A Multicenter, Open Label, Prospective, Non-randomized Study of the InCraft® Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INSPIRATION)

Completed · Not applicable

Conditions studied: Abdominal Aortic Aneurysm

In brief

The purpose of this study is to evaluate the safety and effectiveness of InCraft® in subjects with abdominal aortic aneurysms requiring endovascular repair.

Key facts

Study ID

NCT01664078

Run by

Cordis US Corp.

People needed

190

Starts

2012-07-01

Expected to finish

2018-10-10

Last updated by the study team

2024-07-03

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must meet ALL of the following inclusion criteria to be enrolled in the study:
• Male or Female age 20 years or older;
• Proximal aortic neck is 17-31mm in diameter;
• Supra-renal aorta, at 20mm above the anticipated landing location, is smaller than the nominal diameter of the aortic bifurcate prosthesis to be used;
• Infra-renal aortic neck is ≥10mm in length with supra-renal and infra-renal angulations ≤60°;
• Subject has at least one of the following:
• AAA size > 5.0 cm;
• Increase of the AAA diameter of > 0.5 cm over the last 6 months;
• Abdominal treatment length (lowest renal artery origin to the aortic bifurcation) ≥ 9.4cm;
• Aortic bifurcation >18mm in diameter;
• Iliac landing zone ≥15mm in length;
• Iliac landing zone 7-22mm in diameter;
• Minimum access vessel size of ≥ 5mm;
• Minimum overall AAA treatment length (from lowest renal artery to distal landing zone) of 128 mm;
• Women of child bearing potential must be non-pregnant, non-lactating, and not planning to become pregnant during the course of the trial; and have a negative urine or serum pregnancy test within 7 days prior to index procedure;
• Provide written informed consent and as applicable written HIPAA authorization (For US sites only) prior to initiation of study procedures;
• Willing to comply with the specified follow-up evaluation schedule.

You may not qualify if…

• Subjects will be excluded if ANY of the following exclusion criteria apply:
• Vascular anatomy in which the placement of the stent-graft will cause occlusion of both internal iliac arteries or necessitates surgical occlusion of both internal iliac arteries;
• Subject has one of the following:
• Aneurysm sac rupture or leaking abdominal aortic aneurysm;
• Mycotic, dissecting, or inflammatory abdominal aortic aneurysm;
• Clinically significant acute vascular injury due to trauma;
• Significant aortic or iliac mural thrombus, plaque or calcification that would compromise fixation and seal of the device;
• A conical aortic neck defined as >3mm distal increase over a 10mm length in the planned seal zone;
• Thoracic aortic aneurysm ≥45mm;
• Any aortic dissection;
• Morbid obesity (BMI >40.0 kg.m2) or other clinical conditions that limit required imaging studies or visualization of the aorta;
• Renal insufficiency (Creatinine > 2.0mg/dL) or subject on renal dialysis;
• Known allergy or intolerance to nickel titanium (nitinol) , Polyethylene terephthalate (PET), or polytetrafluoroethylene (PTFE);
• Known contraindication to undergoing angiography or anticoagulation (e.g. contrast allergies which cannot be treated);
• Connective tissue disorder (such as Marfan's Syndrome or Ehlers-Danlos Syndrome);
• Coagulopathy, bleeding disorder, or other hypercoagulable state;
• Organ transplant recipient or subject requiring systemic immunosuppressant therapy;
• Cerebral vascular accident (CVA), MI, or intracranial bleeding within 3 months prior to the procedure;
• Active infection or chronic systemic illness at the time of index procedure that may interfere with the study objectives;
• Major surgical procedure within 1 month prior to the index procedure or pre-planned within 1 month afterwards;
• Co-existing condition with a life expectancy of less than 2 years at time of procedure;
• Current or planned participation in any other investigational drug or medical device clinical study that has not completed primary endpoint(s) evaluation;
• Existing AAA surgical graft and/or a AAA stent-graft system;
• Other medical, social, or psychological issues that in the opinion of the investigator preclude the subjects from receiving this treatment, and the procedures and evaluations pre- and posttreatment.

Where it is running

• Michel S. Makaroun, MD — Pittsburgh, Pennsylvania, United States
• Takao Ohki, MD — Minato-ku, Tokyo, Japan

Full record on ClinicalTrials.gov

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