DANCER: Study protocol of a prospective, non-randomized controlled trial for crossed limb versus standard limb configuration in endovascular abdominal aortic aneurysm repair
BackgroundHostile anatomy, especially severely angulated neck and tortuous iliac arteries, has always been a conundrum in endovascular aneurysm repair (EVAR). Crossed limb (CL) graft, also called the “ballerina technique,” has been utilized to address this problem by facilitating gate cannulation. I...
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2022-11-01
|
| Series: | Frontiers in Cardiovascular Medicine |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fcvm.2022.1046200/full |
| _version_ | 1828336840798633984 |
|---|---|
| author | Yinzhi Shen Jiarong Wang Jichun Zhao Ding Yuan Tiehao Wang Bin Huang |
| author_facet | Yinzhi Shen Jiarong Wang Jichun Zhao Ding Yuan Tiehao Wang Bin Huang |
| author_sort | Yinzhi Shen |
| collection | DOAJ |
| description | BackgroundHostile anatomy, especially severely angulated neck and tortuous iliac arteries, has always been a conundrum in endovascular aneurysm repair (EVAR). Crossed limb (CL) graft, also called the “ballerina technique,” has been utilized to address this problem by facilitating gate cannulation. In terms of short and long-term outcomes, correlated studies have made inconsistent conclusions and this issue remains controversial. Based on a previous cohort study conducted in our center, we aim to prospectively compare the safety and efficacy between CL and standard limb (SL) configuration in patients receiving EVAR.MethodsThis is a prospective, single-center, non-randomized controlled trial. A total of 275 patients who meet the inclusion criteria will be enrolled and allocated with a 4:11 ratio of CL to SL, which is based on results of our previous study. All patients will receive same perioperative management and postoperative medications. All EVAR procedures will be performed under standard protocol, utilizing Endurant II or IIs Stent Graft. The configuration of the graft stent will be decided by surgeons and confirmed by final angiography. The primary outcome is 3-year freedom from major adverse limb-graft events (MALEs). Endpoints will be assessed at the following time points: 1, 6, 12, 24, and 36 months.DiscussionTo our best knowledge, this crosseD vs. stANdard Configuration in Endovascular Repair (DANCER) trial is the first non-randomized controlled trial to compare these two graft configurations in EVAR. The main aim is to compare the MALEs between two groups at 3 years postoperatively. This trial will hopefully provide high-level evidence for employing CL in EVAR.Clinical trial registration[www.chictr.org.cn], identifier [ChiCTR2100053055]. |
| first_indexed | 2024-04-13T22:07:38Z |
| format | Article |
| id | doaj.art-ee13540c82a44441a48e705c901beddf |
| institution | Directory Open Access Journal |
| issn | 2297-055X |
| language | English |
| last_indexed | 2024-04-13T22:07:38Z |
| publishDate | 2022-11-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Cardiovascular Medicine |
| spelling | doaj.art-ee13540c82a44441a48e705c901beddf2022-12-22T02:27:54ZengFrontiers Media S.A.Frontiers in Cardiovascular Medicine2297-055X2022-11-01910.3389/fcvm.2022.10462001046200DANCER: Study protocol of a prospective, non-randomized controlled trial for crossed limb versus standard limb configuration in endovascular abdominal aortic aneurysm repairYinzhi Shen0Jiarong Wang1Jichun Zhao2Ding Yuan3Tiehao Wang4Bin Huang5West China School of Medicine, Sichuan University, Chengdu, ChinaDepartment of Vascular Surgery, West China Hospital, Sichuan University, Chengdu, ChinaDepartment of Vascular Surgery, West China Hospital, Sichuan University, Chengdu, ChinaDepartment of Vascular Surgery, West China Hospital, Sichuan University, Chengdu, ChinaDepartment of Vascular Surgery, West China Hospital, Sichuan University, Chengdu, ChinaDepartment of Vascular Surgery, West China Hospital, Sichuan University, Chengdu, ChinaBackgroundHostile anatomy, especially severely angulated neck and tortuous iliac arteries, has always been a conundrum in endovascular aneurysm repair (EVAR). Crossed limb (CL) graft, also called the “ballerina technique,” has been utilized to address this problem by facilitating gate cannulation. In terms of short and