A Triple-branched Stent Graft for Aute Debakey Type I Dissection Surgery

NCT06492980 | Recruiting

• 1 other identifier: A202101
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, multicenter, randomized controlled clinical trial plan to evaluate the effectiveness and safety of intraoperative stent system in the treatment of acute type I aortic dissection

Conditions

Acute Aortic Dissection

Outcome Measures

Primary Outcomes (1)

• Mortality within 30days post-operation

  Mortality within 30days post-operation

  30 days

Secondary Outcomes (3)

• Aortic dissection-related death occurred within 12 months after surgery

  12 month

• Thrombosis of the false lumen of the arch and proximal descending aorta

  12 month

• Technical success

  12 month

Study Arms (2)

Triple-branched stent graft group

EXPERIMENTAL

The device in this clinical trial implanted covered stents in the aortic arch, three branches, and descending thoracic aorta, replacing surgical anastomosis with interventional treatment.

Procedure: triple-branched stent graft

Aortic arch replacement with frozen elephant trunk

ACTIVE COMPARATOR

This surgical method is ascending aorta + arch replacement + elephant trunk stent , that is, artificial blood vessels are used to replace the ascending aorta and aortic arch, arch anastomosis or three-branch blood vessel anastomosis is performed in the aortic arch, and a covered stent is placed in the descending thoracic aorta (Frozen Elephant Trunk Technique).

Procedure: triple-branched stent graft

Interventions

triple-branched stent graft PROCEDURE

a triple-branched stent graft for aortic arch repairement during surgery

Aortic arch replacement with frozen elephant trunk; Triple-branched stent graft group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with acute type I aortic dissection who need arch repair;
• Aged ≥20 years and ≤65 years;
• Acute phase, with onset within 14 days before surgery;
• Subjects who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to accept follow-up.

You may not qualify if:

• The presence of anatomical variations, such as aortic arch malformation, aortic coarctation; common origin of the innominate artery and the left common carotid artery, aberrant right subclavian artery, abnormal origin of the left conical artery, stenosis or distortion of the branch arteries; and the diameter of the aortic arch and branch artery diameters do not match the specifications of the test device;
• Dissection is secondary to a history of aortic treatment, Marfan syndrome, etc.
• Aortic lesions and branch artery lesions caused by acute type I aortic dissection, including aortic pre-rupture, branch artery rupture, branch artery occlusion, and severe ischemic complications caused by poor organ perfusion, such as myocardial ischemia, stroke (ischemic brain injury), paraplegia (spinal artery ischemia), mesenteric artery ischemia, renal artery dysplasia, etc.
• Severe infectious lesions that are not controlled;
• Patients who need to receive other concomitant treatments, such as severe hypertension, chronic obstructive pulmonary disease, coronary heart disease, chronic kidney disease and other serious underlying lesions that require long-term treatment;
• Patients with other life-threatening lesions, such as advanced malignant tumors, and whose expected survival time is less than one year;
• Patients with other lesions in the heart and aorta (patients with other heart diseases that require concurrent heart surgery, such as coronary heart disease, mitral valve disease, tricuspid valve disease, etc.), who are not suitable for stent interventional treatment, such as peripheral vascular disease and blood disease;
• Subjects who have participated in other drug or device clinical trials and have not reached the primary study endpoint; and pregnant women.

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Department of Cardiovascular Surgery

Fuzhou, Fujian, 350001, China

RECRUITING

Study Officials

• Liang-wan Chen, M.D Ph.D

  Fujian Medical University Union Hospital

  STUDY CHAIR

Central Study Contacts

Liang-wan Chen, M.D Ph.D

CONTACT

+8613358255333; chenliangwan@tom.com

Xiao-fu Dai, M.D Ph.D

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: July 9, 2024
• Study Start: October 27, 2023
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2025
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)