Concave Supra-arch Branched Stent-Graft System for Treatment of Aortic Arch Diseases

NCT05996354 | Unknown

• 1 other identifier: XJ-PR48-FIM-05
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

Brief Summary

There are no endoluminal stent systems available on the Chinese market for the effective treatment of aortic arch lesions (involving aortic arch aneurysms, aortic coarctation, aortic pseudoaneurysms, aortic ulcers, and intermural hematomas), and therefore this study is intended to be a prospective, single-arm study.

Conditions

Aortic Dissection; Aneurysm, Aortic Arch; Aortic Pseudoaneurysm; Aortic Ulcer, Penetrating; Aortic Intramural Hematoma

Outcome Measures

Primary Outcomes (1)

• Immediate technical success rate

  Immediate technical success refers to the successful delivery system to a predetermined location, the successful deployment of the system and the safe withdrawal of the delivery system from the body, and the branch arteries were successfully reconstructed.

  Immediate intraoperative

Study Arms (1)

Intervention arm

EXPERIMENTAL

Concave Supra-arch Branched stent-graft system

Device: Concave Supra-arch Branched stent-graft system

Interventions

Concave Supra-arch Branched stent-graft system DEVICE

To evaluate the efficacy and safety of the Concave Supra-arch Branched stent-graft system for endovascular treatment of aortic arch diseases.

Intervention arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are ≥ 18 years old and ≤ 85 years old；
• Patients with aortic arch diseases (involving aortic arch aneurysm, aortic dissection, aortic pseudoaneurysm, aortic ulcer, and intermural hematoma);
• Anatomical criteria, including:
• Ascending aorta length is greater than or equal to 50 mm (distance from aortic sinus to anterior edge of innominate artery);
• The diameter range of the anchoring area at the proximal end of the main body is between 25-45 mm and the length is greater than or equal to 15 mm;
• The diameter of the anchored area of the innominate artery is between 10-16 mm, the diameter of the anchored area of the left common carotid artery is between 5-12 mm, and the diameter of the anchored area of the left subclavian artery is between 5-12 mm. Anchorage zone length is greater than or equal to 15 mm;
• Distance between the anterior edge of the innominate artery to the posterior edge of the left subclavian artery is less than or equal to 80 mm;
• Have a suitable iliac, femoral, and superior arch arterial approach;
• Patients who understand the purpose of the study, volunteer to participate and sign the informed consent form, and are willing to complete follow-up visits as required by the protocol.

You may not qualify if:

• Patients with general or local infections that may increase the risk of endovascular graft infection;
• Patients with severe stenosis, calcification, or mural thrombus in the stent anchoring area, which is likely to make the stent-graft difficult to adhere to or affect the patency of the stent;
• Patients with neck vascular surgery within 3 months;
• Patients with severe carotid or subclavian artery stenosis, calcification;
• Patients with a history of acute coronary syndrome within 6 months:
• Acute coronary syndromes are cardiac acute ischemic syndromes resulting from rupture of an unstable atherosclerotic plaque in the coronary artery or erosion secondary to the formation of new blood 4 thrombus, including ST-elevation myocardial infarction, non-ST elevation myocardial infarction, and unstable angina.
• Patients with transient ischemic attack (TIA) or ischemic stroke within 3 months;
• Patients with preoperative hepatic and renal dysfunction, \[alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeded the upper limit of normal level by a factor of five; Serum creatinine (Cr) \>150umol/L\];
• Patients with history of bleeding or coagulopathy, who cannot receive antiplatelet therapy;
• Patients with severe aortic insufficiency or a history of prior aortic valve insufficiency treatment;
• Patients with a history of hypersensitivity to contrast agents, anticoagulant antiplatelet agents, stents, delivery equipment materials (i.e., nitinol, polyester, PTFE, nylon polymer materials);
• Patients with connective tissue diseases such as Marfan's syndrome, Egyptian syndrome, or Behcet's disease;
• Patients with arteritis;
• Patients with significant organ dysfunction or other serious disease;
• Patients with life expectancy of not more than 1 year;

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (3)

Chinese Academy of Medical Sciences Fuwai Hospital

Beijing, Beijing Municipality, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Yunnan Fuwai cardiovascular disease Hospital

YunNan, Yunnan, China

Location

MeSH Terms

Conditions

Aortic Dissection; Aneurysm, Aortic Arch; Penetrating Atherosclerotic Ulcer; Aortic Intramural Hematoma

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases; Aortic Aneurysm, Thoracic; Aortic Aneurysm; Arteriosclerosis; Arterial Occlusive Diseases; Hematoma; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 18, 2023
• Study Start: March 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: April 30, 2025
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)