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)

NCT06639243 | Active Not Recruiting DMC FDA Device

• 1 other identifier: Qingwei Ding
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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 \< 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.

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

Outcome Measures

Primary Outcomes (1)

• Incidence of Major Adverse Events (MAE) Within 30 Days Post-Operation

  This primary outcome measure evaluates the safety of the Quick Yielding Modified (QYM) technique by assessing the incidence of major adverse events (MAE) occurring within 30 days following the surgical intervention. Major adverse events include any significant complications that could impact patient health and recovery, such as stroke, myocardial infarction, aortic rupture, organ failure, or death. The goal is to determine the short-term safety profile of the intervention, providing critical information on its clinical viability for patients with complex aortic arch diseases. Data will be collected through patient monitoring, clinical assessments, and medical records during the specified follow-up period.

  30 days post-operation

Secondary Outcomes (11)

• Aortic Treatment Success Rate at 12 Months

  Up to 12 months post-operation

• All-Cause Mortality

  Up to 12 months post-operation

• Aortic-Related Mortality

  Up to 12 months post-operation

• Incidence of Severe Adverse Events

  Up to 12 months post-operation

• Occurrence of Type I or III Endoleaks

  Up to 12 months post-operation

Study Arms (1)

QTM Technique Treatment Arm

EXPERIMENTAL

In this study, all participants will undergo the Quick Yielding Modified (QYM) technique, which combines thoracic endovascular aortic repair (TEVAR) with in situ fenestration and revascularization of the supra-aortic branches. This technique is designed to treat patients with complex aortic arch diseases, including thoracic aortic dissection, true and pseudoaneurysms, penetrating aortic ulcers, and intramural hematomas. The procedure aims to provide a minimally invasive alternative to open surgery, allowing for the effective reconstruction of the aortic arch and its branches. The study will assess the safety and efficacy of this technique, with key outcomes including the incidence of major adverse events (MAE) and the long-term success of the treatment.

Device: QYM Technique

Interventions

QYM Technique DEVICE

The intervention in this study involves the application of the Quick Yielding Modified (QYM) technique for the treatment of complex aortic arch diseases. This procedure consists of two main components: 1. Thoracic Endovascular Aortic Repair (TEVAR): This minimally invasive procedure utilizes a covered stent graft to exclude the diseased segment of the thoracic aorta, providing immediate protection against rupture and controlling blood flow. 2. In Situ Fenestration and Revascularization of Supra-Aortic Branches: Following TEVAR, the QYM technique includes creating fenestrations in the stent graft to allow for the revascularization of the supra-aortic branches (such as the brachiocephalic, left common carotid, and left subclavian arteries). This is achieved through direct puncture and reconstruction of the branch vessels, ensuring adequate blood flow to these critical arteries while preserving their function. The combination of these techniques aims to achieve effective treatment out

QTM Technique Treatment Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: Patients between 18 and 80 years of age.
• 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
• 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.
• Proximal Landing Zone: Patients whose proximal stent landing zone is in Zone 0 of the aortic arch.
• Aortic Anatomy:
• Length of ascending aorta \>4 cm (from the sinotubular junction to the proximal edge of the brachiocephalic artery).
• Diameter of ascending aorta between 24 mm and 44 mm.
• Access Vessel Anatomy:
• Iliac artery diameter ≥7 mm.
• Brachiocephalic artery diameter ≤24 mm, and length ≥20 mm.

You may not qualify if:

• Infection: Patients with systemic infections within the last 3 months.
• Recent Neck Surgery: Patients who underwent neck surgery within the past 3 months.
• Coronary Involvement: Patients with disease extending to the coronary arteries or aortic valve.
• Infectious or Autoimmune Diseases: Patients with conditions such as infectious aortic disease, large vessel vasculitis, or Marfan syndrome (or other connective tissue disorders).
• Severe Vascular Conditions: Patients with severe stenosis, calcification, thrombosis, or tortuosity of the carotid or subclavian arteries.
• Heart Transplant: Patients who have undergone heart transplantation.
• Recent Cardiac Events: Patients who had a myocardial infarction or stroke within the last 3 months.
• Advanced Heart Failure: Patients with New York Heart Association (NYHA) Class IV heart failure.
• Active Gastrointestinal Conditions: Patients with active peptic ulcer disease or upper gastrointestinal bleeding within the past 3 months.
• Hematologic Abnormalities:
• Leukopenia (white blood cell count \< 3×10⁹/L)
• Acute anemia (hemoglobin \< 90 g/L)
• Thrombocytopenia (platelet count \< 50×10⁹/L)
• History of bleeding disorders or coagulopathy.
• Renal Function: Patients with impaired renal function (creatinine \> 265 µmol/L) or those with end-stage renal disease.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Department of Vascular Surgery, General Surgery Clinical Center, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.

Shanghai, Shanghai Municipality, 200080, China

Location

Related Publications (3)

• 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.

  PMID: 32395281 BACKGROUND

• 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.

  PMID: 19962330 BACKGROUND

• 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.

  PMID: 35390485 BACKGROUND

MeSH Terms

Conditions

Dissection, Thoracic Aorta; Aortic Aneurysm, Thoracic; Penetrating Atherosclerotic Ulcer

Condition Hierarchy (Ancestors)

Aortic Dissection; Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases; Aortic Aneurysm; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Sub-PI

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)