the aforementioned modalities; "definitive" means that at the conclusion of the procedure the prevention of immediate re-rupture has been achieved.
Type of endovascular repair described in detail including all endovascular devices utilized, alone or in combination. Flow diverters include all stent technology intended to alter flow into the aneurysm sac; stent in this context means a non-flow diverting stent.

Adult;Pediatric Exploratory 1.00 2017-03-08 13:14:08.0 Aneurysm Retreatment and Re-rupture [php] [php_1]

Single Pre-Defined Value Selected

CSV