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出境医 / 临床实验 / China Post-market Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INITIATION)

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

Study Description
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.

Condition or disease Intervention/treatment
Abdominal Aortic Aneurysms 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 Design
Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: A Multicenter, Open Label, Prospective, Post-Market Study of the INCRAFT AAA Stent Graft in Subjects With Abdominal Aortic Aneurysms
Estimated Study Start Date : August 31, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : December 31, 2021
Arms 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.

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


Secondary Outcome Measures :
  1. Occurence of major adverse events [ Time Frame: Through 1 year post-procedure ]
    MAE is defined as the combination of death, myocardial infarction, stroke/cerebrovascular accident, and renal failure.

  2. Technical success [ Time Frame: 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.

  3. Absence of stent graft migration(>10mm) [ Time Frame: 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.

  4. Absence of Type I or Type III endoleak and no aneurysm enlargement (growth >5mm) [ Time Frame: 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.


  5. Absence of stent graft fracture [ Time Frame: Assessed within 30-days and 1-year post-procedure ]
    Stent-graft fracture is defined as stent skeleton fracture and barb separation.

  6. Absence of stent occlusion (including unilateral or bilateral limb occlusion) and aneurysm sac rupture [ Time Frame: 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).

  7. Absence of all-cause mortality and aneurysms-related death [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are eligible for endovascular repair of an abdominal aortic aneurysm
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;
Contacts and Locations

Locations
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China
Beijing Anzhen Hospital
Beijing, China
Sponsors and Collaborators
Cordis Corporation
Investigators
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Principal Investigator: Zhong Chen, Doctor Beijing Anzhen Hospital
Tracking Information
First Submitted Date May 15, 2019
First Posted Date May 29, 2019
Last Update Posted Date February 26, 2021
Estimated Study Start Date August 31, 2019
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 24, 2019)
Absence of major adverse events [ Time Frame: Within 30-days post-procedure ]
MAE is defined as the combination of death, myocardial infarction, stroke/cerebrovascular accident, and renal failure.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 24, 2019)
  • Occurence of major adverse events [ Time Frame: Through 1 year post-procedure ]
    MAE is defined as the combination of death, myocardial infarction, stroke/cerebrovascular accident, and renal failure.
  • Technical success [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who are eligible for endovascular repair of an abdominal aortic aneurysm
Condition Abdominal Aortic Aneurysms
Intervention 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.
Study Groups/Cohorts INCRAFT
Endovascular abdominal aortic aneurysm repair
Intervention: Device: INCRAFT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: February 24, 2021)
0
Original Estimated Enrollment
 (submitted: May 24, 2019)
120
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
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;
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03965364
Other Study ID Numbers P18-0004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Cordis Corporation
Study Sponsor Cordis Corporation
Collaborators Not Provided
Investigators
Principal Investigator: Zhong Chen, Doctor Beijing Anzhen Hospital
PRS Account Cordis Corporation
Verification Date February 2021