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

A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With Abdominal Aortic Aneurysms

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01106391

Acronym

INNOVATION

Enrollment

Registered

2010-04-19

Start date

2010-03-31

Completion date

2016-10-31

Last updated

2023-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Aortic Aneurysms

Keywords

Abdominal aortic aneurysm, AAA, Safety, Performance, Stent graft system, First in Human, Endovascular repair

Brief summary

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

Interventions

DEVICECordis AAA stent graft system INCRAFT TM

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Rate of Technical Success Through the One Month Follow up.	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.	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.

Secondary

Measure	Time frame	Description
The Cumulative Percentage of Participants With Major Adverse Events at Annually Through 5 Years Post - Procedure.	From day 1 through year 5 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 Stent Graft Explant at 30 Days and Annually Through 5 Years Post - Procedure.	From day 1 through year 5 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 Endoleaks at Annually Through 5 Years Post - Procedure.	From day 1 through year 5 post-procedure	The percentage of endoleaks at annually through 5 years post - procedure. Endoleak contains Types I and III endoleaks
Percentage of Participants With Incidence of Aneurysm Enlargement Annually Through 5 Years Post - Procedure.	Day 30 through year 5 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.
The Percentage of Participants With Endoleg Patency at 30 Days and Annually Through 5 Years Post - Procedure.	From day 1 through year 5 post-procedure	The percentage of participants with Endoleg Patency by CT scan at 30 days and annually through 5 years post - procedure.
The Percentage of Participants With Thrombosis at 30 Days and Annually Through 5 Years Post - Procedure.	From day 1 through year 5 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 Fractures at 30 Days and Annually Through 5 Years Post - Procedure.	From day 1 through year 5 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
Percentage of Participants With Incidence of Stent-graft Migration Annually Through 5 Years Post - Procedure.	Day 30 through year 5 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.

Countries

Germany

Participant flow

Recruitment details

There were 60 subjects enrolled in this trial at 7 sites in Germany and Italy from March 19, 2010 to June 20, 2011.

Pre-assignment details

Of the 78 subjects consented and assessed for eligibility, 18 subjects did not meet all study entrance criteria and were considered screen failure.

Participants by arm

Arm	Count
The INCRAFT™ AAA Stent-graft System The Cordis INCRAFT™ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents.	60
Total	60

Arm

Count

The INCRAFT™ AAA Stent-graft System

The Cordis INCRAFT™ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents.

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	12
Overall Study	Withdrawal by Subject	7

Baseline characteristics

Characteristic	The INCRAFT™ AAA Stent-graft System
Age, Continuous	74.4 years STANDARD_DEVIATION 6.93
Body mass index	26.7 kg/m² STANDARD_DEVIATION 3.05
Diabetes Free of diabetes	47 Participants
Diabetes Insulin-dependent diabetes	3 Participants
Diabetes Non-insulin-dependent diabetes	10 Participants
Hypertension Free of Hypertension	3 Participants
Hypertension Hypertension	57 Participants
Region of Enrollment Germany	31 Participants
Region of Enrollment Italy	29 Participants
Sex: Female, Male Female	3 Participants
Sex: Female, Male Male	57 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	44 / 60
serious Total, serious adverse events	8 / 60

Outcome results

Primary

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.

Time frame: One month follow-up

Population: The analysis population consists of subjects with complete core laboratory data at 1 month.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
The INCRAFT™ AAA Stent-graft System	Rate of Primary Safety Endpoint Within 1 Month Post-procedure.	56 Participants

Comparison: Since this was a feasibility study without comparisons, sample size was not determined based on statistical consideration. No formal hypothesis testing was performed either.95% CI: [88.1, 99.6]

Primary

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.

Time frame: From procedure to one month follow up

Population: All enrolled subjects

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
The INCRAFT™ AAA Stent-graft System	Rate of Technical Success Through the One Month Follow up.	54 Participants

Secondary

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.

Time frame: Day 30 through year 5 post-procedure

Population: All enrolled subjects. However at each annual assessment of aneurysm enlargement, the numbers of follow-up subjects are 53, 50, 45, 39, 38 at year 1 through 5 respectively.

Arm	Measure	Group	Value (NUMBER)
The INCRAFT™ AAA Stent-graft System	Percentage of Participants With Incidence of Aneurysm Enlargement Annually Through 5 Years Post - Procedure.	Year 1	0.0 percentage of subjects with endpoint
The INCRAFT™ AAA Stent-graft System	Percentage of Participants With Incidence of Aneurysm Enlargement Annually Through 5 Years Post - Procedure.	Year 2	0.0 percentage of subjects with endpoint
The INCRAFT™ AAA Stent-graft System	Percentage of Participants With Incidence of Aneurysm Enlargement Annually Through 5 Years Post - Procedure.	Year 3	4.4 percentage of subjects with endpoint
The INCRAFT™ AAA Stent-graft System	Percentage of Participants With Incidence of Aneurysm Enlargement Annually Through 5 Years Post - Procedure.	Year 4	10.3 percentage of subjects with endpoint
The INCRAFT™ AAA Stent-graft System	Percentage of Participants With Incidence of Aneurysm Enlargement Annually Through 5 Years Post - Procedure.	Year 5	7.9 percentage of subjects with endpoint

Secondary

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.

Time frame: Day 30 through year 5 post-procedure

Population: All enrolled subjects. However at each annual assessment of Stent-graft Migration, the numbers of follow-up subjects are 53, 50, 44, 38, 37 at year 1 through 5 respectively.

Arm	Measure	Group	Value (NUMBER)
The INCRAFT™ AAA Stent-graft System	Percentage of Participants With Incidence of Stent-graft Migration Annually Through 5 Years Post - Procedure.	Year 1	0.0 percentage of subjects with endpoint
The INCRAFT™ AAA Stent-graft System	Percentage of Participants With Incidence of Stent-graft Migration Annually Through 5 Years Post - Procedure.	Year 2	0.0 percentage of subjects with endpoint
The INCRAFT™ AAA Stent-graft System	Percentage of Participants With Incidence of Stent-graft Migration Annually Through 5 Years Post - Procedure.	Year 3	0.0 percentage of subjects with endpoint
The INCRAFT™ AAA Stent-graft System	Percentage of Participants With Incidence of Stent-graft Migration Annually Through 5 Years Post - Procedure.	Year 4	0.0 percentage of subjects with endpoint
The INCRAFT™ AAA Stent-graft System	Percentage of Participants With Incidence of Stent-graft Migration Annually Through 5 Years Post - Procedure.	Year 5	0.0 percentage of subjects with endpoint

Secondary

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