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A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With AAA (INNOVATION) (INNOVATION)

Primary Purpose

Abdominal Aortic Aneurysms

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cordis AAA stent graft system "INCRAFT TM"
Sponsored by
Cordis Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysms focused on measuring Abdominal aortic aneurysm, AAA, Safety, Performance, Stent graft system, First in Human, Endovascular repair

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA:

  1. Subject is a male or infertile female > 18 years of age
  2. Subject understands study requirements and treatment procedures and agrees to sign an informed consent form prior to any study procedures.
  3. Subject is considered an appropriate candidate for open surgical repair of an abdominal aortic aneurysm.

  4. Subject has at least one of the following:

    1. Abdominal aortic aneurysm ≥4.5 cm in women or ≥ 5 cm in men in diameter
    2. Aneurysm, which is >4 cm and which has increased in size by 0.5 cm within 6 months
    3. The maximum aortic diameter is ≥1.5 times that of the reference aortic diameter
    4. Saccular aneurysm
  5. Subject has access vessel size compatible with vascular access techniques and potential accessories used with delivery profile of 14Fr
  6. Subject aortic aneurysm neck is ≥15 mm in length
  7. Subject iliac landing zone≥10mm in length
  8. Subject has distal iliac landing sites with diameter ranges of 9-18mm
  9. Subject proximal aortic attachment is between 20-27 mm in diameter.
  10. Subject has a minimum overall AAA treatment length (from lowest renal artery to distal landing zone) of 140 mm.
  11. Subject is willing to comply with all specified follow-up evaluations.

EXCLUSION CRITERIA:

  1. Subject has one of the following:

    1. a dissecting or inflammatory aneurysm
    2. acutely ruptured aneurysm
    3. pararenal or leaking aneurysm
  2. The supra-renal aorta at 2cm above the lowest renal aorta is not more than the nominal diameter of the aortic bifurcate prosthesis
  3. Aortic length (lowest renal artery origin to the aortic bifurcation) of <8.7 cm
  4. Circumferential thrombosis and/or calcification ≥50% in the aortic and iliac landing zones
  5. Circumferential thrombosis and/or calcification ≥50% in the supra-renal aorta
  6. Subject has aneurysm neck angulations that are >60° in the supra-renal and/or infra-renal locations
  7. Aortic bifurcation ≤18mm in diameter
  8. Acute vascular injury due to trauma
  9. Subject has a known allergy to contrast medium
  10. Subject has known allergy to nitinol, PET or PTFE
  11. Subject has a need for emergent surgery
  12. Subject has a contraindication to undergoing angiography
  13. Subject has a thoracic aortic aneurysm that requires treatment
  14. Subject has Infra-renal aortic dissection
  15. Subject has an Iliac anatomy which would require occlusion of both internal iliac arteries
  16. Subject has congenital abnormalities in which the placement of the stent-graft will cause occlusion of major arterial flow. Such abnormalities should be evaluated (e.g. angiography or CT) prior to treatment
  17. Subject has unstable angina as defined by Braunwald angina classification
  18. Subject has morbid obesity (BMI of >40.0) or other clinical conditions that severely inhibit visualization of the aorta
  19. Subject has connective tissue disease (e.g., Marfan's or Ehler's-Danos syndrome)
  20. Subject has known bleeding or hypercoagulable disorder
  21. Subject has contraindication for anticoagulation
  22. Subject with Stroke or MI or intracranial bleeding within 3 months prior to the procedure
  23. Subject with renal insufficiency (creatinine > 2.0 mg/dl)
  24. Subject has known or suspected active infection at the time of the index procedure (for ex. Pneumonia, acute virus infection, contaminated wounds etc)
  25. Subject is currently taking systemic immunosuppressant therapy
  26. Subject had a major surgical procedure within 30 days prior to procedure or planned within 30 days post procedure
  27. Subject has a life expectancy less than 2 years
  28. Subject is currently participating in another research study involving an investigational device or new drug
  29. Other medical, social, or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment
  30. Subject with an existing AAA surgical graft and/or a AAA stent-graft system

Sites / Locations

  • Universitat Leipzig Herzzentrum

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AAA stent graft system

Arm Description

Cordis AAA stent graft system "INCRAFT TM"

Outcomes

Primary Outcome Measures

Rate of Technical Success Through the One Month Follow up.
Technical success is defined as the successful deployment of the stent-graft to the desired location in the absence of Types I, III or IV endoleaks at the conclusion of the procedure and through the one month follow up.
Rate of Primary Safety Endpoint Within 1 Month Post-procedure.
Primary safety is defined by the absence of Types I, III or IV endoleaks and device and/or procedural related major adverse events within 1 month post-procedure. Major adverse events include death, MI, stroke and renal failure.

