Aneurysm Clinical Trial
— EndologixOfficial title:
A Clinical Study of Aneurysm Exclusion Using Endologix, Inc. Endoluminal Technology
Verified date | May 2009 |
Source | Arizona Heart Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 88 |
Est. completion date | October 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Arizona Heart Institute | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Arizona Heart Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility applications | 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. | Index procedure and discharge following index procedure | Yes |
Secondary | Data collection | 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. | 1 month | No |
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