Abdominal Aortic Aneurysm
Conditions
Keywords
Abdominal aortic aneurysm, Renal stent, Juxtarenal, Pararenal, Endovascular
Brief summary
The purpose of this trial is to determine if the Ventana Fenestrated Stent Graft System is safe and effective for the endovascular repair of juxtarenal or pararenal aortic aneurysms.
Detailed description
Study Objectives The objective of protocol CP-0004 is to study the safety and effectiveness of the Endologix Fenestrated System in the endovascular treatment of patients with juxtarenal and/or pararenal aortic aneurysms. Study Design This clinical study is a prospective, non-randomized, multicenter study. The first patient enrolled at each site is designated as a 'Roll-In' group patient. Subsequently, enrolled patients are designated as 'Trial' group patients for primary endpoint analysis. Primary Endpoint The primary safety endpoint is defined as the incidence of Major Adverse Events‡ (MAEs) within 30 days. The primary study effectiveness endpoint is Treatment Success at 1-year. This is defined as procedural technical success and the absence of aneurysm rupture; conversion to open surgical repair; Type I endoleak after 30 days; Type III endoleak; clinically significant migration; aneurysm enlargement; or secondary intervention for resolution of endoleak, limb occlusion, migration, aneurysm sac expansion and/or a device defect.
Interventions
The Ventana Fenestrated Stent Graft System consists of the following: bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts
Sponsors
Endologix
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
* Male or female at least 18 years old; * Informed consent understood and signed and patient agrees to all follow-up visits; * Have aortic aneurysm with maximum diameter ≥5.5cm, or between 4.5 and 5.5cm and rapidly expanding (\>0.5cm in six months), or \>50% larger than the normal aortic diameter * Anatomically eligible for the Bifurcated System per the FDA-approved indications for use (IFU) and for the Fenestrated Stent Graft System: * Adequate iliac/femoral access compatible with the required delivery systems * Non-aneurysmal infrarenal aortic neck \<15mm in length; * Most caudal renal artery to aortoiliac bifurcation length ≥70mm * SMA to aortoiliac bifurcation length ≥90mm; * Proximal non-aneurysmal aortic neck below the SMA with: diameter 18 to 34 mm; length ≥15 mm; angle ≤60° to the aneurysm sac; * Angle ≤60° (clock face) between the SMA and CA * Renal arteries both distal to the SMA by ≤35mm, within 30mm of each other axially, with 4 to 8mm lumen diameter, and with clock face angle of 90° to 210° to each other .Common iliac artery distal fixation site with: distal fixation length ≥15 mm; ability to preserve at least one hypogastric artery; diameter ≥10 mm and ≤23 mm; angle ≤90° to the aortic bifurcation. * The Endologix Fenestrated Proximal Extension Stent must have the ability to overlap the bifurcated stent graft by at least 3cm. * Aortic diameter at the most caudal renal artery of 18 to 36mm
Exclusion criteria
* Life expectancy \<2 years as judged by the investigator; * Psychiatric or other condition that may interfere with the study; * Participating in the enrollment or 30-day follow-up phase of another clinical study; * Known allergy to any device component; * Coagulopathy or uncontrolled bleeding disorder; * Contraindication to contrast media or anticoagulants; * Ruptured, leaking, or mycotic aneurysm; * Aortic dissection * Serum creatinine (S-Cr) level \>2.0 mg/dL; * Traumatic vascular injury; * Active systemic or localized groin infection; * Connective tissue disease (e.g., Marfan's Syndrome); * Recent (within prior three months) cerebrovascular accident or myocardial infarction; * Prior renal transplant; * Length of either renal artery to be stented \<13mm; * Significant occlusive disease of either renal artery (\>70% stenosis); * An