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Sponsored by: |
Arizona Heart Institute |
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Information provided by: | Arizona Heart Institute |
ClinicalTrials.gov Identifier: | NCT00549380 |
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 |
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Aneurysm |
Device: Endologix, Inc. Endoluminal Technology |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Clinical Study of Aneurysm Exclusion Using Endologix, Inc. Endoluminal Technology |
Estimated Enrollment: | 88 |
Study Start Date: | October 1999 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Christopher DiMatteo, BS | 602-266-2200 ext 3624 | cdimatteo@azheart.com |
Contact: James Williams, BS | 602-266-2200 ext 3605 | jwilliams@azheart.com |
United States, Arizona | |
Arizona Heart Institute | Recruiting |
Phoenix, Arizona, United States, 85006 | |
Principal Investigator: Edward B Diethrich, M.D. | |
Sub-Investigator: Julio A Rodriguez-Lopez, M.D. | |
Sub-Investigator: Venkatesh Ramaiah, M.D. |
Principal Investigator: | Edward B Diethrich, M.D. | Arizona Heart Institute |
Responsible Party: | Arizona Heart Institute ( Edward B. Diethrich, MD ) |
Study ID Numbers: | G990189 |
Study First Received: | October 24, 2007 |
Last Updated: | May 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00549380 |
Health Authority: | United States: Food and Drug Administration |
Aneurysmal Disease in Thorax, Abdominal or Extremity |
Aneurysm Vascular Diseases |
Cardiovascular Diseases |