Safety and Effectiveness Trial of the Ventana Fenestrated Stent Graft System
Sponsor
Endologix (Industry)
Overall Status
Completed
CT.gov ID
NCT01491945
Collaborator
(none)
76
22
1
65
3.5
0.1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
76 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective, Multicenter, Single Arm Safety and Effectiveness Trial of the Endologix Fenestrated Stent Graft System for the Endovascular Repair of Juxtarenal/Pararenal (JAA/PAA) Aneurysms
Actual Study Start Date
:
Mar 3, 2013
Actual Primary Completion Date
:
Apr 1, 2017
Actual Study Completion Date
:
Aug 1, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ventana Fenestrated Stent Graft System Ventana Fenestrated Stent Graft System |
Device: 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
|
Outcome Measures
Primary Outcome Measures
- 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]
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. Procedural Technical Success is defined as a subject with successful implant. Clinically Significant Device Migration: Core Lab reported aortic stent graft movement >10mm 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).
Secondary Outcome Measures
- 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
- Renal Dysfunction [Discharge to 5 Years]
Renal Dysfunction is calculated at greater than 30% reduction starting at baseline
- 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.
- Device Patency [30 Days to 5 Years]
Device patency- Ventana & Bifurcated Occlusion, Left Renal Artery Occlusion, and Right Renal Artery Occlusion
- 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
- Clinical Utility Outcomes [At the time of the procedure]
Clinical Utility Outcomes consists of: contrast volume and estimated blood loss.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts 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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35429 |
| 2 | Arizona Heart Institute | Phoenix | Arizona | United States | 85016 |
| 3 | John Muir Medical Center Concord, CA | Concord | California | United States | 94520 |
| 4 | UCLA Medical Center | Los Angeles | California | United States | 90095 |
| 5 | VA Gainesville | Gainesville | Florida | United States | 32608 |
| 6 | Emory University | Atlanta | Georgia | United States | 30322 |
| 7 | Indiana University | Indianapolis | Indiana | United States | 46202 |
| 8 | Baptist East Hospital | Louisville | Kentucky | United States | 40207 |
| 9 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 10 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
| 11 | William Beaumont Hospital | Royal Oak | Michigan | United States | 48073 |
| 12 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 13 | Barnes-Jewish Hospital | Saint Louis | Missouri | United States | 63110 |
| 14 | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 15 | University of North Carolina | Chapel Hill | North Carolina | United States | 27599 |
| 16 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 17 | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 18 | UPMC | Pittsburgh | Pennsylvania | United States | 15232 |
| 19 | Methodist Hospital | Houston | Texas | United States | 77030 |
| 20 | Harborview Medical Center | Seattle | Washington | United States | 98104 |
| 21 | Charleston Area Medical Center | Charleston | West Virginia | United States | 25304 |
| 22 | Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | United States | 53215 |
Sponsors and Collaborators
- Endologix
Investigators
- Principal Investigator: Daniel G Clair, MD, The Cleveland Clinic
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Endologix
ClinicalTrials.gov Identifier:
NCT01491945
Other Study ID Numbers:
- CP-0004
First Posted:
Dec 14, 2011
Last Update Posted:
Oct 15, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Endologix
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Ventana Fenestrated Stent Graft System |
|---|---|
| Arm/Group Description | Objective is to study the safety and effectiveness of the Endologix Fenestrated Stent Graft System in the endovascular treatment of patients with juxtarenal and/or pararenal aortic aneurysms. Subjects were treated with the Ventana Fenestrated system in this arm and The Ventana Fenestrated Stent Graft System consisted of the following: bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts. |
| Period Title: Overall Study | |
| STARTED | 76 |
| COMPLETED | 25 |
| NOT COMPLETED | 51 |
Baseline Characteristics
| Arm/Group Title | Ventana Fenestrated Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Overall Participants | 76 |
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
74.6
(8.0)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
17
22.4%
|
| Male |
59
77.6%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
76
100%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (Count of Participants) | |
| United States |
76
100%
|
| Serum Creatinine (mg/dL) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [mg/dL] |
1.1
(0.3)
|
| ASA Class (Count of Participants) | |
| ASA Class 1 |
1
1.3%
|
| ASA Class 2 |
27
35.5%
|
| ASA Class 3 |
38
50%
|
| ASA Class 4 |
10
13.2%
|
| estimated Glomerular Filtration Rate (eGFR) (mL/min/1.73m^2) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [mL/min/1.73m^2] |
77.9
(30.1)
|
| Ankle Brachial Index (Ratio (percentage)) [Mean (Standard Deviation) ] | |
| ABI Left |
1.0
(0.2)
|
| ABI RIght |
1.0
(0.2)
|
| Aneurysm Shape (Count of Participants) | |
| Fusiform |
69
90.8%
|
| Saccular |
7
9.2%
|
| Aneurysm Sac Diameter (centimeter) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [centimeter] |
5.8
(0.8)
|
| Aneurysm Diameter (mm) (Count of Participants) | |
| <45 mm |
1
1.3%
|
| >=45-54 mm |
28
36.8%
|
| >=55-64 mm |
33
43.4%
|
| >=65-74 mm |
12
15.8%
|
| >=75-84 mm |
1
1.3%
|
| >=85 mm |
1
1.3%
|
Outcome Measures
| Title | Safety- Number of Major Adverse Events at 30 Days |
|---|---|
| Description | Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss >1000cc |
| Time Frame | 30 Days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ventana Fenestrated Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 76 |
| All Cause Death |
2
|
| Bowel Ischemia |
3
|
| Myocardial Infarction |
2
|
| Paraplegia |
1
|
| Procedural Blood Loss |
5
|
| Renal Failure 1 - Temporary/Permanent Hemodialysis |
4
|
| Renal Failure 2 - Serum Creatine >0.5mg/dL |
3
|
| Respiratory Failure 1 - Pneumonia |
1
|
| Respiratory Failure 2 - Ventilator >24hr |
2
|
| Stroke |
0
|
| Title | Effectiveness |
|---|---|
| Description | 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. Procedural Technical Success is defined as a subject with successful implant. Clinically Significant Device Migration: Core Lab reported aortic stent graft movement >10mm 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 | 1 Year |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ventana Fenestrated Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 76 |
| Aneurysm Rupture |
0
0%
|
| Conversion to Open Repair |
1
1.3%
|
| Secondary Interventions |
18
23.7%
|
| Aneurysm Enlargement |
5
6.6%
|
| Clinically Significant Migration |
0
0%
|
| Type IA Endoleak |
0
0%
|
| Type IB Endoleak |
1
1.3%
|
| Type IIIA Endoleak |
2
2.6%
|
| Type IIIB Endoleak |
2
2.6%
|
| Procedural Technical Success |
74
97.4%
|
| Title | Safety- Number of Major Adverse Events > 30 Days to 5 Years |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All available data has been reported. |
| Arm/Group Title | Ventana Fenestrated Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 74 |