essential accessory renal artery; * Indispensable inferior mesenteric artery; * Aneurysmal disease of the descending thoracic aorta; * Clinically significant mural thrombus circumferentially in the suprarenal segment; * Prior iliac artery stent implanted that may interfere with delivery system introduction; * Unsuitable vascular anatomy; * Pregnancy (female patient of childbearing potential only) * Existing renal stent; * Pre-planned need for concomitant procedure (e.g. surgical conduit for vascular access, hypogastric artery embolization/coil, renal artery angioplasty)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety- Number of Major Adverse Events at 30 Days | 30 Days | Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss \>1000cc |
| Effectiveness | 1 Year | 1. Treatment Success is defined as Procedural technical success and absence of aneurysm rupture, conversion to open repair, Type I endoleak after 30 days, Type III endoleak, clinically significant migration; aneurysm enlargement; or secondary intervention for resolution of endoleak, limb occlusion, migration, aneurysm sac expansion and/or a device defect. 2. Procedural Technical Success is defined as a subject with successful implant. 3. Clinically Significant Device Migration: Core Lab reported aortic stent graft movement \>10mm 4. Type I/III/IV Endoleak: Core Lab reported endoleak: between the endograft and the vessel either at the proximal attachment point (Type IA), or at the distal attachment point (Type IB), or between endograft components (Type III) or transgraft (Type IV). 5. Type II Endoleak: Core Lab reported endoleak emanating from a patent collateral vessel (e.g., inferior mesenteric artery, lumbar artery). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endoleaks | 30 Days to 5 Years | Endoleaks- Type IA, Type IB, Type II, Type IIIA, Type IIIB, Type IV, and Unknown Type Type I/III/IV Endoleak: Core Lab reported endoleak: between the endograft and the vessel either at the proximal attachment point (Type IA), or at the distal attachment point (Type IB), or between endograft components (Type III) or transgraft (Type IV). Type II Endoleak: Core Lab reported endoleak emanating from a patent collateral vessel (e.g., inferior mesenteric artery, lumbar artery). |
| Clinical Utility Outcomes | At the time of the procedure | Clinical Utility Outcomes consist of: fluoroscopy time, Bifurcated device placement time, Renal Artery Cannulation time, F-EVAR time and total procedure time. |
| Time in ICU | In-Hospital | Number of days spent in the intensive care unit (ICU) |
| Time to Hospital Discharge | Hospital Discharge (Post-Procedure) | Number of days from the index procedure to discharge from the hospital. |
| Safety- Number of Major Adverse Events > 30 Days to 5 Years | >30 Days to 5 Years | Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss \>1000cc |
| Device Integrity | 30 Days to 5 Years | Device Integrity- Device Migration, Ventana Stent Fracture, Left Renal Stent Fracture, Right Renal Stent Fracture, and Stent Kinking/ Compression |
| Aneurysm Sac Morphology | 30 Days to 5 Years | Aneurysm Sac Morphology- Aneurysm Shape, Aneurysm Enlargement |
| Aneurysm Sac Diameter | 30 Days to 5 Years | Aneurysm Sac diameter changes |
| Device Patency | 30 Days to 5 Years | Device patency- Ventana & Bifurcated Occlusion, Left Renal Artery Occlusion, and Right Renal Artery Occlusion |
| Renal Dysfunction | Discharge to 5 Years | Renal Dysfunction is calculated at greater than 30% reduction starting at baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ventana Fenestrated Stent Graft System Ventana Fenestrated Stent Graft System: The Ventana Fenestrated Stent Graft System consists of the following:
bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts | 76 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Conversion | 4 |
