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This trial aims to demonstrate the safety and validity of extracorporeal fenestration and in situ fenestration in patients with aortic disease involving the left subclavian artery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A(extracorporeal fenestration) | Experimental | Based on the preoperative CTA reconstructions, the diameter of the aorta and branch vessels, lengths, angles to the arch, clock positions, and related relationships are measured, and a preoperative design for the fenestrations is developed. The outer sheath of the stent graft is then pushed back for several centimeters under sterile conditions, allowing the proximal portion of the stent graft to be released. The length of the released segment should be one to two centimeters distal from the location of fenestration. Using a sterile ruler, the location of the fenestration is determined in accordance with the preoperative plan. The 12 o'clock position is considered to be at the front of the trigger. The position of the stent graft relative to the trigger is also referred to as the 12 o'clock position. If the fenestration must avoid stent struts, then the fenestration is deemed to be at 12 o'clock, as is the position of the trigger relative to the stent graft. |
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| B(In situ fenestration) | Sham Comparator | From the left brachial artery (LBA), a 6F angle-adjustable sheath (Lifetech, Inc., Shenzhen, China) is introduced retrogradely until its tip reaches the aortic stent graft. The tip is then adjusted to be as perpendicular as possible to the larger curve of the aortic stent graft. Once the sheath gets to the ideal position, a flexible needle (21 gauge, Futhrough, Lifetech, Inc.) is employed to create the fenestration in the aortic stent graft. Following the puncture, a 0.018-inch guidewire (V-18 ControlWire; Boston Scientific, Natick, MA) is inserted through the needle aperture and into the ascending aorta. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fenestration | Procedure | Thoracic EndoVascular Aortic Repair (TEVAR) with fenestrations |
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| Measure | Description | Time Frame |
|---|---|---|
| all-cause mortality | all-cause mortality | 1 month postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of endoleak | incidence of endoleak | postoperative (1, 6,12 months) |
| incidence of secondary intervention | incidence of secondary intervention |
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Inclusion Criteria:(All of the following criteria were met for enrolment):
Exclusion Criteria:(If any of the following criteria is met):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanbo Lou | Contact | 15088201610 | yanbo_lou@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yanbo Lou | The Fourth Affiliated Hospital Zhejiang University School of Medicine | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39885531 | Derived | Jia X, Wu J, Ding C, Lou Y. Safety and validity of extracorporeal fenestration and in situ fenestration in patients with aortic disease involving the left subclavian artery: a prospective, single-center, randomized controlled study. Trials. 2025 Jan 30;26(1):33. doi: 10.1186/s13063-025-08746-5. |
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Upon reasonable request, the corresponding author will provide access to the full protocol, participant level-data and statistical code
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| postoperative (1, 6,12 months) |
| incidence of major adverse events (MAE) | incidence of major adverse events (MAE) | postoperative (1, 6,12 months) |
| immediate technical success rate | immediate technical success rate | immediate postoperative |
| all-cause mortality | all-cause mortality | postoperative (6, 12 months) |
| ID | Term |
|---|---|
| D000784 | Aortic Dissection |
| ID | Term |
|---|---|
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000094683 | Acute Aortic Syndrome |
| D001018 | Aortic Diseases |
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| ID | Term |
|---|---|
| D005276 | Fenestration, Labyrinth |
| ID | Term |
|---|---|
| D013506 | Otologic Surgical Procedures |
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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