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Clinical Study of Aneurysm Exclusion (EndoMed)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Information provided by:
Arizona Heart Institute

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.

Condition or disease Intervention/treatment Phase
Aneurysm Device: PTPE Encapsulation of Nitinol Stents Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
Experimental: 1 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.

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

Secondary Outcome Measures :
  1. Acute success when the endoluminal graft excludes the aneurysm and maintain patency without endoleaks, migration or rupture. [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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

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Contact: Russell Williams 602-266-2200 ext 3604 rwilliams@azheart.com

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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.         
Sponsors and Collaborators
Arizona Heart Institute
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Principal Investigator: Edward B Diethrich, M.D. Arizona Heart Institute
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Responsible Party: Edward B. Diethrich, MD, Arizona Heart Institute
ClinicalTrials.gov Identifier: NCT00549016    
Other Study ID Numbers: G020035
First Posted: October 25, 2007    Key Record Dates
Last Update Posted: May 15, 2009
Last Verified: May 2009
Keywords provided by Arizona Heart Institute:
Aneurysm Exclusion
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases