Aortic Aneurysm, Abdominal
Conditions
Keywords
abdominal, aortic, aneurysm
Brief summary
The primary objectives of this study are to determine whether the Ovation Abdominal Stent Graft System is a safe and effective method of treating abdominal aortic aneurysms (AAA's) in those patients considered to be suitable candidates for open surgical repair.
Detailed description
This is a Phase II prospective, consecutive enrolling, non-randomized multi-center clinical evaluation of the safety and effectiveness of the Ovation Abdominal Stent Graft System when used in the treatment of patients with AAA (Treatment Group) as compared to a performance goal (Control Group). 150 study patients will be enrolled at up to 40 institutions. An additional 100 study patients will be enrolled in the continued access phase.
Interventions
DEVICEOvation™ Abdominal Stent Graft System
Implant of Ovation™ Abdominal Stent Graft System
Sponsors
TriVascular, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion/
Exclusion criteria
Inclusion Criteria All patients must meet all of the following inclusion criteria to be eligible for enrollment into this study: 1. Patient is \> 18 years of age 2. Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study) 3. Patient has signed an Institutional Review Board (IRB) approved Informed Consent Form 4. Patient is considered by the treating physician to be a candidate for elective open surgical repair of the abdominal aortic aneurysm (AAA) (i.e., category I, II, or III per American Society of Anesthesiology (ASA) classification. ASA category IV patients may be enrolled provided their life expectancy is greater than 1 year. 5. Patient has an infrarenal abdominal aortic aneurysm that meets at least one of the following: * Abdominal aortic aneurysm ≥5.0 cm in diameter * Aneurysm has increased in size by 0.5 cm in last 6 months. * Maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment 6. Patient has patent iliac or femoral arteries that allow endovascular access with the TriVascular Ovation Abdominal Stent Graft System. 7. Patient has a suitable non-aneurysmal proximal aortic neck length of ≥ 7 mm inferior to the most distal renal artery ostium. 8. Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥10 mm. The resultant repair should preserve patency in at least one hypogastric artery. 9. Patient has a suitable non-aneurysmal proximal aortic neck luminal diameter between 16 and 30 mm. 10. Patient has suitable non-aneurysmal distal iliac luminal diameters between 8 and 20 mm. 11. Patient meets the following anatomic criteria: the distance from the most distal renal artery to most superior internal iliac artery measurement is at least 13 cm. 12. Patient has juxtarenal aortic neck angulation ≤ 60º if proximal neck is ≥10 mm and ≤ 45º if proximal neck is \<10 mm. 13. Patient must be willing to comply with all required follow-up exams.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Safety Endpoint is Defined as the Percentage of Subjects Who Experience a Major Adverse Event Within 30 Days of the Initial Procedure. | 30 days | Major adverse events (MAE) are defined as any one of the following events: * Death * Myocardial Infarction * Stroke (excludes TIA) * Renal Failure (excludes renal insufficiency) * Respiratory Failure (excludes COPD or pulmonary complications) * Paralysis (excludes paraparesis) * Bowel Ischemia * Procedural Blood Loss (≥1,000 cc) |
