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

Primary Purpose

Aortic Dissection, Aneurysm, Aortic Arch, Aortic Pseudoaneurysm

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Concave Supra-arch Branched stent-graft system
Sponsored by
China National Center for Cardiovascular Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Dissection

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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; Patients who are not eligible for endovascular treatment per in the investigator's judgment of the investigator; Women with planned pregnancy, pregnancy stage , or lactation The patient participated in another clinical trial and was not out or withdrawn within the first 3 months of the screening period of this study.

Sites / Locations

  • Chinese Academy of Medical Sciences Fuwai Hospital
  • The Second Xiangya Hospital of Central South University
  • Yunnan Fuwai cardiovascular disease Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention arm

Arm Description

Concave Supra-arch Branched stent-graft system

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 3, 2023
Last Updated
October 8, 2023
Sponsor
China National Center for Cardiovascular Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT05996354
Brief Title
Concave Supra-arch Branched Stent-Graft System for Treatment of Aortic Arch Diseases
Official Title
A Study on the Concave Supra-arch Branched Stent-Graft System for Treatment of Aortic Arch Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China National Center for Cardiovascular Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
The physician shall strictly follow the clinical study protocol and shall not deviate from or substantially change the protocol. However, in case of emergency such as immediate risk to the subjects, which needs to be eliminated immediately, it may be reported in written form afterwards. During the course of the study, documents such as amendments to the clinical study protocol and informed consent, requests for deviation, and resumption of the suspended clinical study shall be subject to the written approval of the Ethics Committee.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Dissection, Aneurysm, Aortic Arch, Aortic Pseudoaneurysm, Aortic Ulcer, Penetrating, Aortic Intramural Hematoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Concave Supra-arch Branched stent-graft system
Intervention Type
Device
Intervention Name(s)
Concave Supra-arch Branched stent-graft system
Intervention Description
To evaluate the efficacy and safety of the Concave Supra-arch Branched stent-graft system for endovascular treatment of aortic arch diseases.
Primary Outcome Measure Information:
Title
Immediate technical success rate
Description
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.
Time Frame
Immediate intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; Patients who are not eligible for endovascular treatment per in the investigator's judgment of the investigator; Women with planned pregnancy, pregnancy stage , or lactation The patient participated in another clinical trial and was not out or withdrawn within the first 3 months of the screening period of this study.
Facility Information:
Facility Name
Chinese Academy of Medical Sciences Fuwai Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Yunnan Fuwai cardiovascular disease Hospital
City
YunNan
State/Province
Yunnan
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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