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 range18 Years – 85 Years
SexALL
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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；
✕. Patients with a history of myocardial infraction or acute coronary syndromes in 3 months；
✕
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 cerebrovascular events or gastrointestinal bleeding in 3 months, antiplatelet agent and anticoagulant contraindication, or tendency of hemorrhageï¼›
✕. 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；