Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety of deploying and implanting the Altura Abdominal Aortic Aneurysm (AAA) Endograft in the treatment of abdominal aortic aneurysms in subjects who are candidates for open surgical aneurysm repair.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AAA Stent Graft System | Experimental | Altura Medical AAA Stent Graft System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Altura Medical Abdominal Aortic Aneurysm Stent-Graft | Device | Altura Medical AAA Stent Graft System |
|
| Measure | Description | Time Frame |
|---|---|---|
| The rate of major adverse events. | Adverse events defined as the composite endpoint of death, significant blood loss requiring intervention, respiratory failure, myocardial infarction, renal failure, paralysis, stroke, bowel ischemia and/or device migration causing vascular compromise. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of device defined by clinical and technical success | Evaluate the feasibility of using Altura AAA Endograft. Feasibility is comprised of acute clinical and technical success measured at the time of procedure. Long-term safety will be evaluated at 6 months, 1 year and 2 years. | 6 months, 1 year and 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Albrecht Kramer, MD | Pontificia Universidad Catolica de Chile | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pontificia Universidad Catolica De Chile | Santiago | 8330024 | Chile | |||
| Stradins University Hospital |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Riga |
| LV-1002 |
| Latvia |
| D001018 |
| Aortic Diseases |