Clinical Study of Aneurysm Exclusion

Status unconfirmed · Not applicable

Conditions studied: Aneurysm

In brief

The ultimate purpose is to explore the potential techniques to exclude aneurysms and provide an alternative conduit for arterial flow. The single center sponsorship is intended to provide the investigators the potential to incorporate improvements in existing technology during the course of the study thereby ultimately enhancing the potential for superior medical care of patients suffering from these disease states. The sponsor/investigator recognizes and accepts responsibility to notify and receive approval from the agency when device modifications are made that may affect patient safety.

Key facts

Study ID

NCT00549016

Run by

Arizona Heart Institute

People needed

150

Starts

2002-11-01

Expected to finish

2012-11-01

Last updated by the study team

2009-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Arizona Heart Institute — Phoenix, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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