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

A Multicenter, Open Label, Prospective, Post-Market Study of the INCRAFT AAA Stent Graft in Subjects With Abdominal Aortic Aneurysms

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.

Study Overview

• Status: Withdrawn
• Conditions: Abdominal Aortic Aneurysms
• Intervention / Treatment: Device: INCRAFT

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

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Anzhen Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who are eligible for endovascular repair of an abdominal aortic aneurysm

Description

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;

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
INCRAFT; Endovascular abdominal aortic aneurysm repair	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence of major adverse events	MAE is defined as the combination of death, myocardial infarction, stroke/cerebrovascular accident, and renal failure.	Within 30-days post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurence of major adverse events	MAE is defined as the combination of death, myocardial infarction, stroke/cerebrovascular accident, and renal failure.	Through 1 year post-procedure
Technical success	The technical success at the end of the first surgery, which was defined as the successful insertion of the delivery system and the successful placement of the device at the desired location.	At the conclusion of the index procedure
Absence of stent graft migration(>10mm)	Stent graft migration is defined as evidence of proximal or distal movement of the stent graft > 10mm relative to fixed anatomical landmarks compared with the 1 month size measurement.	Assessed at 1 year
Absence of Type I or Type III endoleak and no aneurysm enlargement (growth >5mm)	Endoleak is defined as a persistent blood flow outside the lumen of the endoluminal graft but within an aneurysm sac or adjacent vascular segment being treated by the device. They are the result of incomplete sealing, or exclusion of the aneurysm sac, and thus cause reflux of blood flow into the sac. Aneurysm enlargement is defined as an increase in maximum aneurysm cross sectional diameter greater than 5mm compared to a baseline measurement, or any subsequent measurement following baseline.	Assessed at 1 year compared to size measurement at 1 month
Absence of stent graft fracture	Stent-graft fracture is defined as stent skeleton fracture and barb separation.	Assessed within 30-days and 1-year post-procedure
Absence of stent occlusion (including unilateral or bilateral limb occlusion) and aneurysm sac rupture	Stent occlusion is defined as a complete absence of flow, within the AAA stent graft (aortic bifurcate or one or both iliac limbs).	Within 1-year post-procedure
Absence of all-cause mortality and aneurysms-related death	Aneurysms-related death is defined as a death from AAA rupture, or death within 30 days of open aortic surgical or endovascular repair or death from any subsequent procedure required to treat the same aneurysm.	Within 1-year post-procedure

Collaborators and Investigators

• Sponsor: Cordis Corporation
• Investigators: Principal Investigator: Zhong Chen, Doctor, Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 31, 2019
• Primary Completion (Anticipated): August 31, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: May 15, 2019
• First Submitted That Met QC Criteria: May 24, 2019
• First Posted (Actual): May 29, 2019

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: P18-0004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes