Safety and Efficacy Study of Fabulous Stent Graft System for Stanford B Aortic Dissection

Safety and Efficacy Study of Fabulous Stent Graft System for Stanford B Aortic Dissection: A Prospective, Multi-center, Single Arm, Objective Performance Criteria Clinical Trial

A prospective, multi-center, objective performance criteria clinical trial to evaluate the safety and efficacy of Fabulous Stent Graft System manufactured by Hangzhou Endonom Medtech Co., Ltd. for Stanford B Aortic Dissection.

Study Overview

• Status: Completed
• Conditions: Aortic Dissection Type B
• Intervention / Treatment: Device: Fabulous Stent Graft System

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Friendship Hospital, Capital Medical University
  • Beijing, China
    • Peking University People's Hospital
  • Beijing, China
    • Chinese People's Liberation Army General Hospital
  • Changsha, China
    • Xiangya Hospital of Central South University
  • Chengdu, China
    • West China Hospital of Sichuan University
  • Fuzhou, China
    • The First Affiliated Hospital of Fujian Medical University
  • Guangzhou, China
    • Guangdong Provincial People's Hospital
  • Haikou, China
    • Hainan Provincial People's Hospital
  • Hangzhou, China
    • Second Affiliated Hospital of Zhejiang University School of Medicine
  • Hangzhou, China
    • The First Affiliated Hospital of Zhejiang University School of Medicine
  • Hefei, China
    • Anhui Provincial Hospital
  • Kunming, China
    • The First Affiliated Hospital of Kunming Medical College
  • Liuzhou, China
    • Liuzhou Workers' Hospital
  • Nanchang, China
    • The Second Affiliated Hospital of Nanchang University
  • Nanjing, China
    • Jiangsu Provincial People's Hospital
  • Nanning, China
    • The First Affiliated Hospital of Guangxi Medical University
  • Shanghai, China
    • Zhongshan Hospital Affiliated to Fudan University
  • Shanghai, China
    • The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
  • Shijia Zhuang, China
    • The First Hospital of Hebei Medical University
  • Tianjin, China
    • Tianjin Medical University General Hospital
  • Xi'an, China
    • The First Affiliated Hospital of the Fourth Military Medical University
  • Yantai, China
    • Yantai Yuhuangding Hospital
  • Zhengzhou, China
    • Henan Provincial People's Hospital
  • Zhengzhou, China
    • First Affiliated Hospital of Zhengzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients ≥18 years old;
2. The informed consent was signed by the patient or the legal representative;
3. Diagnosed with Stanford B aortic dissection;
4. The proximal anchoring area of is 18-42 mm in diameter, and not less than 15mm in length;
5. Has a suitable arterial approach and is suitable for surgical treatment.

Exclusion Criteria:

1. The patient's distal vascular false cavity has been completely thrombotic or organized;
2. Pregnant or breastfeeding ;
3. Has participated in clinical trials of other devices ；
4. History of aortic surgery or endovascular repair surgery ;
5. Allergic to contrast agents and anesthetics ;
6. Allergic to stents or conveyors ;
7. Patients with true or false aortic aneurysm;
8. History of myocardial infarction, TIA or cerebral infarction within the past 3 months;
9. Life expectancy is less than 12 months;
10. Other situations in which the investigator judges that not suitable for endovascular treatment .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fabulous Stent Graft System; All patients received endovascular surgery using fabulous stent graft system	Device: Fabulous Stent Graft System; All patients received endovascular surgery using fabulous stent graft system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with no incidence of major surgical or device related adverse events rate	Surgical or device related major adverse events (MAE) : death, respiratory failure, renal failure, stroke, paraplegia, intestinal ischemia, cardiovascular and vascular complications caused by surgery or device	within 30 days after surgery
Clinical success rate	Clinical success is defined as : no displacement of Stent Graft System, no type I or III endoleak requiring treatment, no enlargement of the false lumen, thrombosis of the false lumen, and no rupture of the dissection	12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse event rate		within 12 months after surgery
Immediate delivery success rate	The stent graft system was successfully transported to the correct position and released successfully	immediately after the surgery
Immediate operation successful rate	After the operation, angiographic observation showed that the proximal covered stent was in an appropriate position and adhered well without obvious endoleak, while the distal bare stent was in an appropriate position and adhered well	immediately after the surgery
Endoleak rate		within 12 months after surgery
Secondary surgical treatment rate	Secondary endovascular or surgical treatment due to stent displacement, endoleak, or related complications after stent implantation	within 12 months after surgery

Collaborators and Investigators

• Sponsor: Hangzhou Endonom Medtech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2017
• Primary Completion (Actual): October 13, 2020
• Study Completion (Actual): October 13, 2020

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Actual): November 8, 2021
• Last Update Submitted That Met QC Criteria: November 1, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting
• Other Study ID Numbers: WQ1601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No