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

Cordis

Status

Completed

Conditions

Abdominal Aortic Aneurysms

Treatments

Device: Cordis AAA stent graft system "INCRAFT TM"

Study type

Interventional

Funder types

Industry

Identifiers

NCT01106391

EE09-01

Details and patient eligibility

About

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.

Full 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

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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:
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
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:
1. a dissecting or inflammatory aneurysm
2. acutely ruptured aneurysm
3. 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