Trial Outcomes & Findings for A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With AAA (INNOVATION) (NCT NCT01106391)

Last Updated: 2023-01-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

From procedure to one month follow up

Results posted on

2023-01-12

Participant Flow

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

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

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	60
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Death	12
Overall Study Withdrawal by Subject	7

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	The INCRAFT™ AAA Stent-graft System n=60 Participants 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.
Age, Continuous	74.4 years STANDARD_DEVIATION 6.93 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants
Region of Enrollment Germany	31 Participants n=5 Participants
Region of Enrollment Italy	29 Participants n=5 Participants
Body mass index	26.7 kg/m² STANDARD_DEVIATION 3.05 • n=5 Participants
Diabetes Insulin-dependent diabetes	3 Participants n=5 Participants
Diabetes Non-insulin-dependent diabetes	10 Participants n=5 Participants
Diabetes Free of diabetes	47 Participants n=5 Participants
Hypertension Hypertension	57 Participants n=5 Participants
Hypertension Free of Hypertension	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: From procedure to one month follow up

Population: All enrolled subjects

Outcome measures

Outcome measures
Measure	The INCRAFT™ AAA Stent-graft System n=60 Participants 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.
Rate of Technical Success Through the One Month Follow up.	54 Participants

PRIMARY outcome

Timeframe: One month follow-up

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

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.

Outcome measures

Outcome measures
Measure	The INCRAFT™ AAA Stent-graft System n=58 Participants 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.
Rate of Primary Safety Endpoint Within 1 Month Post-procedure.	56 Participants

SECONDARY outcome

Timeframe: 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.

Incidence of aneurysm enlargement annually through 5 years post - procedure. Aneurysm enlargement is defined as being compared to the 30 day baseline assessment.

Outcome measures

Outcome measures
Measure	The INCRAFT™ AAA Stent-graft System n=60 Participants 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.
Percentage of Participants With Incidence of Aneurysm Enlargement Annually Through 5 Years Post - Procedure. Year 1	0.0 percentage of subjects with endpoint
Percentage of Participants With Incidence of Aneurysm Enlargement Annually Through 5 Years Post - Procedure. Year 2	0.0 percentage of subjects with endpoint
Percentage of Participants With Incidence of Aneurysm Enlargement Annually Through 5 Years Post - Procedure. Year 3	4.4 percentage of subjects with endpoint
Percentage of Participants With Incidence of Aneurysm Enlargement Annually Through 5 Years Post - Procedure. Year 4	10.3 percentage of subjects with endpoint
Percentage of Participants With Incidence of Aneurysm Enlargement Annually Through 5 Years Post - Procedure. Year 5	7.9 percentage of subjects with endpoint

SECONDARY outcome

Timeframe: 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.

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.