Prospective Study for Aortic Arch Therapy With stENt-graft for Chimney technologY（PATENCY） (NCT03767777) | Clinical Trial Compass
CompletedNot Applicable
Prospective Study for Aortic Arch Therapy With stENt-graft for Chimney technologY（PATENCY）
China150 participantsStarted 2019-02-01
Plain-language summary
A prospective, multi-centre, objective performance criteria clinical trial to evaluate the safety and efficacy of Artery Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for the thoracic aortic dissection involving the aortic arch.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients are 18 years and older, but less than 85 years old and not pregnant or lactating;
. Patients who can understand the purpose of the trial, voluntarily participate in and sign the informed consent, and are willing to complete the follow-up according to the requirements of the protocol;
. Patients diagnosed as thoracic aortic dissection involving the arch, and the left subclavian artery branching vessel needs to be revascularized;
. Aortic proximal landing zone ≥15mm；
. Aortic proximal diameter in the range of 25-44mm;
. The left subclavian artery distal landing zone≥15mm;
. The left subclavian artery diameter in the range of 5-18mm；
. Patients who have eligible imported arterial vessels.
Exclusion criteria
. Patients with severe stenosis, calcification in the landing area of the stent and easily lead to incomplete stent apposition;
. Patients need intervention for other vascular diseases (such as coronary artery /renal artery) in the same surgery, or patients with heart disease and medicine treatment will be affected by the intervention；
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The treatment success rate of aortic dissection at 12 months post-implant
Timeframe: 12 months after surgery
2
Incidence of no major adverse events (MAE) occurred at 30 days post-implant
. Patients with a history of myocardial infraction or acute coronary syndromes in 3 months；
. Patients with a history of cerebrovascular events or gastrointestinal bleeding in 3 months, antiplatelet agent and anticoagulant contraindication, or tendency of hemorrhage；
. Patients have received any major surgical or interventional therapy within 30 days (Operation Classification reaches III or above) or have received interventional therapy;
. Patients will receive any major selective operation or interventional therapy in 30days (Operation Classification reaches III or above) or will received interventional therapy;
. Patients already treated with an thoracic aortic stent graft and the stent graft can affect operation or intersection part existing between the graft covering area；
. Patients with genetic connective tissue disease (e.g., Marfans syndrome) or aorta hereditary disease；