| All Cause Death |
28
|
| Bowel Ischemia |
2
|
| Myocardial Infarction |
3
|
| Paraplegia |
0
|
| Procedural Blood Loss |
0
|
| Renal Failure 1 - Temporary/Permanent Hemodialysis |
10
|
| Renal Failure 2 - Serum Creatinine >0.5mg/dL rise |
2
|
| Respiratory Failure 1 - Pneumonia |
9
|
| Respiratory Failure 2 - Ventilator >24 Hours |
3
|
| Stroke |
6
|
| Title | Renal Dysfunction |
|---|---|
| Description | Renal Dysfunction is calculated at greater than 30% reduction starting at baseline |
| Time Frame | Discharge to 5 Years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ventana Fenestrated Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 76 |
| 1-Month Follow-up |
9
11.8%
|
| 6-Month Follow-up |
11
14.5%
|
| 1-Year Follow-up |
22
28.9%
|
| 2-Year Follow-up |
16
21.1%
|
| 3-Year Follow-up |
11
14.5%
|
| 4-Year Follow-up |
11
14.5%
|
| 5-Year Follow-up |
8
10.5%
|
| Title | Endoleaks |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All available data based on different timepoints has been reported. |
| Arm/Group Title | Ventana Fenestrated Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 69 |
| Type IA- 1 month |
0
0%
|
| Type IB- 1 Month |
0
0%
|
| Type II - 1 month |
11
14.5%
|
| Type IIIA- 1 month |
0
0%
|
| Type IIIB - 1 month |
0
0%
|
| Type IV - 1 month |
0
0%
|
| Unknown Type - 1 month |
6
7.9%
|
| Type IA - 6 month |
0
0%
|
| Type IB- 6 Month |
0
0%
|
| Type II- 6 Month |
9
11.8%
|
| Type IIIA- 6 Month |
0
0%
|
| Type IIIB- 6 Month |
0
0%
|
| Type IV- 6 Month |
0
0%
|
| Unknown Type- 6 Month |
5
6.6%
|
| Type IA- 1 Year |
0
0%
|
| Type IB -1 Year |
1
1.3%
|
| Type II -1 Year |
6
7.9%
|
| Type IIIA- 1 Year |
2
2.6%
|
| Type IIIB- 1 Year |
2
2.6%
|
| Type IV - 1 Year |
0
0%
|
| Unknown Type- 1 Year |
4
5.3%
|
| Type IA- 2 year |
0
0%
|
| Type IB- 2 Year |
0
0%
|
| Type II- 2 Year |
6
7.9%
|
| Type IIIA- 2 Year |
2
2.6%
|
| Type IIIB- 2 Year |
3
3.9%
|
| Type IV- 2 Year |
0
0%
|
| Unknown Type- 2 Year |
4
5.3%
|
| Type IA- 3 Year |
0
0%
|
| Type IB- 3 Year |
0
0%
|
| Type II- 3 Year |
5
6.6%
|
| Type IIIA- 3 Year |
0
0%
|
| Type IIIB- 3 Year |
1
1.3%
|
| Type IV- 3 Year |
0
0%
|
| Unknown Type- 3 Year |
2
2.6%
|
| Type IA- 4 Year |
0
0%
|
| Type IB- 4 Year |
0
0%
|
| Type II- 4 Year |
4
5.3%
|
| Type IIIA- 4 Year |
0
0%
|
| Type IIIB- 4 Year |
2
2.6%
|
| Type IV- 4 Year |
0
0%
|
| Unknown Type- 4 Year |
3
3.9%
|
| Type IA- 5 Year |
0
0%
|
| Type IB- 5 Year |
0
0%
|
| Type II- 5 Year |
1
1.3%
|
| Type IIIA- 5 Year |
0
0%
|
| Type IIIB- 5 Year |
1
1.3%
|
| Type IV- 5 Year |
0
0%
|
| Unknown Type- 5 Year |
2
2.6%
|
| Title | Clinical Utility Outcomes |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ventana Fenestrated Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 76 |
| Fluoroscopy Time |
58
(33)
|
| Bifurcated Device Placement Time |
56
(24)
|
| Renal Artery Cannulation Time |
35
(45)
|
| F-EVAR Time |
68
(32)
|
| Total Procedure Time |
205
(84)
|
| Title | Time in ICU |
|---|---|
| Description | Number of days spent in the intensive care unit (ICU) |
| Time Frame | In-Hospital |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ventana Fenestrated Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 76 |
| Mean (Standard Deviation) [Days] |
3
(11)
|
| Title | Time to Hospital Discharge |
|---|---|
| Description | Number of days from the index procedure to discharge from the hospital. |
| Time Frame | Hospital Discharge (Post-Procedure) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ventana Fenestrated Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 76 |
| Mean (Standard Deviation) [Days] |
4
(8)
|
| Title | Device Patency |
|---|---|
| Description | Device patency- Ventana & Bifurcated Occlusion, Left Renal Artery Occlusion, and Right Renal Artery Occlusion |
| Time Frame | 30 Days to 5 Years |
Outcome Measure Data
