China Post-market Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INITIATION)
A Multicenter, Open Label, Prospective, Post-Market Study of the INCRAFT AAA Stent Graft in Subjects With Abdominal Aortic Aneurysms
INITIATION is a postmarket clinical follow-up study in China. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of Incraft in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 120 subjects will be enrolled and followed through 1-years postprocedure. Up to 20 sites in China may participate.
INITIATION is a postmarket clinical follow-up study in China. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of Incraft in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 120 subjects will be enrolled and followed through 1-years postprocedure. Up to 20 sites in China may participate. Subjects will be enrolled and followed at 1 month and 1 year post-procedure.
Observational [Patient Registry]
Absence of major adverse events
Occurence of major adverse events
Abdominal Aortic Aneurysms
Study Arms / Comparison Groups
Description: Endovascular abdominal aortic aneurysm repair
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
August 31, 2019
December 31, 2021
Primary Completion Date
August 31, 2020
Inclusion Criteria: - Male or female aged 18 and over - The femoral access vessel is adequate for the selected delivery system; - Length of proximal aneurysmal neck ≥ 10mm; - Aortic neck diameter ≥ 17mm and ≤ 31mm; - The aortic neck is suitable for suprarenal fixation; - The angle of the infrarenal and suprarenal neck is ≤60 degrees; - Iliac fixation length ≥ 15mm; - Iliac diameter ≥ 7mm and ≤ 22mm; - Minimum total AAA treatment length (proximal landing point to distal landing point) ≥ 128mm; - Morphology is suitable for aneurysm repair; - Written informed consent form shall be provided prior to initiating any study protocol; - The subject is willing to follow the prescribed follow-up schedule. Exclusion Criteria: - The subject has one of the following conditions: 1. Aneurysm sac rupture or leaking abdominal aortic aneurysm 2. Mycotic, dissecting, or inflammatory abdominal aortic aneurysm; - Known to be allergic or intolerant to nickel titanium (Nitinol), polyethylene terephthalate (PET) or polytetrafluoroethylene (PTFE); - Known contraindication to undergoing angiography or anticoagulation - Existing AAA surgical graft and/or a AAA stent-graft system; - Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial;
18 Years - N/A
Accepts Healthy Volunteers
Zhong Chen, Doctor, ,
Zhong Chen, Doctor, Principal Investigator, Beijing Anzhen Hospital