RecruitingNot ApplicableNCT05054985

Safety and Efficacy of a Multi-branched Thoracoabdominal Stent Graft System for Thoracoabdominal Aortic Aneurysm.

Guo's Renovisceral Artery Reconstruction-1: a Prospective, Multicenter, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of a Multi-branched Stent Graft System for Thoracoabdominal Aortic Aneurysm (GUARANTEE Study)


Sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Enrollment

73 participants

Start Date

Nov 12, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Evaluation of the safety and efficacy of a multi-branched thoracoabdominal stent graft system for thoracoabdominal aortic aneurysm.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new multi-branched stent graft system for treating thoracoabdominal aortic aneurysms (TAAAs) — dangerous bulges in the large artery running through the chest and abdomen. If left untreated, these aneurysms can rupture. This device is inserted through blood vessels (endovascular approach) rather than through open surgery, potentially making treatment less invasive. You may be eligible if: - You are between 18 and 80 years old - You have been diagnosed with a thoracoabdominal aortic aneurysm meeting size or growth criteria - Your anatomy (artery diameters and lengths) meets the device requirements - You are able to provide informed consent and willing to complete follow-up visits You may NOT be eligible if: - Your aneurysm has already ruptured and you are hemodynamically unstable - You have aortic dissection (a tear in the wall of the aorta), fungal/infectious aneurysm, or connective tissue disease (e.g., Marfan syndrome, Behcet's disease) - You have had a heart attack (acute coronary syndrome) within 6 months or a stroke/TIA within 3 months - You have severe liver, kidney, or lung problems - You have severe blood clotting problems - You are pregnant, planning pregnancy, or breastfeeding - You have had major surgery within the last 30 days - You have allergies to contrast dye, stents, anticoagulants, or related materials Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEMulti-Branched Thoracoabdominal Stent Graft System

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


Locations(1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05054985


Related Trials