Secondary Outcome Measures

Percentage of Participants With Incidence of Aneurysm Enlargement Annually Through 5 Years Post - Procedure.
Incidence of aneurysm enlargement annually through 5 years post - procedure. Aneurysm enlargement is defined as being compared to the 30 day baseline assessment.
Percentage of Participants With Incidence of Stent-graft Migration Annually Through 5 Years Post - Procedure.
Incidence of Stent-graft Migration annually through 5 years post - procedure. Stent-graft Migration is defined as being compared to the 30 day baseline assessment.
The Cumulative Percentage of Participants With Major Adverse Events at Annually Through 5 Years Post - Procedure.
The cumulative percentage of participants with Major Adverse Events (MAE) at annually through 5 years post - procedure; i.e., the percentage of MAE at Year 1 includes all MAEs occurred during the first year, the percentage at Year 2 includes all MAEs during the first two years, and etc. The Major adverse events include death, stroke, Q wave myocardial infarction, and renal failure
The Percentage of Participants With Endoleaks at Annually Through 5 Years Post - Procedure.
The percentage of endoleaks at annually through 5 years post - procedure. Endoleak contains Types I and III endoleaks
The Percentage of Participants With Stent-graft Fractures at 30 Days and Annually Through 5 Years Post - Procedure.
The percentage of stent-graft fracture at 30 days and annually through 5 years post - procedure. Stent-graft fracture is defined as stent skeleton fracture and barb separation
The Percentage of Participants With Thrombosis at 30 Days and Annually Through 5 Years Post - Procedure.
The percentage of Thrombosis at hospital discharge at 30 days and annually through 5 years post - procedure.
The Percentage of Participants With Stent Graft Explant at 30 Days and Annually Through 5 Years Post - Procedure.
The percentage of Stent Graft Explant at hospital discharge at 30 days and annually through 5 years post - procedure.
The Percentage of Participants With Endoleg Patency at 30 Days and Annually Through 5 Years Post - Procedure.
The percentage of participants with Endoleg Patency by CT scan at 30 days and annually through 5 years post - procedure.

Full Information

First Posted
April 16, 2010
Last Updated
April 14, 2022
Sponsor
Cordis Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01106391
Brief Title
A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With AAA (INNOVATION)
Acronym
INNOVATION
Official Title
A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With Abdominal Aortic Aneurysms
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cordis Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a multi-center prospective, open label, non-randomized investigation of INCRAFT™ in subjects with abdominal aortic aneurysms. The study will enroll up to 60 subjects in up to 7 sites in Germany and Italy.
Detailed Description
This study is a multi-center prospective, open label, non-randomized investigation of INCRAFT™ in subjects with abdominal aortic aneurysms. The study will enroll up to 60 subjects at 7 sites in Germany and Italy. All treated subjects will be evaluated at 1 month, 3 months (if applicable), 6 and 12 months, and annually for a total of 5 years post-procedure. An interim analysis will be conducted after the 25th enrolled subject reaches the 30-day follow up visit

