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

NCT ID: NCT03965364

Last Updated: 2021-02-26

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-31
• Study Completion Date: 2021-12-31

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.

Conditions

Abdominal Aortic Aneurysms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

INCRAFT

Endovascular abdominal aortic aneurysm repair

INCRAFT

Intervention Type: DEVICE

Device: Endovascular abdominal aortic aneurysm repair Subjects with infrarenal abdominal aortic aneurysms who meet all inclusion criteria and none of the exclusion criteria will be treated with the INCRAFT Stent Graft System.

Interventions

INCRAFT

Device: Endovascular abdominal aortic aneurysm repair Subjects with infrarenal abdominal aortic aneurysms who meet all inclusion criteria and none of the exclusion criteria will be treated with the INCRAFT Stent Graft System.

Intervention Type: DEVICE

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cordis Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhong Chen, Doctor

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Locations

Beijing Anzhen Hospital

Beijing, , China

Countries

China

Other Identifiers

P18-0004

Identifier Type: -

Identifier Source: org_study_id