Phase
Condition
Vascular Diseases
Chest Pain
Aneurysm
Treatment
PerMed Stent Graft System In Surgical Operation
Endovastec CRONUS® Intraoperative stent system
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥ 18 and ≤ 75 years, male or female;
- Stanford type A aortic dissection subjects with involvement of the descending archaorta;
- Subjects treated with stent pictorial procedures as judged appropriate by theinvestigator;
- Subjects or their legal surrogates were able to understand the purpose of the study,had adequate compliance to the clinical study protocol, and voluntarily signed theinformed consent form.
Exclusion
Exclusion Criteria:
- Subjects with aortic dissections confined to the ascending and / or arch
- Subjects with a left common carotid artery branch vessel diameter < 5 mm or > 16 mm (not applicable to subjects enrolled with a single branch structure)
- Subjects with a left subclavian artery branch vessel diameter < 7 mm or > 16 mm
- Subjects with aortic dissection with severe malperfusion syndrome preoperatively (e.g., subjects presenting with coma, paraplegia, need for dialysis, gastrointestinalnecrosis or limb necrosis due to ischemia, etc.)
- Subjects with vertebral artery variants
- Subjects with infectious aortic dissections
- Subjects with acute systemic infection, severe infection and associated sepsis, shockor multiple organ failure
- Subjects unable to tolerate anaesthesia and cardiopulmonary bypass
- Subjects who had undergone open surgical procedures of the cardiocerebral vasculaturewithin 90 days prior to surgery
- Subjects with history of active bleeding, coagulopathy or refusal of blood transfusion
- Subjects known to be allergic to materials such as contrast agents, nitinol alloys,coated artificial blood vessels
- Subjects with a life expectancy of less than 12 months (other than disease due toaortic dissection)
- Subjects being enrolled in other clinical trials
- Pregnant and lactating women, and subjects with a recent pregnancy preparation
- Subjects with poor compliance other conditions that the investigator considersinappropriate for participation in the clinical trial.
Study Design
Study Description
Connect with a study center
Anhui Provincial Hospital
Hefei, Anhui 230002
ChinaSite Not Available
First Hospital Affiliated to the Army Medical University
Chongqing, Chongqing 400037
ChinaSite Not Available
Fujian Medical University Union Hospital
Fuzhou, Fujian 350001
ChinaSite Not Available
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei 050030
ChinaSite Not Available
First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang 150020
ChinaSite Not Available
Wuhan Union Hospital, China
Wuhan, Hubei 430022
ChinaSite Not Available
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu 210000
ChinaSite Not Available
Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi 330038
ChinaSite Not Available
The First Hospital of Jilin University
Changchun, Jilin 130061
ChinaSite Not Available
First Affiliated Hospital Xi'an Jiaotong University
Xi'an, Shaanxi 710061
ChinaSite Not Available
Linyi People's Hospital
Linyi, Shandong 276034
ChinaSite Not Available
Changhai Hospital
Shanghai, Shanghai 200433
ChinaSite Not Available
Shanghai Zhongshan Hospital
Shanghai, Shanghai 200032
ChinaSite Not Available
The University of Hong Kong-Shenzhen Hospital
Shenzhen, Shenzhen 518048
ChinaSite Not Available
West China Hospital
Chendu, Sichuan 610041
ChinaSite Not Available
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang 830011
ChinaSite Not Available
Yan 'an Hospital Affiliated to Kunming Medical University
Kunming, Yunnan 650031
ChinaSite Not Available
Permed Biomedical Engineering Co., Ltd
Beijing, 102600
ChinaSite Not Available
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