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysms
Keywords
Abdominal aortic aneurysm, AAA, Safety, Performance, Stent graft system, First in Human, Endovascular repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AAA stent graft system
Arm Type
Experimental
Arm Description
Cordis AAA stent graft system "INCRAFT TM"
Intervention Type
Device
Intervention Name(s)
Cordis AAA stent graft system "INCRAFT TM"
Primary Outcome Measure Information:
Title
Rate of Technical Success Through the One Month Follow up.
Description
Technical success is defined as the successful deployment of the stent-graft to the desired location in the absence of Types I, III or IV endoleaks at the conclusion of the procedure and through the one month follow up.
Time Frame
From procedure to one month follow up
Title
Rate of Primary Safety Endpoint Within 1 Month Post-procedure.
Description
Primary safety is defined by the absence of Types I, III or IV endoleaks and device and/or procedural related major adverse events within 1 month post-procedure. Major adverse events include death, MI, stroke and renal failure.
Time Frame
One month follow-up
Secondary Outcome Measure Information:
Title
Percentage of Participants With Incidence of Aneurysm Enlargement Annually Through 5 Years Post - Procedure.
Description
Incidence of aneurysm enlargement annually through 5 years post - procedure. Aneurysm enlargement is defined as being compared to the 30 day baseline assessment.
Time Frame
Day 30 through year 5 post-procedure
Title
Percentage of Participants With Incidence of Stent-graft Migration Annually Through 5 Years Post - Procedure.
Description
Incidence of Stent-graft Migration annually through 5 years post - procedure. Stent-graft Migration is defined as being compared to the 30 day baseline assessment.
Time Frame
Day 30 through year 5 post-procedure
Title
The Cumulative Percentage of Participants With Major Adverse Events at Annually Through 5 Years Post - Procedure.
Description
The cumulative percentage of participants with Major Adverse Events (MAE) at annually through 5 years post - procedure; i.e., the percentage of MAE at Year 1 includes all MAEs occurred during the first year, the percentage at Year 2 includes all MAEs during the first two years, and etc. The Major adverse events include death, stroke, Q wave myocardial infarction, and renal failure
Time Frame
From day 1 through year 5 post-procedure
Title
The Percentage of Participants With Endoleaks at Annually Through 5 Years Post - Procedure.
Description
The percentage of endoleaks at annually through 5 years post - procedure. Endoleak contains Types I and III endoleaks
Time Frame
From day 1 through year 5 post-procedure
Title
The Percentage of Participants With Stent-graft Fractures at 30 Days and Annually Through 5 Years Post - Procedure.
Description
The percentage of stent-graft fracture at 30 days and annually through 5 years post - procedure. Stent-graft fracture is defined as stent skeleton fracture and barb separation
Time Frame
From day 1 through year 5 post-procedure
Title
The Percentage of Participants With Thrombosis at 30 Days and Annually Through 5 Years Post - Procedure.
Description
The percentage of Thrombosis at hospital discharge at 30 days and annually through 5 years post - procedure.
Time Frame
From day 1 through year 5 post-procedure
Title
The Percentage of Participants With Stent Graft Explant at 30 Days and Annually Through 5 Years Post - Procedure.
Description
The percentage of Stent Graft Explant at hospital discharge at 30 days and annually through 5 years post - procedure.
Time Frame
From day 1 through year 5 post-procedure
Title
The Percentage of Participants With Endoleg Patency at 30 Days and Annually Through 5 Years Post - Procedure.
Description
The percentage of participants with Endoleg Patency by CT scan at 30 days and annually through 5 years post - procedure.
Time Frame
From day 1 through year 5 post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: Subject is a male or infertile female > 18 years of age Subject understands study requirements and treatment procedures and agrees to sign an informed consent form prior to any study procedures. Subject is considered an appropriate candidate for open surgical repair of an abdominal aortic aneurysm. Subject has at least one of the following: Abdominal aortic aneurysm ≥4.5 cm in women or ≥ 5 cm in men in diameter Aneurysm, which is >4 cm and which has increased in size by 0.5 cm within 6 months The maximum aortic diameter is ≥1.5 times that of the reference aortic diameter Saccular aneurysm Subject has access vessel size compatible with vascular access techniques and potential accessories used with delivery profile of 14Fr Subject aortic aneurysm neck is ≥15 mm in length