| Overall Study | Death | 30 |
| Overall Study | Missed Visit | 1 |
| Overall Study | Withdrwan/LTF | 16 |
Baseline characteristics
| Characteristic | Ventana Fenestrated Stent Graft System |
|---|---|
| Age, Continuous | 74.6 Years STANDARD_DEVIATION 8 |
| Aneurysm Diameter (mm) >=45-54 mm | 28 Participants |
| Aneurysm Diameter (mm) <45 mm | 1 Participants |
| Aneurysm Diameter (mm) >=55-64 mm | 33 Participants |
| Aneurysm Diameter (mm) >=65-74 mm | 12 Participants |
| Aneurysm Diameter (mm) >=75-84 mm | 1 Participants |
| Aneurysm Diameter (mm) >=85 mm | 1 Participants |
| Aneurysm Sac Diameter | 5.8 centimeter STANDARD_DEVIATION 0.8 |
| Aneurysm Shape Fusiform | 69 Participants |
| Aneurysm Shape Saccular | 7 Participants |
| Ankle Brachial Index ABI Left | 1.0 Ratio (percentage) STANDARD_DEVIATION 0.2 |
| Ankle Brachial Index ABI RIght | 1.0 Ratio (percentage) STANDARD_DEVIATION 0.2 |
| ASA Class ASA Class 1 | 1 Participants |
| ASA Class ASA Class 2 | 27 Participants |
| ASA Class ASA Class 3 | 38 Participants |
| ASA Class ASA Class 4 | 10 Participants |
| estimated Glomerular Filtration Rate (eGFR) | 77.9 mL/min/1.73m^2 STANDARD_DEVIATION 30.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 0 Participants |
| Race (NIH/OMB) White | 76 Participants |
| Region of Enrollment United States | 76 Participants |
| Serum Creatinine | 1.1 mg/dL STANDARD_DEVIATION 0.3 |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 30 / 76 |
| other Total, other adverse events | 71 / 76 |
| serious Total, serious adverse events | 50 / 76 |
Outcome results
Primary
Effectiveness
1. Treatment Success is defined as Procedural technical success and absence of aneurysm rupture, conversion to open repair, Type I endoleak after 30 days, Type III endoleak, clinically significant migration; aneurysm enlargement; or secondary intervention for resolution of endoleak, limb occlusion, migration, aneurysm sac expansion and/or a device defect. 2. Procedural Technical Success is defined as a subject with successful implant. 3. Clinically Significant Device Migration: Core Lab reported aortic stent graft movement \>10mm 4. Type I/III/IV Endoleak: Core Lab reported endoleak: between the endograft and the vessel either at the proximal attachment point (Type IA), or at the distal attachment point (Type IB), or between endograft components (Type III) or transgraft (Type IV). 5. Type II Endoleak: Core Lab reported endoleak emanating from a patent collateral vessel (e.g., inferior mesenteric artery, lumbar artery).
Time frame: 1 Year
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ventana Fenestrated Stent Graft System | Effectiveness | Aneurysm Rupture | 0 Participants |
| Ventana Fenestrated Stent Graft System | Effectiveness | Conversion to Open Repair | 1 Participants |
| Ventana Fenestrated Stent Graft System | Effectiveness | Secondary Interventions | 18 Participants |
| Ventana Fenestrated Stent Graft System | Effectiveness | Aneurysm Enlargement | 5 Participants |
| Ventana Fenestrated Stent Graft System | Effectiveness | Clinically Significant Migration | 0 Participants |
| Ventana Fenestrated Stent Graft System | Effectiveness | Type IA Endoleak | 0 Participants |
| Ventana Fenestrated Stent Graft System | Effectiveness | Type IB Endoleak | 1 Participants |
| Ventana Fenestrated Stent Graft System | Effectiveness | Type IIIA Endoleak | 2 Participants |
| Ventana Fenestrated Stent Graft System | Effectiveness | Type IIIB Endoleak | 2 Participants |
| Ventana Fenestrated Stent Graft System | Effectiveness | Procedural Technical Success | 74 Participants |
Primary
Safety- Number of Major Adverse Events at 30 Days
Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss \>1000cc
Time frame: 30 Days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ventana Fenestrated Stent Graft System | Safety- Number of Major Adverse Events at 30 Days | All Cause Death | 2 Events |