| The Primary Effectiveness Endpoint is Percentage of Subjects That Achieve Treatment Success. | 1 year | Treatment Success is a composite endpoint assessed at 12 months that requires the following criteria to be met: * Technical Success, defined as successful delivery and deployment of one aortic body and two iliac limbs. * Freedom from Type I & III endoleaks at 12 months * Freedom from stent graft migration at 12 months * Freedom from abdominal aortic aneurysm (AAA) enlargement at 12 months * Freedom from abdominal aortic aneurysm (AAA) rupture and conversion to open repair through 12 months Endoleak Definition: Type I - Ineffective seal at either the proximal or distal sealing zones Type II - Retrograde blood flow from lumbar arteries, the inferior mesenteric artery, or other collateral vessels into the aneurysm sac Type III - A leak caused by fabric tears or disruption, component disconnection, or graft disintegration Type IV - Blood flow through an intact fabric. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ovation™ Abdominal Stent Graft System Implant of Ovation™ Abdominal Stent Graft System
Ovation™ Abdominal Stent Graft System: Implant of Ovation™ Abdominal Stent Graft System | 161 |
| Total | 161 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 12 Month | Death | 11 |
| 12 Month | Lost to Follow-up | 1 |
| 12 Month | Withdrawal by Subject | 2 |
| 1 Month | Death | 1 |
| 1 Month | Lost to Follow-up | 1 |
| 1 Month | Withdrawal by Subject | 1 |
| 6 Months | Death | 2 |
| 6 Months | Withdrawal by Subject | 3 |
| Index Procedure to 1 Month | Death | 1 |
| Year 2 | Death | 5 |
| Year 2 | Lost to Follow-up | 1 |
| Year 2 | Withdrawal by Subject | 4 |
| Year 3 | Death | 7 |
| Year 3 | Lost to Follow-up | 3 |
| Year 3 | Withdrawal by Subject | 9 |
| Year 4 | Death | 8 |
| Year 4 | Lost to Follow-up | 4 |
| Year 4 | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Ovation™ Abdominal Stent Graft System |
|---|---|
| Age, Continuous | 73 years STANDARD_DEVIATION 8 |
| American Society of Anesthesiology (ASA) Grade ASA Grade I | 9 Participants |
| American Society of Anesthesiology (ASA) Grade ASA Grade II | 45 Participants |
| American Society of Anesthesiology (ASA) Grade ASA Grade III | 96 Participants |
| American Society of Anesthesiology (ASA) Grade ASA Grade IV | 11 Participants |
| Aortic Aneurysm-Aortic aneurysm diameter | 53.6 mm STANDARD_DEVIATION 9 |
| Aortic aneurysm diameter distribution 40.0mm-49.9mm | 57 Participants |
| Aortic aneurysm diameter distribution 50.0mm-59.9mm | 81 Participants |
| Aortic aneurysm diameter distribution 60.0mm-69.9mm | 14 Participants |
| Aortic aneurysm diameter distribution 70.0mm-79.9mm | 5 Participants |
| Aortic aneurysm diameter distribution 80.0mm-89.9mm | 2 Participants |
| Aortic aneurysm diameter distribution 90.0mm-99.9mm | 2 Participants |
| Cardiovascular Disease Angina | 11 Participants |
| Cardiovascular Disease Arrhythmia | 35 Participants |
| Cardiovascular Disease Cardiomyopathy | 11 Participants |
| Cardiovascular Disease Congestive Heart Failure | 12 Participants |
| Cardiovascular Disease Coronary artery disease | 72 Participants |
| Cardiovascular Disease Hyperlipidemia | 113 Participants |
| Cardiovascular Disease Hypertension | 136 Participants |
| Cardiovascular Disease Hypotension | 1 Participants |
| Cardiovascular Disease Myocardial infarction | 33 Participants |
| Cardiovascular Disease Valvular heart disease | 19 Participants |
| Distal Aorta Aortic bifurcation diameter | 20.3 mm STANDARD_DEVIATION 6.9 |
| Distal Aorta Left iliac diameter | 13.7 mm STANDARD_DEVIATION 3.3 |
| Distal Aorta Left iliac minimum access diameter | 7.0 mm STANDARD_DEVIATION 1.6 |
| Distal Aorta Right iliac diameter | 13.9 mm STANDARD_DEVIATION 3 |
| Distal Aorta Right iliac minimum access diameter | 7.0 mm STANDARD_DEVIATION 1.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 144 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Gastrointestinal, Genitourinary, Reproductive History Alcohol abuse | 3 Participants |
| Gastrointestinal, Genitourinary, Reproductive History Diabetes | 34 Participants |
| Gastrointestinal, Genitourinary, Reproductive History Renal failure/insufficiency | 22 Participants |
