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

Withdrawn

• Conditions: Abdominal Aortic Aneurysms
• Interventions: Device: INCRAFT

• Registration Number: NCT03965364
• Lead Sponsor: Cordis Corporation

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 Timeline

• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-05-24
• Study First Posted: 2019-05-29
• Study Start: 2019-08-31
• Primary Completion: 2020-08-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-02-26
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
INCRAFT	INCRAFT	Endovascular abdominal aortic aneurysm repair

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Occurence of major adverse events	Through 1 year post-procedure	MAE is defined as the combination of death, myocardial infarction, stroke/cerebrovascular accident, and renal failure.
Technical success	At the conclusion of the index procedure	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.
Absence of stent graft migration(>10mm)	Assessed at 1 year	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.
Absence of Type I or Type III endoleak and no aneurysm enlargement (growth >5mm)	Assessed at 1 year compared to size measurement at 1 month	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.
Absence of stent graft fracture	Assessed within 30-days and 1-year post-procedure	Stent-graft fracture is defined as stent skeleton fracture and barb separation.
Absence of stent occlusion (including unilateral or bilateral limb occlusion) and aneurysm sac rupture	Within 1-year post-procedure	Stent occlusion is defined as a complete absence of flow, within the AAA stent graft (aortic bifurcate or one or both iliac limbs).
Absence of all-cause mortality and aneurysms-related death	Within 1-year post-procedure	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.

Trial Locations

Locations (1)

Beijing Anzhen Hospital; 🇨🇳 Beijing, China