Recruiting

Aneurysm ExclusionClinical Study of Aneurysm Exclusion

Sponsor:

Arizona Heart Institute

Code:

NCT00549016

Conditions

Aneurysm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PTPE Encapsulation of Nitinol Stents

Study Details

Brief summary:

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.

Conditions

Aneurysm

Study ID

NCT00549016

Start date

Nov, 2002

Status verified date

May, 2009

Completion date

Nov, 2012

Anticipated

Primary completion date

Nov, 2012

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1

Interventions

PTPE Encapsulation of Nitinol Stents

Both common femoral arteries (CFAs) are surgically exposed to allow bilateral access of diagnostic and therapeutic devices. The endoluminal stent graft is then deployed in accordance with the Instructions for Use.

Primary outcome measure

Technical success in the deployment and placement of the endoluminal graft to the aneurysmal site. [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Russell Williams

602-266-2200 rwilliams@azheart.com

Locations

Arizona Heart Institute

Recruiting

Phoenix, Arizona, United States, 85006

Principal Investigator:

Edward B Diethrich, M.D.

More Information

Sponsor

Arizona Heart Institute

Last update posted

May 15, 2009

Last verified

May, 2009

Keywords

Aneurysm Exclusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Arizona Heart Institute on 2009-05-15.