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| Sponsor: | Terumo CVS |
|---|---|
| Collaborator: |
Vascutek Ltd., Scotland |
| Information provided by: | Terumo CVS |
| ClinicalTrials.gov Identifier: | NCT00612924 |
Purpose
The Phase I safety study is now complete. FDA approval has been granted to proceed to Phase II. The primary objectives of the Phase II study is to assess the safety and effectiveness of the Anaconda Stent Graft System in subjects presenting with abdominal aortic aneurysm (AAA). The secondary objectives of this study are to assess additional clinical outcomes measurements associated with treatment of AAA using the Anaconda Stent Graft System
| Condition | Intervention | Phase |
|---|---|---|
|
Infrarenal Abdominal Aortic Aneurysm |
Device: Anaconda Stent Graft System |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | The Anaconda Endovascular Graft US FDA Phase II Clinical Study |
| Estimated Enrollment: | 180 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Anaconda: Experimental |
Device: Anaconda Stent Graft System
Endovascular device
|
Abdominal aortic aneurysms afflict a large number of patients in the United States and world-wide. The treatment of this disorder is based upon the concept of aneurysm repair prior to the presentation of symptoms or rupture. Thus aneurysm repair can be viewed as a prophylactic procedure embarked upon to prevent the disastrous complications of a ruptured aneurysm. The decision to treat an aneurysm electively is based upon a risk to benefit ratio. Treatment options include medical management of co-morbidities (hypertension, pulmonary disease, etc.) with observation of the aneurysm, open surgical aneurysm repair through a transabdominal or retroperitoneal approach, and endovascular aneurysm repair. The decision to intervene is based upon physician judgment. Once the decision to intervene is made, the mode of the intervention must be chosen. Although open surgical repair is more invasive and has been noted to have a higher morbidity and mortality(1;2) than most endovascular reports, and few argue with the effectiveness of the procedure. To date, open surgical repair remains the gold standard of care for the aneurysm patient. Endovascular repair has several beneficial characteristics in comparison to an open surgical approach. They include the potential for decreased need for blood transfusions, shorter intensive care unit and total hospital stays, the lack of endotracheal intubation, to name a few. However, the procedure requires adequate imaging prior to graft placement and during the follow-up period, in addition to the availability of a trained team to ensure proper device placement.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria;
Contacts and Locations| Contact: Tammy Burton | +1 2165707687 ext Cell | tammy.burton@terumomedical.com |
| Contact: Julie Lindsay | 949-293-0943 ext Cell | julie.lindsay@terumomedical.com |
Show 24 Study Locations| Study Director: | Tammy Burton | Vascutek, Terumo |
More Information
| Responsible Party: | Vascutek, Terumo CVS ( Tammy Burton ) |
| Study ID Numbers: | ANA-006, G030036 |
| Study First Received: | January 22, 2008 |
| Last Updated: | January 26, 2010 |
| ClinicalTrials.gov Identifier: | NCT00612924 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Aortic Diseases Aneurysm Aortic Aneurysm, Abdominal |
Vascular Diseases Cardiovascular Diseases Aortic Aneurysm |