| Hematological Problems (hemorrhage, coagulopathy disorder, anemia, platelet disorder) | 12 Participants |
| Other Significant Medical Condition | 122 Participants |
| Peripheral Vascular Disease, Stroke and Aneurysm History Carotid artery disease | 21 Participants |
| Peripheral Vascular Disease, Stroke and Aneurysm History Family History of aneurysms | 10 Participants |
| Peripheral Vascular Disease, Stroke and Aneurysm History Peripheral vascular disease | 38 Participants |
| Peripheral Vascular Disease, Stroke and Aneurysm History Stroke (CVA) | 13 Participants |
| Peripheral Vascular Disease, Stroke and Aneurysm History Transient ischemic attack | 8 Participants |
| Proximal Aorta Aortic diameter 13 mm distal to distal renal artery | 22.7 mm STANDARD_DEVIATION 3.1 |
| Proximal Aorta Aortic diameter 35 mm proximal to proximal renal artery | 25.0 mm STANDARD_DEVIATION 2.7 |
| Proximal Aorta Aortic diameter 7 mm distal to distal renal artery | 22.1 mm STANDARD_DEVIATION 2.9 |
| Proximal Aorta Aortic diameter at distal renal artery | 22.5 mm STANDARD_DEVIATION 2.7 |
| Proximal Aorta Proximal neck length | 23.0 mm STANDARD_DEVIATION 12.5 |
| Proximal Aorta-Juxtarenal angle | 19.1 Degrees STANDARD_DEVIATION 13.5 |
| Pulmonary History Chronic obstructive pulmonary disease (COPD) | 44 Participants |
| Pulmonary History Smoking | 113 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) White | 149 Participants |
| Region of Enrollment Chile | 20 participants |
| Region of Enrollment Germany | 30 participants |
| Region of Enrollment United States | 111 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 141 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 35 / 161 |
| other Total, other adverse events | 144 / 161 |
| serious Total, serious adverse events | 129 / 161 |
Outcome results
Primary
The Primary Effectiveness Endpoint is Percentage of Subjects That Achieve Treatment Success.
Treatment Success is a composite endpoint assessed at 12 months that requires the following criteria to be met: * Technical Success, defined as successful delivery and deployment of one aortic body and two iliac limbs. * Freedom from Type I & III endoleaks at 12 months * Freedom from stent graft migration at 12 months * Freedom from abdominal aortic aneurysm (AAA) enlargement at 12 months * Freedom from abdominal aortic aneurysm (AAA) rupture and conversion to open repair through 12 months Endoleak Definition: Type I - Ineffective seal at either the proximal or distal sealing zones Type II - Retrograde blood flow from lumbar arteries, the inferior mesenteric artery, or other collateral vessels into the aneurysm sac Type III - A leak caused by fabric tears or disruption, component disconnection, or graft disintegration Type IV - Blood flow through an intact fabric.
Time frame: 1 year
Population: 138 subjects completed study through 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ovation™ Abdominal Stent Graft System | The Primary Effectiveness Endpoint is Percentage of Subjects That Achieve Treatment Success. | 137 Participants |
Primary
The Primary Safety Endpoint is Defined as the Percentage of Subjects Who Experience a Major Adverse Event Within 30 Days of the Initial Procedure.
Major adverse events (MAE) are defined as any one of the following events: * Death * Myocardial Infarction * Stroke (excludes TIA) * Renal Failure (excludes renal insufficiency) * Respiratory Failure (excludes COPD or pulmonary complications) * Paralysis (excludes paraparesis) * Bowel Ischemia * Procedural Blood Loss (≥1,000 cc)
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ovation™ Abdominal Stent Graft System | The Primary Safety Endpoint is Defined as the Percentage of Subjects Who Experience a Major Adverse Event Within 30 Days of the Initial Procedure. | 4 Participants |