long-term outcomes, correlated studies have made inconsistent conclusions and this issue remains controversial. Based on a previous cohort study conducted in our center, we aim to prospectively compare the safety and efficacy between CL and standard limb (SL) configuration in patients receiving EVAR.MethodsThis is a prospective, single-center, non-randomized controlled trial. A total of 275 patients who meet the inclusion criteria will be enrolled and allocated with a 4:11 ratio of CL to SL, which is based on results of our previous study. All patients will receive same perioperative management and postoperative medications. All EVAR procedures will be performed under standard protocol, utilizing Endurant II or IIs Stent Graft. The configuration of the graft stent will be decided by surgeons and confirmed by final angiography. The primary outcome is 3-year freedom from major adverse limb-graft events (MALEs). Endpoints will be assessed at the following time points: 1, 6, 12, 24, and 36 months.DiscussionTo our best knowledge, this crosseD vs. stANdard Configuration in Endovascular Repair (DANCER) trial is the first non-randomized controlled trial to compare these two graft configurations in EVAR. The main aim is to compare the MALEs between two groups at 3 years postoperatively. This trial will hopefully provide high-level evidence for employing CL in EVAR.Clinical trial registration[www.chictr.org.cn], identifier [ChiCTR2100053055].https://www.frontiersin.org/articles/10.3389/fcvm.2022.1046200/fullnon-randomized controlled trialcrossed limbstandard limbEVARabdominal aortic aneurysm |
| spellingShingle | Yinzhi Shen Jiarong Wang Jichun Zhao Ding Yuan Tiehao Wang Bin Huang DANCER: Study protocol of a prospective, non-randomized controlled trial for crossed limb versus standard limb configuration in endovascular abdominal aortic aneurysm repair Frontiers in Cardiovascular Medicine non-randomized controlled trial crossed limb standard limb EVAR abdominal aortic aneurysm |
| title | DANCER: Study protocol of a prospective, non-randomized controlled trial for crossed limb versus standard limb configuration in endovascular abdominal aortic aneurysm repair |
| title_full | DANCER: Study protocol of a prospective, non-randomized controlled trial for crossed limb versus standard limb configuration in endovascular abdominal aortic aneurysm repair |
| title_fullStr | DANCER: Study protocol of a prospective, non-randomized controlled trial for crossed limb versus standard limb configuration in endovascular abdominal aortic aneurysm repair |
| title_full_unstemmed | DANCER: Study protocol of a prospective, non-randomized controlled trial for crossed limb versus standard limb configuration in endovascular abdominal aortic aneurysm repair |
| title_short | DANCER: Study protocol of a prospective, non-randomized controlled trial for crossed limb versus standard limb configuration in endovascular abdominal aortic aneurysm repair |
| title_sort | dancer study protocol of a prospective non randomized controlled trial for crossed limb versus standard limb configuration in endovascular abdominal aortic aneurysm repair |
| topic | non-randomized controlled trial crossed limb standard limb EVAR abdominal aortic aneurysm |
| url | https://www.frontiersin.org/articles/10.3389/fcvm.2022.1046200/full |
| work_keys_str_mv | AT yinzhishen dancerstudyprotocolofaprospectivenonrandomizedcontrolledtrialforcrossedlimbversusstandardlimbconfigurationinendovascularabdominalaorticaneurysmrepair AT jiarongwang dancerstudyprotocolofaprospectivenonrandomizedcontrolledtrialforcrossedlimbversusstandardlimbconfigurationinendovascularabdominalaorticaneurysmrepair AT jichunzhao dancerstudyprotocolofaprospectivenonrandomizedcontrolledtrialforcrossedlimbversusstandardlimbconfigurationinendovascularabdominalaorticaneurysmrepair AT dingyuan dancerstudyprotocolofaprospectivenonrandomizedcontrolledtrialforcrossedlimbversusstandardlimbconfigurationinendovascularabdominalaorticaneurysmrepair AT tiehaowang dancerstudyprotocolofaprospectivenonrandomizedcontrolledtrialforcrossedlimbversusstandardlimbconfigurationinendovascularabdominalaorticaneurysmrepair AT binhuang dancerstudyprotocolofaprospectivenonrandomizedcontrolledtrialforcrossedlimbversusstandardlimbconfigurationinendovascularabdominalaorticaneurysmrepair |