Clinical Study of Aneurysm Exclusion (Endologix)

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  Active, not recruiting
Sponsor:
Information provided by:
Arizona Heart Institute
ClinicalTrials.gov Identifier:
NCT00549380
First received: October 24, 2007
Last updated: May 25, 2010
Last verified: May 2009
  Purpose

The ultimate purpose is to explore potential techniques to exclude aneurysms and provide 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.


Condition Intervention Phase
Aneurysm
Device: Endologix, Inc. Endoluminal Technology
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Study of Aneurysm Exclusion Using Endologix, Inc. Endoluminal Technology

Resource links provided by NLM:


Further study details as provided by Arizona Heart Institute:

Primary Outcome Measures:
  • Feasibility applications [ Time Frame: Index procedure and discharge following index procedure ] [ Designated as safety issue: Yes ]
    The primary objective of this study is to examine the feasibility of expanded applications of the basic Endologix technology for the treatment of arterial aneurysmal disease.


Secondary Outcome Measures:
  • Data collection [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    A secondary objective of this study is to gather data in order to make logical, scientific recommendations for device design, construction, and application which will: a) expand the application of the endoluminal graft technology and b) improve its safety and efficacy while c) expanding the several potential future aspects of a less invasive method of treating arterial disease.


Estimated Enrollment: 88
Study Start Date: October 1999
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: Endologix, Inc. Endoluminal Technology
Stent-graft endoprosthesis is inserted by Delivery System via a surgical cutdown (e.g., external iliac artery, femoral artery, common iliac artery conduit, etc.) approach. The insertion method depends on each patient's anatomy and is determined by the Clinical Investigator.

Detailed Description:

The primary objective of this study is to examine the feasibility of expanded applications of the basic Endologix technology for the treatment of arterial aneurysmal disease. A second objective of this study is to gather data in order to make logical, scientific recommendations for device design, construction and application which will expand the application of the endoluminal graft technology and improve its safety and efficacy while expanding the several potential future positive aspects of a less invasive method of treating arterial occlusive disease.

Endologix, Inc. has applied for and received an IDE for the investigation of a bifurcated device to exclude aneurysms of the abdominal aorta. The Arizona Heart Institute experience indicates that this small study design will prove successful. Using the basic technology of the current approved IDE, it is Arizona Heart Institute's intention to expand the scope of application and design in order to address a greater population basis suffering from aneurysmal disease. In this regard, the basic Endologix device designs will be applied to appropriate patients beyond the scope of the current bifurcated IDE. Patients meeting the criteria for the Endologix IDE will be enrolled independently in that study and followed precisely in order to comply with the study design. Patients with aneurysmal disease not currently filling the criteria for a bifurcated abdominal aortic prosthetic but who could potentially benefit from the technology to exclude aneurysmal disease will be considered from this study.

The patient's participation in the Study will include enrollment, Investigational Device procedure and follow-up period. Patient data will be collected for 1, 6, and 12 months and beyond as indicated. Subject follow-up at 1 month will include; ABIs, a complete Physical Examination, Duplex Ultrasound, and X-ray. Subject follow-up at 6 and 12 months will also include ABIs, a complete Physical Examination, CT Scan-Contrast Enhanced (unless contraindicated), CT Scan-No Contrast, and X-ray.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 18 years old
  • Informed consent understood and signed.
  • Compliance with post-treatment follow-up requirements.
  • Candidates in this study may not be ideal surgical patients and therefore may be included based upon the recommendation of the principal investigator or co-investigators and one independent consultant confirming the opinion of the investigators.
  • Patient may present as an emergency or urgent use patient with indications including: ruptured aneurysm, dissected artery, or transected artery.

Exclusion Criteria:

  • Life expectancy < 2 years.
  • Pregnant or lactating women.
  • Indication that appropriate follow-up studies would for whatever reason be difficult to obtain.
  • Patient has other medical or psychiatric problems, which in the opinion of the investigator, precludes them from participating in the study.
  • Anticoagulation drugs are indicated.
  • Coagulopathy or bleeding disorder.
  • Active systemic or localized groin infection.
  • Inferior mesenteric artery is indispensable.
  • Creatinine level > 1.7 mg/dl.
  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: NCT00549380

Locations
United States, Arizona
Arizona Heart Institute
Phoenix, Arizona, United States, 85006
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: NCT00549380     History of Changes
Other Study ID Numbers: G990189
Study First Received: October 24, 2007
Last Updated: May 25, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Arizona Heart Institute:
Aneurysmal Disease in Thorax, Abdominal or Extremity

Additional relevant MeSH terms:
Aneurysm
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014