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

Sponsor
Hangzhou Endonom Medtech Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT04918212
Collaborator
(none)
148
Enrollment
24
Locations
1
Arm
34.6
Actual Duration (Months)
6.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Fabulous Stent Graft System
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
148 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Nov 25, 2017
Actual Primary Completion Date :
Oct 13, 2020
Actual Study Completion Date :
Oct 13, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Number of patients with no incidence of major surgical or device related adverse events rate [within 30 days after surgery]

    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

  2. Clinical success rate [12 months after surgery]

    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

Secondary Outcome Measures

  1. adverse event rate [within 12 months after surgery]

  2. Immediate delivery success rate [immediately after the surgery]

    The stent graft system was successfully transported to the correct position and released successfully

  3. Immediate operation successful rate [immediately after the surgery]

    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

  4. Endoleak rate [within 12 months after surgery]

  5. Secondary surgical treatment rate [within 12 months after surgery]

    Secondary endovascular or surgical treatment due to stent displacement, endoleak, or related complications after stent implantation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 .

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Friendship Hospital, Capital Medical University Beijing China
2 Chinese People's Liberation Army General Hospital Beijing China
3 Peking University People's Hospital Beijing China
4 Xiangya Hospital of Central South University Changsha China
5 West China Hospital of Sichuan University Chengdu China
6 The First Affiliated Hospital of Fujian Medical University Fuzhou China
7 Guangdong Provincial People's Hospital Guangzhou China
8 Hainan Provincial People's Hospital Haikou China
9 Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou China
10 The First Affiliated Hospital of Zhejiang University School of Medicine Hangzhou China
11 Anhui Provincial Hospital Hefei China
12 The First Affiliated Hospital of Kunming Medical College Kunming China
13 Liuzhou Workers' Hospital Liuzhou China
14 The Second Affiliated Hospital of Nanchang University Nanchang China
15 Jiangsu Provincial People's Hospital Nanjing China
16 The First Affiliated Hospital of Guangxi Medical University Nanning China
17 The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine Shanghai China
18 Zhongshan Hospital Affiliated to Fudan University Shanghai China
19 The First Hospital of Hebei Medical University Shijia Zhuang China
20 Tianjin Medical University General Hospital Tianjin China
21 The First Affiliated Hospital of the Fourth Military Medical University Xi'an China
22 Yantai Yuhuangding Hospital Yantai China
23 First Affiliated Hospital of Zhengzhou University Zhengzhou China
24 Henan Provincial People's Hospital Zhengzhou China

Sponsors and Collaborators

  • Hangzhou Endonom Medtech Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hangzhou Endonom Medtech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04918212
Other Study ID Numbers:
  • WQ1601
First Posted:
Jun 8, 2021
Last Update Posted:
Nov 8, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Aneurysm, Dissecting

Study Results

No Results Posted as of Nov 8, 2021