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

NCT03965364 | Withdrawn FDA Device

• 1 other identifier: P18-0004
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Occurence of major adverse events

  Through 1 year post-procedure

• Technical success

  At the conclusion of the index procedure

• Absence of stent graft migration(>10mm)

  Assessed at 1 year

• 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

• Absence of stent graft fracture

  Assessed within 30-days and 1-year post-procedure

Study Arms (1)

INCRAFT

Endovascular abdominal aortic aneurysm repair

Device: INCRAFT

Interventions

INCRAFT 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.

INCRAFT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (1)

Beijing Anzhen Hospital

Beijing, China

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Zhong Chen, Doctor

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 29, 2019
• Study Start: August 31, 2019
• Primary Completion: August 31, 2020
• Study Completion: December 31, 2021
• Last Updated: February 26, 2021

Record last verified: 2021-02

Locations

CN (1)