Thoracoabdominal Aortic Stent System for Endovascular Treatment of Thoracoabdominal Aortic Dissecting Aneurysm.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorLifetech Scientific (Shenzhen) Co., Ltd.

About this trial

A First in man study to evaluate the safety and efficacy of thoracoabdominal aortic stent system for endovascular treatment of thoracoabdominal aortic dissecting aneurysm.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged greater than 18 years old and less than 80 years old;

Anatomic criteria

Patients who understand the purpose of the trial, volunteer to participate and sign the informed consent form, and are willing to complete follow-up as required by the protocol;

Disqualifiers

Patients with severe hematoma in aortic wall in proximal anchoring area of stent

Patients requiring simultaneous coverage and embolization of bilateral internal iliac arteries;

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 a transient ischemic attack (TIA) or ischemic/hemorrhagic stroke within 3 months;

Trial design

Design model

Single group

Treatments tested in this trial

  • Thoracoabdominal aortic stent system

    Device

    Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with thoracoabdominal aortic stent system.

Treatment groups

46 Participants
are divided into 1 treatment group
Group A: Intervention armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The Incidence of Major Adverse Events (MAE) Within 30 Days Postoperative

Major Adverse events (MAE) are defined as death related to thoracic and abdominal aortic dissecting aneurysms, stroke, permanent paraplegia, kidney failure, intestinal necrosis, myocardial infarction, respiratory failure, and liver failure.

Time frame
within 30 days postoperative

Secondary outcomes

Other outcomes

Sponsors and contacts

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