China Post-market Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INITIATION)

Cordis

Status: Withdrawn

Conditions: Abdominal Aortic Aneurysms

Treatments: Device: INCRAFT

Study type: Observational

Funder types: Industry

Identifiers

NCT03965364

P18-0004

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

0 participants in 1 patient group

INCRAFT

Description:

Endovascular abdominal aortic aneurysm repair

Treatment:

Device: INCRAFT