| Analysis Population Description |
|---|
| All available data at various timepoints have been reported |
| Arm/Group Title | Ventana Fenestrated Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 69 |
| Ventana & Bifurcated Occlusion - 1 Month |
0
0%
|
| Left Renal Artery Occlusion - 1 month |
2
2.6%
|
| Right Renal Artery Occlusion - 1month |
3
3.9%
|
| Ventana & Bifurcated Occlusion- 6 Month |
0
0%
|
| Left Renal Artery Occlusion- 6 Month |
2
2.6%
|
| Right Renal Artery Occlusion- 6 Month |
2
2.6%
|
| Ventana & Bifurcated Occlusion- 1 Year |
0
0%
|
| Left Renal Artery Occlusion- 1 Year |
2
2.6%
|
| Right Renal Artery Occlusion- 1 Year |
0
0%
|
| Ventana & Bifurcated Occlusion- 2 Year |
0
0%
|
| Left Renal Artery Occlusion- 2 Year |
1
1.3%
|
| Right Renal Artery Occlusion- 2 Year |
1
1.3%
|
| Ventana & Bifurcated Occlusion- 3 Year |
0
0%
|
| Left Renal Artery Occlusion- 3 Year |
0
0%
|
| Right Renal Artery Occlusion- 3 Year |
0
0%
|
| Ventana & Bifurcated Occlusion - 4 Year |
0
0%
|
| Left Renal Artery Occlusion- 4 Year |
0
0%
|
| Right Renal Artery Occlusion- 4 Year |
0
0%
|
| Ventana & Bifurcated Occlusion- 5 Year |
0
0%
|
| Left Renal Artery Occlusion- 5 Year |
0
0%
|
| Right Renal Artery Occlusion- 5 Year |
0
0%
|
| Title | Device Integrity |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All available data at various timepoints has been reported |
| Arm/Group Title | Ventana Fenestrated Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 73 |
| Device Migration- 6 Month |
0
0%
|
| Device Migration- 1 year |
0
0%
|
| Device Migration- 2 year |
0
0%
|
| Device Migration- 3 year |
0
0%
|
| Device Migration- 4 year |
0
0%
|
| Device Migration- 5 year |
0
0%
|
| Ventana Stent Fracture- 1 Month |
1
1.3%
|
| Left Renal Stent Fracture- 1 Month |
1
1.3%
|
| Right Renal Stent Fracture- 1 Month |
0
0%
|
| Stent Kinking/ Compression- 1 Month |
0
0%
|
| Ventana Stent Fracture- 6 Month |
3
3.9%
|
| Left Renal Stent Fracture- 6 Month |
2
2.6%
|
| Right Renal Stent Fracture- 6 Month |
0
0%
|
| Stent Kinking/ Compression- 6 Month |
0
0%
|
| Ventana Stent Fracture- 1 Year |
7
9.2%
|
| Left Renal Stent Fracture- 1 Year |
7
9.2%
|
| Right Renal Stent Fracture- 1 Year |
1
1.3%
|
| Stent Kinking/ Compression- 1 Year |
0
0%
|
| Ventana Stent Fracture- 2 Year |
12
15.8%
|
| Left Renal Stent Fracture- 2 Year |
8
10.5%
|
| Right Renal Stent Fracture- 2 Year |
2
2.6%
|
| Stent Kinking/ Compression- 2 Year |
0
0%
|
| Ventana Stent Fracture- 3 Year |
10
13.2%
|
| Left Renal Stent Fracture- 3 Year |
5
6.6%
|
| Right Renal Stent Fracture- 3 Year |
3
3.9%
|
| Stent Kinking/ Compression- 3 Year |
0
0%
|
| Ventana Stent Fracture- 4 Year |
13
17.1%
|
| Left Renal Stent Fracture- 4 Year |
3
3.9%
|
| Right Renal Stent Fracture- 4 Year |
4
5.3%
|
| Stent Kinking/ Compression- 4 Year |
0
0%
|
| Ventana Stent Fracture- 5 Year |
11
14.5%
|
| Left Renal Stent Fracture- 5 Year |
3
3.9%
|
| Right Renal Stent Fracture- 5 Year |
2
2.6%
|
| Stent Kinking/ Compression- 5 Year |
0
0%
|
| Title | Aneurysm Sac Morphology |
|---|---|
| Description | Aneurysm Sac Morphology- Aneurysm Shape, Aneurysm Enlargement |
| Time Frame | 30 Days to 5 Years |
Outcome Measure Data
| Analysis Population Description |
|---|
| All available data has been reported |
| Arm/Group Title | Ventana Fenestrated Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 76 |
| Aneurysm Shape- Fusiform |
69
90.8%
|
| Aneurysm Shape- Saccular |
7
9.2%
|
| Aneurysm Enlargement - 6 months |
1
1.3%
|
| Aneurysm Enlargement - 1 year |
4
5.3%
|
| Aneurysm Enlargement - 2 year |
8
10.5%
|
| Aneurysm Enlargement - 3 year |
8
10.5%
|
| Aneurysm Enlargement - 4 year |
6
7.9%
|
| Aneurysm Enlargement - 5 year |
6
7.9%
|
| Title | Aneurysm Sac Diameter |
|---|---|
| Description | Aneurysm Sac diameter changes |
