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出境医 / 临床实验 / Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)

Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)

Study Description
Brief Summary:
The sudy purpose is to investigate efficacy and safety of percutaneous endovascular aortic aneurysm repair using INCRAFT stent graft for Korean patients with abdominal aortic aneurysm. This study is designed as an investigator-initiated, multi-center, single-arm, prospective registry study. A total of 100 patients who meet all inclusion criteria, but none of exclusion criteria will be enrolled after the implantation of INCRAFT stent graft. The primary efficacy outcome is technical success defined as successful deployment of the stent-graft with no type I/III endoleak, unintentional coverage of visceral aortic branches or internal iliac arteries at the end of the procedure, and with successful removal of the delivery system. The primary safety outcome is major vascular complications at 30 days including. The study subjects will be followed for 12 months.

Condition or disease
Abdominal Aortic Aneurysm

Detailed Description:
Prospective single-arm multicenter registry
Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Technical success [ Time Frame: At the end of the procedure ]
    Technical success defined as successful deployment of the stent-graft with no type I/III endoleak, unintentional coverage of visceral aortic branches or internal iliac arteries at the end of the procedure, and with successful removal of the delivery system. Primary conversion or additional implantation of bare metal stent, aortic cuff or EndoAnchors to treat type I endoleak is considered a technical failure.


Secondary Outcome Measures :
  1. Major adverse event [ Time Frame: 30 days ]
    Major adverse event, a composite of death, myocardial infarction, stroke, or renal failure requiring dialysis) at 30 days

  2. Major adverse event [ Time Frame: 1 year ]
    Major adverse event, a composite of death, myocardial infarction, stroke, or renal failure requiring dialysis) at 1 year

  3. Aneurysm-related death [ Time Frame: 30 days ]
    All-cause death at 30 days

  4. Aneurysm-related death [ Time Frame: 1 year ]
    All-cause death at 1 year

  5. Aneurysm-related death [ Time Frame: 30 days ]
    Aneurysm-related death at 30 days

  6. Aneurysm-related death [ Time Frame: 1 year ]
    Aneurysm-related death at 1 year

  7. Reintervention [ Time Frame: 1 year ]
    Reintervention at 1 year

  8. Type I/III endoleaks [ Time Frame: 30 days ]
    Type I/III endoleaks at 30 days

  9. Type I/III endoleaks [ Time Frame: 1 year ]
    Type I/III endoleaks at 1 year

  10. Aneurysm-related event [ Time Frame: 1 year ]
    Aneurysm-related event (aneurysm-related death, reintervention, and aorta expansion> 5 mm, device migration, conversion to open repair, stent graft fracture, stent graft occlusion) at 1 year

  11. All vascular complications related to the INCRAFT device or aneurysm requiring surgical or endovascular interventions [ Time Frame: 30 days ]
    All vascular complications at 30 days related to the INCRAFT device or aneurysm requiring surgical or endovascular interventions

  12. Number of closure devices used for the closure of access sites. [ Time Frame: 30 days ]
    Number of closure devices used for the closure of access sites.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with abdominal aortic aneurysm treated with INCRAFT stent graft
Criteria

Inclusion Criteria:

  • 1. AAA with one of following indications

    1. AAA with maximum diameter > 5 cm,
    2. AAA with maximum diameter > 4 cm with an increase >0.5 cm during the preceding 6 months
    3. Saccular type AAA irrespective of the sac diameter.
  • 2. Proximal aortic neck length ≥10 mm with a diameter ≥ 17 and ≤ 31 mm in combination with supra- and infrarenal angulation ≤ 60 degree.
  • 3. Iliac landing zone with a length ≥15 mm and a diameter ≥ 7 and ≤ 22 mm
  • 4. Femoral access vessels should be adequate to fit the selected delivery system
  • 5. Minimum overall AAA treatment length (proximal landing location to distal landing location to distal landing location) ≥128 mm
  • 6. Aortic bifurcation >18 mm in diameter
  • 7. Patents with age of 19-80 years.
  • 8. Male or non-pregnant female
  • 9. Voluntary participation in the study with signed informed consent form.

Exclusion Criteria:

  • 1. Dissecting or ruptured abdominal aortic aneurysm
  • 2. Presence of connective tissue disease (Marfan's syndrome or Ehlers-Danlos syndrome).
  • 3. Prior AAA or iliac artery repair
  • 4. Active infection or active vasculitis.
  • 5. Myocardial infarction or cerebrovascular accident within 3 months prior to study enrolment.
  • 6. Need for renal artery coverage (e.g. Chimney graft)
  • 7. Dialysis-dependent renal failure or serum creatinine >2.0 mg/dl
  • 8. Intolerance/hypersensitivity to contrast media or antiplatelet drugs.
  • 9. Positive pregnancy test.
  • 10. Participation in another medical research study within 1 month of study enrolment.
  • 11. Planned concomitant surgical procedures (other than left subclavian artery transposition or bypass) or major surgery within 30 days of study enrolment.
  • 12. Patients with life expectancy less than 1 year
Contacts and Locations

