Clinical trial NCT06639243: 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)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Thoracic Aortic Dissection
Thoracic Aortic Aneurysm (true Aneurysm)
Thoracic Pseudoaneurysm
Penetrating Aortic Ulcer
Intramural Hematoma of the Thoracic Aorta
Keywords: Complex aortic arch diseases
Thoracic aortic dissection
Thoracic aortic aneurysm
Penetrating aortic ulcer
Quick Yielding Modified (QYM) technique
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 I/III endoleaks, stent graft migration, patency of revascularized branches, and rates of conversion to open surgery or reintervention due to aortic complications.

Inclusion/Exclusion 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; 0.025.

This study aims to provide critical insights into the clinical applicability of the QYM technique, potentially broadening therapeutic options for complex aortic arch diseases.


Eligibility criteria: Inclusion Criteria:

1. Age: Patients between 18 and 80 years of age.
2. Diagnosis: Patients with the following thoracic aortic conditions confirmed by imaging (CTA):

   * Thoracic aortic dissection
   * True thoracic aortic aneurysm
   * Thoracic pseudoaneurysm
   * Penetrating aortic ulcer
   * Intramural hematoma
3. Indication for Treatment: Patients requiring supra-aortic branch vessel reconstruction due to rupture, impending rupture, malperfusion syndrome, rapid expansion, uncontrolled pain, aneurysmal dilation, or for prophylactic reasons.
4. Proximal Landing Zone: Patients whose proximal stent landing zone is in Zone 0 of the aortic arch.
5. Aortic Anatomy:

   * Length of ascending aorta \&gt;4 cm (from the sinotubular junction to the proximal edge of the brachiocephalic artery).
   * Diameter of ascending aorta between 24 mm and 44 mm.
6. Access Vessel Anatomy:

   * Iliac artery diameter ≥7 mm.
   * Brachiocephalic artery diameter ≤24 mm, and length ≥20 mm.
7. Informed Consent: Patients who have been informed about the nature of the study and agreed to participate by signing the informed consent form.

Exclusion Criteria:

1. Infection: Patients with systemic infections within the last 3 months.
2. Recent Neck Surgery: Patients who underwent neck surgery within the past 3 months.
3. Coronary Involvement: Patients with disease extending to the coronary arteries or aortic valve.
4. Infectious or Autoimmune Diseases: Patients with conditions such as infectious aortic disease, large vessel vasculitis, or Marfan syndrome (or other connective tissue disorders).
5. Severe Vascular Conditions: Patients with severe stenosis, calcification, thrombosis, or tortuosity of the carotid or subclavian arteries.
6. Heart Transplant: Patients who have undergone heart transplantation.
7. Recent Cardiac Events: Patients who had a myocardial infarction or stroke within the last 3 months.
8. Advanced Heart Failure: Patients with New York Heart Association (NYHA) Class IV heart failure.
9. Active Gastrointestinal Conditions: Patients with active peptic ulcer disease or upper gastrointestinal bleeding within the past 3 months.
10. Hematologic Abnormalities:

    * Leukopenia (white blood cell count \&lt; 3×10⁹/L)
    * Acute anemia (hemoglobin \&lt; 90 g/L)
    * Thrombocytopenia (platelet count \&lt; 50×10⁹/L)
    * History of bleeding disorders or coagulopathy.
11. Renal Function: Patients with impaired renal function (creatinine \&gt; 265 µmol/L) or those with end-stage renal disease.
12. Pregnancy or Lactation: Pregnant or breastfeeding women.
13. Allergy to Contrast Media: Patients with an allergy to the contrast agents used in imaging.
14. Life Expectancy: Patients with an expected survival of less than 12 months.
15. Concurrent Research Participation: Patients involved in other drug or device trials.
16. Other Medical Conditions: Any other disease or condition that, in the opinion of the investigator, may interfere with the endovascular treatment or the patient's ability to participate in the study.

Primary outcomes:
measure: Incidence of Major Adverse Events (MAE) Within 30 Days Post-Operation
timeFrame: 30 days post-operation
Secondary outcomes:
measure: Aortic Treatment Success Rate at 12 Months
timeFrame: Up to 12 months post-operation
measure: All-Cause Mortality
timeFrame: Up to 12 months post-operation
measure: Aortic-Related Mortality
timeFrame: Up to 12 months post-operation
measure: Incidence of Severe Adverse Events
timeFrame: Up to 12 months post-operation
measure: Occurrence of Type I or III Endoleaks
timeFrame: Up to 12 months post-operation
measure: Rate of Stent Graft Migration
timeFrame: Up to 12 months post-operation
measure: Patency Rate of Revascularized Branch Vessels
timeFrame: Up to 12 months post-operation
measure: Rate of Conversion to Open Surgery or Reintervention Due to Aortic Complications
timeFrame: Up to 12 months post-operation
measure: Incidence of Major Adverse Events (MAE) at 12 Months
timeFrame: 12 months post-operation
measure: Freedom from Aortic Rupture
timeFrame: 12 months post-operation
measure: Freedom from Reintervention
timeFrame: 12 months post-operation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Vascular Surgery, General Surgery Clinical Center, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
state: Shanghai
Study officials:
References:
citation: Shu C, Fan B, Luo M, Li Q, Fang K, Li M, Li X, He H, Wang T, Yang C, Xue Y, Gao H, Zhao J. Endovascular treatment for aortic arch pathologies: chimney, on-the-table fenestration, and in-situ fenestration techniques. J Thorac Dis. 2020 Apr;12(4):1437-1448. doi: 10.21037/jtd.2020.03.10.
citation: Matsuda H, Fukuda T, Iritani O, Nakazawa T, Tanaka H, Sasaki H, Minatoya K, Ogino H. Spinal cord injury is not negligible after TEVAR for lower descending aorta. Eur J Vasc Endovasc Surg. 2010 Feb;39(2):179-86. doi: 10.1016/j.ejvs.2009.11.014. Epub 2009 Dec 3.
citation: Wang J, Jin T, Chen B, Pan Y, Shao C. Systematic review and meta-analysis of current evidence in endograft therapy vs medical treatment for uncomplicated type B aortic dissection. J Vasc Surg. 2022 Oct;76(4):1099-1108.e3. doi: 10.1016/j.jvs.2022.03.876. Epub 2022 Apr 4.