| Ventana Fenestrated Stent Graft System | Safety- Number of Major Adverse Events at 30 Days | Bowel Ischemia | 3 Events |
| Ventana Fenestrated Stent Graft System | Safety- Number of Major Adverse Events at 30 Days | Myocardial Infarction | 2 Events |
| Ventana Fenestrated Stent Graft System | Safety- Number of Major Adverse Events at 30 Days | Paraplegia | 1 Events |
| Ventana Fenestrated Stent Graft System | Safety- Number of Major Adverse Events at 30 Days | Procedural Blood Loss | 5 Events |
| Ventana Fenestrated Stent Graft System | Safety- Number of Major Adverse Events at 30 Days | Renal Failure 1 - Temporary/Permanent Hemodialysis | 4 Events |
| Ventana Fenestrated Stent Graft System | Safety- Number of Major Adverse Events at 30 Days | Renal Failure 2 - Serum Creatine >0.5mg/dL | 3 Events |
| Ventana Fenestrated Stent Graft System | Safety- Number of Major Adverse Events at 30 Days | Respiratory Failure 1 - Pneumonia | 1 Events |
| Ventana Fenestrated Stent Graft System | Safety- Number of Major Adverse Events at 30 Days | Respiratory Failure 2 - Ventilator >24hr | 2 Events |
| Ventana Fenestrated Stent Graft System | Safety- Number of Major Adverse Events at 30 Days | Stroke | 0 Events |
Secondary
Aneurysm Sac Diameter
Aneurysm Sac diameter changes
Time frame: 30 Days to 5 Years
Population: All available data has been reported
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ventana Fenestrated Stent Graft System | Aneurysm Sac Diameter | Aneurysm Sac Diameter Changes - Screening / Baseline | 58.4 mm | Standard Deviation 7.9 |
| Ventana Fenestrated Stent Graft System | Aneurysm Sac Diameter | Aneurysm Sac Diameter Changes - 1 month | 59.3 mm | Standard Deviation 7.6 |
| Ventana Fenestrated Stent Graft System | Aneurysm Sac Diameter | Aneurysm Sac Diameter Changes - 6 month | 57.6 mm | Standard Deviation 7.4 |
| Ventana Fenestrated Stent Graft System | Aneurysm Sac Diameter | Aneurysm Sac Diameter Changes - 1 year | 57.1 mm | Standard Deviation 8.3 |
| Ventana Fenestrated Stent Graft System | Aneurysm Sac Diameter | Aneurysm Sac Diameter Changes - 2 year | 56.7 mm | Standard Deviation 8.2 |
| Ventana Fenestrated Stent Graft System | Aneurysm Sac Diameter | Aneurysm Sac Diameter Changes - 3 year | 55.5 mm | Standard Deviation 8.8 |
| Ventana Fenestrated Stent Graft System | Aneurysm Sac Diameter | Aneurysm Sac Diameter Changes - 4 year | 56.9 mm | Standard Deviation 10.4 |
| Ventana Fenestrated Stent Graft System | Aneurysm Sac Diameter | Aneurysm Sac Diameter Changes - 5 year | 59.7 mm | Standard Deviation 13.4 |
Secondary
Aneurysm Sac Morphology
Aneurysm Sac Morphology- Aneurysm Shape, Aneurysm Enlargement
Time frame: 30 Days to 5 Years
Population: All available data has been reported
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ventana Fenestrated Stent Graft System | Aneurysm Sac Morphology | Aneurysm Shape- Fusiform | 69 Participants |
| Ventana Fenestrated Stent Graft System | Aneurysm Sac Morphology | Aneurysm Shape- Saccular | 7 Participants |
| Ventana Fenestrated Stent Graft System | Aneurysm Sac Morphology | Aneurysm Enlargement - 6 months | 1 Participants |
| Ventana Fenestrated Stent Graft System | Aneurysm Sac Morphology | Aneurysm Enlargement - 1 year | 4 Participants |
| Ventana Fenestrated Stent Graft System | Aneurysm Sac Morphology | Aneurysm Enlargement - 2 year | 8 Participants |
| Ventana Fenestrated Stent Graft System | Aneurysm Sac Morphology | Aneurysm Enlargement - 3 year | 8 Participants |
| Ventana Fenestrated Stent Graft System | Aneurysm Sac Morphology | Aneurysm Enlargement - 4 year | 6 Participants |
| Ventana Fenestrated Stent Graft System | Aneurysm Sac Morphology | Aneurysm Enlargement - 5 year | 6 Participants |
Secondary
Clinical Utility Outcomes
Clinical Utility Outcomes consists of: contrast volume and estimated blood loss.
