Pilot Study of the Endologix Fenestrated Stent Graft System

Endologix

Status

Completed

Conditions

Pararenal Aortic Aneurysm

Juxtarenal Aortic Aneurysm

Treatments

Device: Ventana Fenestrated Stent Graft System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01437215

CP-0002

Details and patient eligibility

About

The purpose of this study is to determine whether the Endologix fenestrated stent graft system is safe and feasible in the endovascular repair of juxtarenal or pararenal aortic aneurysm.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Informed consent understood and signed and pt agrees to all follow-up visits;
Abdominal aortic aneurysm with diameter ≥5cm or ≥4cm which has increased by 0.5cm or more in the past six months
Adequate iliac/femoral access compatible with the required delivery systems
Non-aneurysmal infrarenal aortic neck <15mm in length
Most caudal renal artery to aortoiliac bifurcation length at least 70mm
Proximal non-aneurysmal aortic neck below the SMA with: diameter 18 to 34 mm; length at least 15 mm; angle (clock face) <60° to the aneurysm sac;
Angle <60° (clock face) between the SMA and celiac artery
Renal arteries both distal to the SMA by 0-35mm, within 30mm of each other axially, with 4 to 8mm lumen diameter, and with clockface angle of 90° to 210° to each other
Iliac anatomy suitable for commercial bifurcated stent graft;
Minimum 3cm overlap achievable between fenestrated and bifurcated stent grafts

Exclusion criteria

Life expectancy <1 year as judged by the investigator;
Psychiatric or other condition that may interfere with the study;
Participating in the enrollment or 30-day follow-up phase of another clinical study;
Known allergy to any device component;
Coagulopathy or uncontrolled bleeding disorder;
Contraindication to contrast media or anticoagulants;
Ruptured, leaking, dissecting, or mycotic aneurysm;
Serum creatinine (S-Cr) level >2.0 mg/dL;
Traumatic vascular injury;
Active systemic or localized groin infection;
Connective tissue disease (e.g., Marfan's Syndrome);
Recent (within prior three months) cerebrovascular accident or myocardial infarction;
Prior renal transplant;
Length of either renal artery to be stented <13mm;
Significant occlusive disease or calcification of either renal artery;
An essential accessory renal artery;
Indispensable inferior mesenteric artery;
Untreated aneurysmal disease of the descending thoracic aorta;
Clinically significant mural thrombus circumferentially in the suprarenal segment;
Prior iliac artery stent implanted that may interfere with delivery system introduction;
Unsuitable vascular anatomy
Pregnancy (female patient of childbearing potential only)