Clinical trial NCT03965364: China Post-market Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INITIATION)
Official title: A Multicenter, Open Label, Prospective, Post-Market Study of the INCRAFT AAA Stent Graft in Subjects With Abdominal Aortic Aneurysms
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Abdominal Aortic Aneurysms
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
First posted: 2019-05-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are eligible for endovascular repair of an abdominal aortic aneurysm

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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;

Primary outcomes:
measure: Absence of major adverse events
timeFrame: Within 30-days post-procedure
Secondary outcomes:
measure: Occurence of major adverse events
timeFrame: Through 1 year post-procedure
measure: Technical success
timeFrame: At the conclusion of the index procedure
measure: Absence of stent graft migration(>10mm)
timeFrame: Assessed at 1 year
measure: Absence of Type I or Type III endoleak and no aneurysm enlargement (growth >5mm)
timeFrame: Assessed at 1 year compared to size measurement at 1 month
measure: Absence of stent graft fracture
timeFrame: Assessed within 30-days and 1-year post-procedure
measure: Absence of stent occlusion (including unilateral or bilateral limb occlusion) and aneurysm sac rupture
timeFrame: Within 1-year post-procedure
measure: Absence of all-cause mortality and aneurysms-related death
timeFrame: Within 1-year post-procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
Study officials:
affiliation: Beijing Anzhen Hospital
name: Zhong Chen, Doctor
role: PRINCIPAL_INVESTIGATOR
References: