Clinical Study of Aneurysm Exclusion

Launched by ARIZONA HEART INSTITUTE · Oct 24, 2007

Keywords

ClinConnect Summary

The Arizona Heart Institute is respectfully submitting this protocol for a feasibility study utilizing the endoluminal grafts constructed of PTFE encapsulated nitinol stents. The study is intended to evaluate the use of this unique device in the treatment of aortic aneurysmal disease. The stent graft is made by laminating a PTFE "jacket" around nitinol stents which act as structural and fixation supports. Both materials have an extensive history of use in various types of implanted devices. CT scans and angiography or 3D computer imaging, and possibly IVUS imaging will be used to choose the...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aneurysm diameter ≥ 4.0 cm; or aneurysm diameter ≤ 4.0 cm which has exhibited rapid expansion; or aneurysms with saccular configuration where potential for rupture is increased; or aneurysms which have exhibited dissection and there is potential for rupture or compromised flow to vital structures; or symptomatic leaking or ruptured aneurysms.
• • Vessels proximal and distal to the lesion must be capable of accommodating the device.
• • The access artery diameter and profile of the artery must be capable of the device delivery.
• • Patients must be ASA III or higher.
• • Informed consent must be obtainable.
• • Patients must be willing and able to comply with the follow-up regime.
• * Patients with neck grades as follow:
• • Grade I: Length of Proximal Neck ≥ 1.5 cm and Distal Neck ≥ 1.0 cm
• • Grade II: Length of Proximal Neck ≥ 1.5 cm, but Distal Neck \< 1.0 cm without obvious iliac aneurysms, or aneurysm extends into or is associated with iliac aneurysms.
• • Grade III: Length of Proximal Neck \< 1.5 cm and Distal Neck ≥ 1.0 cm
• • Grade IV: Length of Proximal Neck \< 1.5 cm and Distal Neck \< 1.0 cm or the involvement as in Grade II.
• Exclusion Criteria:
• • A proximal neck less than 0.5 cm in length.
• • Arterial diameter larger than 40 mm at the proximal or distal landing zones.
• • Iliac diameter less than 6 mm (following balloon angioplasty as needed).
• • The inferior mesenteric artery is indispensable.
• • Patients under the age of 18.
• • Pregnant or lactating women.
• • Patients with allergy to any of the device materials.
• • Patients with uncorrectable coagulopathy or bleeding disorders.
• • Patients for whom contrast medium or anticoagulation drugs are contraindicated.
• • Patients with active systemic or localized groin infection.