Locations
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Korea, Republic of
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, 50 Yonsei-ro, Seodaemun-gu
Seoul, Korea, Republic of
Contact: Donghoon Choi, MD, PhD.    82-2-2228-8460    cdhlyj@yuhs.ac   
Sponsors and Collaborators
Yonsei University
Tracking Information
First Submitted Date May 14, 2019
First Posted Date May 16, 2019
Last Update Posted Date May 17, 2019
Estimated Study Start Date June 2019
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 14, 2019) 		Technical success [ Time Frame: At the end of the procedure ]
Technical success defined as successful deployment of the stent-graft with no type I/III endoleak, unintentional coverage of visceral aortic branches or internal iliac arteries at the end of the procedure, and with successful removal of the delivery system. Primary conversion or additional implantation of bare metal stent, aortic cuff or EndoAnchors to treat type I endoleak is considered a technical failure.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 14, 2019)
  • Major adverse event [ Time Frame: 30 days ]
    Major adverse event, a composite of death, myocardial infarction, stroke, or renal failure requiring dialysis) at 30 days
  • Major adverse event [ Time Frame: 1 year ]
    Major adverse event, a composite of death, myocardial infarction, stroke, or renal failure requiring dialysis) at 1 year
  • Aneurysm-related death [ Time Frame: 30 days ]
    All-cause death at 30 days
  • Aneurysm-related death [ Time Frame: 1 year ]
    All-cause death at 1 year
  • Aneurysm-related death [ Time Frame: 30 days ]
    Aneurysm-related death at 30 days
  • Aneurysm-related death [ Time Frame: 1 year ]
    Aneurysm-related death at 1 year
  • Reintervention [ Time Frame: 1 year ]
    Reintervention at 1 year
  • Type I/III endoleaks [ Time Frame: 30 days ]
    Type I/III endoleaks at 30 days
  • Type I/III endoleaks [ Time Frame: 1 year ]
    Type I/III endoleaks at 1 year
  • Aneurysm-related event [ Time Frame: 1 year ]
    Aneurysm-related event (aneurysm-related death, reintervention, and aorta expansion> 5 mm, device migration, conversion to open repair, stent graft fracture, stent graft occlusion) at 1 year
  • All vascular complications related to the INCRAFT device or aneurysm requiring surgical or endovascular interventions [ Time Frame: 30 days ]
    All vascular complications at 30 days related to the INCRAFT device or aneurysm requiring surgical or endovascular interventions
  • Number of closure devices used for the closure of access sites. [ Time Frame: 30 days ]
    Number of closure devices used for the closure of access sites.
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 Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)
Official Title Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)
Brief Summary The sudy purpose is to investigate efficacy and safety of percutaneous endovascular aortic aneurysm repair using INCRAFT stent graft for Korean patients with abdominal aortic aneurysm. This study is designed as an investigator-initiated, multi-center, single-arm, prospective registry study. A total of 100 patients who meet all inclusion criteria, but none of exclusion criteria will be enrolled after the implantation of INCRAFT stent graft. The primary efficacy outcome is technical success defined as successful deployment of the stent-graft with no type I/III endoleak, unintentional coverage of visceral aortic branches or internal iliac arteries at the end of the procedure, and with successful removal of the delivery system. The primary safety outcome is major vascular complications at 30 days including. The study subjects will be followed for 12 months.
Detailed Description Prospective single-arm multicenter registry
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with abdominal aortic aneurysm treated with INCRAFT stent graft
Condition Abdominal Aortic Aneurysm
Intervention Not Provided
Study Groups/Cohorts Not Provided
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 Not yet recruiting
Estimated Enrollment
 (submitted: May 14, 2019) 		100
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 1. AAA with one of following indications

    1. AAA with maximum diameter > 5 cm,
    2. AAA with maximum diameter > 4 cm with an increase >0.5 cm during the preceding 6 months
    3. Saccular type AAA irrespective of the sac diameter.
  • 2. Proximal aortic neck length ≥10 mm with a diameter ≥ 17 and ≤ 31 mm in combination with supra- and infrarenal angulation ≤ 60 degree.
  • 3. Iliac landing zone with a length ≥15 mm and a diameter ≥ 7 and ≤ 22 mm
  • 4. Femoral access vessels should be adequate to fit the selected delivery system
  • 5. Minimum overall AAA treatment length (proximal landing location to distal landing location to distal landing location) ≥128 mm
  • 6. Aortic bifurcation >18 mm in diameter
  • 7. Patents with age of 19-80 years.
  • 8. Male or non-pregnant female
  • 9. Voluntary participation in the study with signed informed consent form.

Exclusion Criteria:

  • 1. Dissecting or ruptured abdominal aortic aneurysm
  • 2. Presence of connective tissue disease (Marfan's syndrome or Ehlers-Danlos syndrome).
  • 3. Prior AAA or iliac artery repair
  • 4. Active infection or active vasculitis.
  • 5. Myocardial infarction or cerebrovascular accident within 3 months prior to study enrolment.
  • 6. Need for renal artery coverage (e.g. Chimney graft)
  • 7. Dialysis-dependent renal failure or serum creatinine >2.0 mg/dl
  • 8. Intolerance/hypersensitivity to contrast media or antiplatelet drugs.
  • 9. Positive pregnancy test.
  • 10. Participation in another medical research study within 1 month of study enrolment.
  • 11. Planned concomitant surgical procedures (other than left subclavian artery transposition or bypass) or major surgery within 30 days of study enrolment.
  • 12. Patients with life expectancy less than 1 year
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03952780
Other Study ID Numbers 1-2018-0081
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: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Yonsei University
Study Sponsor Yonsei University
Collaborators Not Provided
Investigators Not Provided
PRS Account Yonsei University
Verification Date May 2019

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