Clinical Study of Aneurysm Exclusion (EndoMed)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Arizona Heart Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Arizona Heart Institute
ClinicalTrials.gov Identifier:
NCT00549016
First received: October 24, 2007
Last updated: May 14, 2009
Last verified: May 2009
  Purpose

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 Intervention
Aneurysm
Device: PTPE Encapsulation of Nitinol Stents

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study of Aneurysm Exclusion Using PTFE Encapsulation of Nitinol Stents

Resource links provided by NLM:


Further study details as provided by Arizona Heart Institute:

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

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

Estimated Enrollment: 150
Study Start Date: November 2002
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549016

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

Locations
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
Investigators
Principal Investigator: Edward B Diethrich, M.D. Arizona Heart Institute
  More Information

No publications provided

Responsible Party: Edward B. Diethrich, MD, Arizona Heart Institute
ClinicalTrials.gov Identifier: NCT00549016     History of Changes
Other Study ID Numbers: G020035
Study First Received: October 24, 2007
Last Updated: May 14, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Arizona Heart Institute:
Aneurysm Exclusion

Additional relevant MeSH terms:
Aneurysm
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014