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

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

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

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.

Study Type

Observational [Patient Registry]

Primary Outcome

Absence of major adverse events

Secondary Outcome

 Occurence of major adverse events

Condition

Abdominal Aortic Aneurysms

Intervention

INCRAFT

Study Arms / Comparison Groups

 INCRAFT
Description:  Endovascular abdominal aortic aneurysm repair

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

0

Start Date

August 31, 2019

Completion Date

December 31, 2021

Primary Completion Date

August 31, 2020

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;

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Zhong Chen, Doctor, ,

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT03965364

Organization ID

P18-0004

Responsible Party

Sponsor

Study Sponsor

Cordis Corporation

Study Sponsor

Zhong Chen, Doctor, Principal Investigator, Beijing Anzhen Hospital

Verification Date

February 2021