Abdominal Aortic AneurysmsINNOVATIONNCT01106391
A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With AAA (INNOVATION)
A study testing Cordis AAA stent graft system "INCRAFT TM" in people with Abdominal Aortic Aneurysms, run by Cordis US Corp. at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysms
- What is being tested?
- Cordis AAA stent graft system "INCRAFT TM"
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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.
Who cannot join
- 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
Show all 33Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With Abdominal Aortic Aneurysms
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.
Read the 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
- Conditions
- Abdominal Aortic Aneurysms
- Being tested
- Cordis AAA stent graft system "INCRAFT TM"
- Keywords
- Abdominal aortic aneurysm, AAA, Safety, Performance, Stent graft system, First in Human, Endovascular repair
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cordis AAA stent graft system "INCRAFT TM"Device
| Study group | Role | What they receive |
|---|---|---|
| AAA stent graft system | Experimental | Cordis AAA stent graft system "INCRAFT TM" Receives: Device: Cordis AAA stent graft system "INCRAFT TM" |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From procedure to 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.
Measured: One month follow-up
Secondary outcomes (8)
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.
Measured: Day 30 through year 5 post-procedure
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.
Measured: Day 30 through year 5 post-procedure
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
Measured: From day 1 through year 5 post-procedure
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
Measured: From day 1 through year 5 post-procedure
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
Measured: From day 1 through year 5 post-procedure
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.
Measured: From day 1 through year 5 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.
Measured: From day 1 through year 5 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.
Measured: From day 1 through year 5 post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionAug 2011
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dierk Scheinert, PhD, MD., Principal investigator, Universität Leipzig - Herzzentrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106391
- Sponsor's protocol ID
- EE09-01
- Acronym
- INNOVATION
- Status last verified
- Apr 2022
- First submitted
- 16 Apr 2010
- Last updated
- 12 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 23332982Torsello G, Brunkwall J, Scheinert D. Cordis INCRAFT ultra-low profile AAA stent-graft system. J Cardiovasc Surg (Torino). 2011 Oct;52(5):661-7.
PubMed 21894137Coppi 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.
PubMed 24356046Torsello 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.
PubMed 25053535Torsello 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.
PubMed 30591290
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With Abdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT01106391
- Acronym / sponsor ID
- INNOVATION / EE09-01
- Conditions
- Abdominal Aortic Aneurysms
- Keywords
- Abdominal aortic aneurysm, AAA, Safety, Performance, Stent graft system, First in Human, Endovascular repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 19 Apr 2010 (estimated)
- Results
- Posted 26 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AAA stent graft system | Experimental | Device: Cordis AAA stent graft system "INCRAFT TM"Cordis AAA stent graft system "INCRAFT TM" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- Subject has access vessel size compatible with vascular access techniques and potential accessories used with delivery profile of 14Fr
Key exclusion criteria (33 listed)
- Subject has one of the following:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cordis AAA stent graft system "INCRAFT TM" | Device | AAA stent graft system |
Primary outcome
Rate of Technical Success Through the One Month Follow up.
Time frame: From procedure to 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.
Time frame: One month follow-up
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.
8 secondary outcomes
Percentage of Participants With Incidence of Aneurysm Enlargement Annually Through 5 Years Post - Procedure.
Time frame: Day 30 through year 5 post-procedure
Percentage of Participants With Incidence of Stent-graft Migration Annually Through 5 Years Post - Procedure.
Time frame: Day 30 through year 5 post-procedure
The Cumulative Percentage of Participants With Major Adverse Events at Annually Through 5 Years Post - Procedure.
Time frame: From day 1 through year 5 post-procedure
The Percentage of Participants With Endoleaks at Annually Through 5 Years Post - Procedure.
Time frame: From day 1 through year 5 post-procedure
The Percentage of Participants With Stent-graft Fractures at 30 Days and Annually Through 5 Years Post - Procedure.
Time frame: From day 1 through year 5 post-procedure
The Percentage of Participants With Thrombosis at 30 Days and Annually Through 5 Years Post - Procedure.
Time frame: From day 1 through year 5 post-procedure
The Percentage of Participants With Stent Graft Explant at 30 Days and Annually Through 5 Years Post - Procedure.
Time frame: From day 1 through year 5 post-procedure
The Percentage of Participants With Endoleg Patency at 30 Days and Annually Through 5 Years Post - Procedure.
Time frame: From day 1 through year 5 post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23332982Scheinert 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.
- Background: PubMed 21894137Torsello G, Brunkwall J, Scheinert D. Cordis INCRAFT ultra-low profile AAA stent-graft system. J Cardiovasc Surg (Torino). 2011 Oct;52(5):661-7.
- Background: PubMed 24356046Coppi 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.
- Background: PubMed 25053535Torsello 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.
- Derived from this study: PubMed 30591290Torsello 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.
- Individual participant dataSharing planned: No
Related trials for Abdominal Aortic Aneurysms
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Active, not recruiting
ANEUFIX for Endoleak Type II Repair
Abdominal Aortic Aneurysm, Endoleak
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dierk Scheinert, PhD, MD. principal investigator
Universität Leipzig - Herzzentrum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cordis AAA stent graft system "INCRAFT TM" in people with Abdominal Aortic Aneurysms, run by Cordis US Corp. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Technical Success Through the One Month Follow up. (time frame: From procedure to one month follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01106391, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.