Clinical Study of Aneurysm Exclusion (EndoMed)
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|ClinicalTrials.gov Identifier: NCT00549016|
Recruitment Status : Unknown
Verified May 2009 by Arizona Heart Institute.
Recruitment status was: Recruiting
First Posted : October 25, 2007
Last Update Posted : May 15, 2009
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|Condition or disease||Intervention/treatment||Phase|
|Aneurysm||Device: PTPE Encapsulation of Nitinol Stents||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of Aneurysm Exclusion Using PTFE Encapsulation of Nitinol Stents|
|Study Start Date :||November 2002|
|Estimated Primary Completion Date :||November 2012|
|Estimated Study Completion Date :||November 2012|
Device: 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.
- Technical success in the deployment and placement of the endoluminal graft to the aneurysmal site. [ Time Frame: 1 month ]
- Acute success when the endoluminal graft excludes the aneurysm and maintain patency without endoleaks, migration or rupture. [ Time Frame: 1 month ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00549016
|Contact: Russell Williams||602-266-2200 ext email@example.com|
|United States, Arizona|
|Arizona Heart Institute||Recruiting|
|Phoenix, Arizona, United States, 85006|
|Principal Investigator: Edward B Diethrich, M.D.|
|Sub-Investigator: Julo Rodriguez-Lopez, M.D.|
|Sub-Investigator: Venkatesh Ramaiah, M.D.|
|Sub-Investigator: Rajagopalan Ravi, M.D.|
|Principal Investigator:||Edward B Diethrich, M.D.||Arizona Heart Institute|
|Responsible Party:||Edward B. Diethrich, MD, Arizona Heart Institute|
|Other Study ID Numbers:||
|First Posted:||October 25, 2007 Key Record Dates|
|Last Update Posted:||May 15, 2009|
|Last Verified:||May 2009|