Time frame: At the time of the procedure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ventana Fenestrated Stent Graft System | Clinical Utility Outcomes | Contrast Volume | 132 mL | Standard Deviation 64 |
| Ventana Fenestrated Stent Graft System | Clinical Utility Outcomes | Blood loss | 401 mL | Standard Deviation 513 |
Secondary
Clinical Utility Outcomes
Clinical Utility Outcomes consist of: fluoroscopy time, Bifurcated device placement time, Renal Artery Cannulation time, F-EVAR time and total procedure time.
Time frame: At the time of the procedure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ventana Fenestrated Stent Graft System | Clinical Utility Outcomes | Fluoroscopy Time | 58 Mins | Standard Deviation 33 |
| Ventana Fenestrated Stent Graft System | Clinical Utility Outcomes | Bifurcated Device Placement Time | 56 Mins | Standard Deviation 24 |
| Ventana Fenestrated Stent Graft System | Clinical Utility Outcomes | Renal Artery Cannulation Time | 35 Mins | Standard Deviation 45 |
| Ventana Fenestrated Stent Graft System | Clinical Utility Outcomes | F-EVAR Time | 68 Mins | Standard Deviation 32 |
| Ventana Fenestrated Stent Graft System | Clinical Utility Outcomes | Total Procedure Time | 205 Mins | Standard Deviation 84 |
Secondary
Device Integrity
Device Integrity- Device Migration, Ventana Stent Fracture, Left Renal Stent Fracture, Right Renal Stent Fracture, and Stent Kinking/ Compression
Time frame: 30 Days to 5 Years
Population: All available data at various timepoints has been reported
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ventana Fenestrated Stent Graft System | Device Integrity | Device Migration- 6 Month | 0 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Device Migration- 1 year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Device Migration- 2 year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Device Migration- 3 year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Device Migration- 4 year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Device Migration- 5 year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Ventana Stent Fracture- 1 Month | 1 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Left Renal Stent Fracture- 1 Month | 1 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Right Renal Stent Fracture- 1 Month | 0 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Stent Kinking/ Compression- 1 Month | 0 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Ventana Stent Fracture- 6 Month | 3 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Left Renal Stent Fracture- 6 Month | 2 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Right Renal Stent Fracture- 6 Month | 0 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Stent Kinking/ Compression- 6 Month | 0 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Ventana Stent Fracture- 1 Year | 7 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Left Renal Stent Fracture- 1 Year | 7 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Right Renal Stent Fracture- 1 Year | 1 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Stent Kinking/ Compression- 1 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Ventana Stent Fracture- 2 Year | 12 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Left Renal Stent Fracture- 2 Year | 8 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Right Renal Stent Fracture- 2 Year | 2 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Stent Kinking/ Compression- 2 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Ventana Stent Fracture- 3 Year | 10 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Left Renal Stent Fracture- 3 Year | 5 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Right Renal Stent Fracture- 3 Year | 3 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Stent Kinking/ Compression- 3 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Ventana Stent Fracture- 4 Year | 13 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Left Renal Stent Fracture- 4 Year | 3 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Right Renal Stent Fracture- 4 Year | 4 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Stent Kinking/ Compression- 4 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Ventana Stent Fracture- 5 Year | 11 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Left Renal Stent Fracture- 5 Year | 3 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Right Renal Stent Fracture- 5 Year | 2 Participants |
| Ventana Fenestrated Stent Graft System | Device Integrity | Stent Kinking/ Compression- 5 Year | 0 Participants |
Secondary
Device Patency
Device patency- Ventana & Bifurcated Occlusion, Left Renal Artery Occlusion, and Right Renal Artery Occlusion
Time frame: 30 Days to 5 Years
Population: All available data at various timepoints have been reported
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ventana Fenestrated Stent Graft System | Device Patency | Ventana & Bifurcated Occlusion - 1 Month | 0 Participants |
| Ventana Fenestrated Stent Graft System | Device Patency | Left Renal Artery Occlusion - 1 month | 2 Participants |
| Ventana Fenestrated Stent Graft System | Device Patency | Right Renal Artery Occlusion - 1month | 3 Participants |
| Ventana Fenestrated Stent Graft System | Device Patency | Ventana & Bifurcated Occlusion- 6 Month | 0 Participants |
| Ventana Fenestrated Stent Graft System | Device Patency | Left Renal Artery Occlusion- 6 Month | 2 Participants |
| Ventana Fenestrated Stent Graft System | Device Patency | Right Renal Artery Occlusion- 6 Month | 2 Participants |
| Ventana Fenestrated Stent Graft System | Device Patency | Ventana & Bifurcated Occlusion- 1 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Device Patency | Left Renal Artery Occlusion- 1 Year | 2 Participants |
| Ventana Fenestrated Stent Graft System | Device Patency | Right Renal Artery Occlusion- 1 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Device Patency | Ventana & Bifurcated Occlusion- 2 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Device Patency | Left Renal Artery Occlusion- 2 Year | 1 Participants |
| Ventana Fenestrated Stent Graft System | Device Patency | Right Renal Artery Occlusion- 2 Year | 1 Participants |
| Ventana Fenestrated Stent Graft System | Device Patency | Ventana & Bifurcated Occlusion- 3 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Device Patency | Left Renal Artery Occlusion- 3 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Device Patency | Right Renal Artery Occlusion- 3 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Device Patency | Ventana & Bifurcated Occlusion - 4 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Device Patency | Left Renal Artery Occlusion- 4 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Device Patency | Right Renal Artery Occlusion- 4 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Device Patency | Ventana & Bifurcated Occlusion- 5 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Device Patency | Left Renal Artery Occlusion- 5 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Device Patency | Right Renal Artery Occlusion- 5 Year | 0 Participants |
Secondary
Endoleaks
Endoleaks- Type IA, Type IB, Type II, Type IIIA, Type IIIB, Type IV, and Unknown Type Type I/III/IV Endoleak: Core Lab reported endoleak: between the endograft and the vessel either at the proximal attachment point (Type IA), or at the distal attachment point (Type IB), or between endograft components (Type III) or transgraft (Type IV). Type II Endoleak: Core Lab reported endoleak emanating from a patent collateral vessel (e.g., inferior mesenteric artery, lumbar artery).
