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NCT Number: NCT04918212

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

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.

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Key information

Conditions

Aortic Dissection Type B

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Friendship Hospital, Capital Medical University, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Fabulous Stent Graft System

Device

All patients received endovascular surgery using fabulous stent graft system

Primary outcomes

  1. Number of patients with no incidence of major surgical or device related adverse events rate

    Time frame: 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

    Time frame: 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 outcomes

  1. adverse event rate

    Time frame: within 12 months after surgery

  2. Immediate delivery success rate

    Time frame: immediately after the surgery

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

  3. Immediate operation successful rate

    Time frame: 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

    Time frame: within 12 months after surgery

  5. Secondary surgical treatment rate

    Time frame: within 12 months after surgery

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

Sponsors and collaborators

Lead sponsor

Hangzhou Endonom Medtech Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 8, 2021
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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