Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639243
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
Quick Yielding Modified Short-Distance Fenestration Technique for the Treatment of Complex Aortic Arch Diseases a Multicenter Single-Arm Objective Performance Criteria TrialQYM-Tech Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Quick Yielding Modified Short-Distance Fenestration Technique for the Treatment of Complex Aortic Arch Diseases a Multicenter Single-Arm Objective Performance Criteria Trial QYM-Tech Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background This study investigates the safety and efficacy of a novel surgical approach combining thoracic endovascular aortic repair TEVAR and in situ fenestration reconstruction of supra-aortic branches using the Quick Yielding Modified QYM technique This procedure aims to address complex aortic arch diseases providing an alternative to more invasive open surgical interventions
Methods This is a prospective multicenter single-arm interventional study involving 87 patients across 3 centers Eligible participants are adults aged 18-80 diagnosed with thoracic aortic dissection thoracic aortic aneurysm true or pseudo penetrating aortic ulcer or intramural hematoma necessitating supra-aortic branch vessel reconstruction The surgical protocol involves TEVAR combined with the QYM technique for fenestration and revascularization
Primary Outcome The primary endpoint is the incidence of major adverse events MAE within 30 days post-operation
Secondary Outcomes Secondary endpoints include 12-month aortic treatment success all-cause mortality aortic-related mortality incidence of severe adverse events occurrence of Type IIII endoleaks stent graft migration patency of revascularized branches and rates of conversion to open surgery or reintervention due to aortic complications
InclusionExclusion Criteria Key inclusion criteria include imaging-confirmed thoracic aortic disease requiring endovascular repair with a proximal landing zone in the aortic arch Zone 0 and suitable anatomical features for stent placement Patients with recent systemic infections severe coronary artery involvement or other significant comorbidities were excluded
Follow-up and Statistical Analysis Patients will undergo follow-ups at discharge 30 days 6 months and 12 months post-surgery Statistical analyses will include descriptive statistics of quantitative and categorical variables with statistical significance set at a one-sided p-value lt 0025
This study aims to provide critical insights into the clinical applicability of the QYM technique potentially broadening therapeutic options for complex aortic arch diseases
Methods This is a prospective multicenter single-arm interventional study involving 87 patients across 3 centers Eligible participants are adults aged 18-80 diagnosed with thoracic aortic dissection thoracic aortic aneurysm true or pseudo penetrating aortic ulcer or intramural hematoma necessitating supra-aortic branch vessel reconstruction The surgical protocol involves TEVAR combined with the QYM technique for fenestration and revascularization
Primary Outcome The primary endpoint is the incidence of major adverse events MAE within 30 days post-operation
Secondary Outcomes Secondary endpoints include 12-month aortic treatment success all-cause mortality aortic-related mortality incidence of severe adverse events occurrence of Type IIII endoleaks stent graft migration patency of revascularized branches and rates of conversion to open surgery or reintervention due to aortic complications
InclusionExclusion Criteria Key inclusion criteria include imaging-confirmed thoracic aortic disease requiring endovascular repair with a proximal landing zone in the aortic arch Zone 0 and suitable anatomical features for stent placement Patients with recent systemic infections severe coronary artery involvement or other significant comorbidities were excluded
Follow-up and Statistical Analysis Patients will undergo follow-ups at discharge 30 days 6 months and 12 months post-surgery Statistical analyses will include descriptive statistics of quantitative and categorical variables with statistical significance set at a one-sided p-value lt 0025
This study aims to provide critical insights into the clinical applicability of the QYM technique potentially broadening therapeutic options for complex aortic arch diseases
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None