Time frame: 30 Days to 5 Years
Population: All available data based on different timepoints has been reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IA- 1 month | 0 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IB- 1 Month | 0 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type II - 1 month | 11 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IIIA- 1 month | 0 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IIIB - 1 month | 0 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IV - 1 month | 0 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Unknown Type - 1 month | 6 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IA - 6 month | 0 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IB- 6 Month | 0 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type II- 6 Month | 9 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IIIA- 6 Month | 0 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IIIB- 6 Month | 0 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IV- 6 Month | 0 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Unknown Type- 6 Month | 5 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IA- 1 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IB -1 Year | 1 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type II -1 Year | 6 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IIIA- 1 Year | 2 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IIIB- 1 Year | 2 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IV - 1 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Unknown Type- 1 Year | 4 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IA- 2 year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IB- 2 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type II- 2 Year | 6 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IIIA- 2 Year | 2 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IIIB- 2 Year | 3 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IV- 2 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Unknown Type- 2 Year | 4 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IA- 3 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IB- 3 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type II- 3 Year | 5 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IIIA- 3 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IIIB- 3 Year | 1 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IV- 3 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Unknown Type- 3 Year | 2 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IA- 4 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IB- 4 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type II- 4 Year | 4 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IIIA- 4 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IIIB- 4 Year | 2 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IV- 4 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Unknown Type- 4 Year | 3 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IA- 5 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IB- 5 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type II- 5 Year | 1 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IIIA- 5 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IIIB- 5 Year | 1 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Type IV- 5 Year | 0 Participants |
| Ventana Fenestrated Stent Graft System | Endoleaks | Unknown Type- 5 Year | 2 Participants |
Secondary
Renal Dysfunction
Renal Dysfunction is calculated at greater than 30% reduction starting at baseline
Time frame: Discharge to 5 Years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ventana Fenestrated Stent Graft System | Renal Dysfunction | 1-Month Follow-up | 9 Participants |
| Ventana Fenestrated Stent Graft System | Renal Dysfunction | 6-Month Follow-up | 11 Participants |
| Ventana Fenestrated Stent Graft System | Renal Dysfunction | 1-Year Follow-up | 22 Participants |
| Ventana Fenestrated Stent Graft System | Renal Dysfunction | 2-Year Follow-up | 16 Participants |
| Ventana Fenestrated Stent Graft System | Renal Dysfunction | 3-Year Follow-up | 11 Participants |
| Ventana Fenestrated Stent Graft System | Renal Dysfunction | 4-Year Follow-up | 11 Participants |
| Ventana Fenestrated Stent Graft System | Renal Dysfunction | 5-Year Follow-up | 8 Participants |
Secondary
Safety- Number of Major Adverse Events > 30 Days to 5 Years
Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss \>1000cc
Time frame: >30 Days to 5 Years
Population: All available data has been reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ventana Fenestrated Stent Graft System | Safety- Number of Major Adverse Events > 30 Days to 5 Years | All Cause Death | 28 Number of events |
| Ventana Fenestrated Stent Graft System | Safety- Number of Major Adverse Events > 30 Days to 5 Years | Bowel Ischemia | 2 Number of events |
| Ventana Fenestrated Stent Graft System | Safety- Number of Major Adverse Events > 30 Days to 5 Years | Myocardial Infarction | 3 Number of events |
| Ventana Fenestrated Stent Graft System | Safety- Number of Major Adverse Events > 30 Days to 5 Years | Paraplegia | 0 Number of events |
| Ventana Fenestrated Stent Graft System | Safety- Number of Major Adverse Events > 30 Days to 5 Years | Procedural Blood Loss | 0 Number of events |
| Ventana Fenestrated Stent Graft System | Safety- Number of Major Adverse Events > 30 Days to 5 Years | Renal Failure 1 - Temporary/Permanent Hemodialysis | 10 Number of events |
| Ventana Fenestrated Stent Graft System | Safety- Number of Major Adverse Events > 30 Days to 5 Years | Renal Failure 2 - Serum Creatinine >0.5mg/dL rise | 2 Number of events |
| Ventana Fenestrated Stent Graft System | Safety- Number of Major Adverse Events > 30 Days to 5 Years | Respiratory Failure 1 - Pneumonia | 9 Number of events |
| Ventana Fenestrated Stent Graft System | Safety- Number of Major Adverse Events > 30 Days to 5 Years | Respiratory Failure 2 - Ventilator >24 Hours | 3 Number of events |
| Ventana Fenestrated Stent Graft System | Safety- Number of Major Adverse Events > 30 Days to 5 Years | Stroke | 6 Number of events |
Secondary
Time in ICU
Number of days spent in the intensive care unit (ICU)
Time frame: In-Hospital
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ventana Fenestrated Stent Graft System | Time in ICU | 3 Days | Standard Deviation 11 |
Secondary
Time to Hospital Discharge
Number of days from the index procedure to discharge from the hospital.
Time frame: Hospital Discharge (Post-Procedure)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ventana Fenestrated Stent Graft System | Time to Hospital Discharge | 4 Days | Standard Deviation 8 |