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

C

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Withdrawn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:

  • Aneurysm sac rupture or leaking abdominal aortic aneurysm
  • 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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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