Subject iliac landing zone≥10mm in length Subject has distal iliac landing sites with diameter ranges of 9-18mm Subject proximal aortic attachment is between 20-27 mm in diameter. Subject has a minimum overall AAA treatment length (from lowest renal artery to distal landing zone) of 140 mm. Subject is willing to comply with all specified follow-up evaluations. EXCLUSION CRITERIA: Subject has one of the following: a dissecting or inflammatory aneurysm acutely ruptured aneurysm pararenal or leaking aneurysm The supra-renal aorta at 2cm above the lowest renal aorta is not more than the nominal diameter of the aortic bifurcate prosthesis Aortic length (lowest renal artery origin to the aortic bifurcation) of <8.7 cm Circumferential thrombosis and/or calcification ≥50% in the aortic and iliac landing zones Circumferential thrombosis and/or calcification ≥50% in the supra-renal aorta Subject has aneurysm neck angulations that are >60° in the supra-renal and/or infra-renal locations Aortic bifurcation ≤18mm in diameter Acute vascular injury due to trauma Subject has a known allergy to contrast medium Subject has known allergy to nitinol, PET or PTFE Subject has a need for emergent surgery Subject has a contraindication to undergoing angiography Subject has a thoracic aortic aneurysm that requires treatment Subject has Infra-renal aortic dissection Subject has an Iliac anatomy which would require occlusion of both internal iliac arteries Subject has congenital abnormalities in which the placement of the stent-graft will cause occlusion of major arterial flow. Such abnormalities should be evaluated (e.g. angiography or CT) prior to treatment Subject has unstable angina as defined by Braunwald angina classification Subject has morbid obesity (BMI of >40.0) or other clinical conditions that severely inhibit visualization of the aorta Subject has connective tissue disease (e.g., Marfan's or Ehler's-Danos syndrome) Subject has known bleeding or hypercoagulable disorder Subject has contraindication for anticoagulation Subject with Stroke or MI or intracranial bleeding within 3 months prior to the procedure Subject with renal insufficiency (creatinine > 2.0 mg/dl) Subject has known or suspected active infection at the time of the index procedure (for ex. Pneumonia, acute virus infection, contaminated wounds etc) Subject is currently taking systemic immunosuppressant therapy Subject had a major surgical procedure within 30 days prior to procedure or planned within 30 days post procedure Subject has a life expectancy less than 2 years Subject is currently participating in another research study involving an investigational device or new drug Other medical, social, or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment Subject with an existing AAA surgical graft and/or a AAA stent-graft system
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dierk Scheinert, PhD, MD.
Organizational Affiliation
Universität Leipzig - Herzzentrum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitat Leipzig Herzzentrum
City
Leipzig
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23332982
Citation
Scheinert D, Pratesi C, Chiesa R, Coppi G, Brunkwall JS, Klarenbeek G, Cebrian A, Torsello G. First-in-human study of the INCRAFT endograft in patients with infrarenal abdominal aortic aneurysms in the INNOVATION trial. J Vasc Surg. 2013 Apr;57(4):906-14. doi: 10.1016/j.jvs.2012.09.079. Epub 2013 Jan 18.
Results Reference
background
PubMed Identifier
21894137
Citation
Torsello G, Brunkwall J, Scheinert D. Cordis INCRAFT ultra-low profile AAA stent-graft system. J Cardiovasc Surg (Torino). 2011 Oct;52(5):661-7.
Results Reference
background
PubMed Identifier
24356046
Citation
Coppi G, Njila M, Coppi G, Saitta G, Silingardi R, Pratesi C, Chiesa R, Scheinert D, Brunkwall JS, Torsello G. INCRAFT(R) Stent-Graft System: one-year outcome of the INNOVATION Trial. J Cardiovasc Surg (Torino). 2014 Feb;55(1):51-9.
Results Reference
background
PubMed Identifier
25053535
Citation
Torsello G, Scheinert D, Brunkwall JS, Chiesa R, Coppi G, Pratesi C. Safety and effectiveness of the INCRAFT AAA Stent Graft for endovascular repair of abdominal aortic aneurysms. J Vasc Surg. 2015 Jan;61(1):1-8. doi: 10.1016/j.jvs.2014.06.007. Epub 2014 Jul 19.
Results Reference
background
PubMed Identifier
30591290
Citation
Torsello G, Pratesi G, van der Meulen S, Ouriel K; INNOVATION trial collaborators. Aortoiliac remodeling and 5-year outcome of an ultralow-profile endograft. J Vasc Surg. 2019 Jun;69(6):1747-1757. doi: 10.1016/j.jvs.2018.09.059. Epub 2018 Dec 24.
Results Reference
derived

Learn more about this trial

A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With AAA (INNOVATION)

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