| Time Frame | 30 Days to 5 Years |
Outcome Measure Data
| Analysis Population Description |
|---|
| All available data has been reported |
| Arm/Group Title | Ventana Fenestrated Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 76 |
| Aneurysm Sac Diameter Changes - Screening / Baseline |
58.4
(7.9)
|
| Aneurysm Sac Diameter Changes - 1 month |
59.3
(7.6)
|
| Aneurysm Sac Diameter Changes - 6 month |
57.6
(7.4)
|
| Aneurysm Sac Diameter Changes - 1 year |
57.1
(8.3)
|
| Aneurysm Sac Diameter Changes - 2 year |
56.7
(8.2)
|
| Aneurysm Sac Diameter Changes - 3 year |
55.5
(8.8)
|
| Aneurysm Sac Diameter Changes - 4 year |
56.9
(10.4)
|
| Aneurysm Sac Diameter Changes - 5 year |
59.7
(13.4)
|
| Title | Clinical Utility Outcomes |
|---|---|
| Description | Clinical Utility Outcomes consists of: contrast volume and estimated blood loss. |
| Time Frame | At the time of the procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ventana Fenestrated Stent Graft System |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 76 |
| Contrast Volume |
132
(64)
|
| Blood loss |
401
(513)
|
Adverse Events
| Time Frame | 5 years | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Ventana Fenestrated Stent Graft System | |
| Arm/Group Description | 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 | |
All Cause Mortality |
||
| Ventana Fenestrated Stent Graft System | ||
| Affected / at Risk (%) | # Events | |
| Total | 30/76 (39.5%) | |
Serious Adverse Events |
||
| Ventana Fenestrated Stent Graft System | ||
| Affected / at Risk (%) | # Events | |
| Total | 50/76 (65.8%) | |
| Blood and lymphatic system disorders | ||
| Anemia | 7/76 (9.2%) | 7 |
| Hemorrhagic anemia | 1/76 (1.3%) | 1 |
| Heparin-induced thrombocytopenia | 1/76 (1.3%) | 1 |
| Cardiac disorders | ||
| AFib | 1/76 (1.3%) | 1 |
| Atrial Fibrillation | 3/76 (3.9%) | 4 |
| Atrial fibrillation with rapid ventricular response | 2/76 (2.6%) | 2 |
| Cardiac arrest | 2/76 (2.6%) | 2 |
| Cardiogenic shock | 1/76 (1.3%) | 1 |
| Cardiopulmonary arrest | 3/76 (3.9%) | 3 |
| Congestive heart failure | 2/76 (2.6%) | 2 |
| Coronary artery stenosis | 1/76 (1.3%) | 1 |
| Heart block third degree | 1/76 (1.3%) | 1 |
| Heart failure | 1/76 (1.3%) | 1 |
| Intracardiac thrombus | 1/76 (1.3%) | 1 |
| Myocardial infarction | 3/76 (3.9%) | 3 |
| Non ST segment elevation myocardial infarction | 1/76 (1.3%) | 1 |
| ST segment elevation myocardial infarction | 1/76 (1.3%) | 1 |
| Ear and labyrinth disorders | ||
| Vertigo | 1/76 (1.3%) | 1 |
| Eye disorders | ||
| Ischemic optic neuropathy | 1/76 (1.3%) | 1 |
| Gastrointestinal disorders | ||
| Abdominal pain | 1/76 (1.3%) | 1 |
| Acute pancreatitis | 1/76 (1.3%) | 2 |
| Bleeding gastrointestinal | 1/76 (1.3%) | 1 |
| Bowel ischemia | 1/76 (1.3%) | 1 |
| Bowel perforation | 1/76 (1.3%) | 1 |
| Colitis | 1/76 (1.3%) | 1 |
| Colitis ischemic | 1/76 (1.3%) | 1 |
| Diverticulosis | 1/76 (1.3%) | 1 |
| Emesis | 1/76 (1.3%) | 1 |
| GI bleed | 1/76 (1.3%) | 1 |
| Gastric ulcer perforation | 1/76 (1.3%) | 1 |
| Gastrointestinal bleed | 2/76 (2.6%) | 2 |
| Hemoperitoneum | 1/76 (1.3%) | 1 |
| Ileus | 1/76 (1.3%) | 1 |
| Inflammatory bowel disease | 1/76 (1.3%) | 1 |
| Left inguinal hernia | 2/76 (2.6%) | 2 |
| Mesenteric artery stenosis | 2/76 (2.6%) | 3 |
| Nausea | 1/76 (1.3%) | 1 |
| Necrotizing pancreatitis | 1/76 (1.3%) | 1 |
| Pancreatic duct obstruction | 1/76 (1.3%) | 1 |
| Pancreatitis | 1/76 (1.3%) | 1 |
| Peptic ulcer disease | 1/76 (1.3%) | 1 |
| Peptic ulcer hemorrhage | 1/76 (1.3%) | 1 |
| Perforated gastric ulcer | 1/76 (1.3%) | 1 |
| Small bowel obstruction | 1/76 (1.3%) | 1 |
| UGI bleed | 2/76 (2.6%) | 2 |
| General disorders | ||
| Arterial stent occlusion | 1/76 (1.3%) | 1 |
| Chest pain | 1/76 (1.3%) | 1 |
| Death | 4/76 (5.3%) | 4 |
| Device fracture | 1/76 (1.3%) | 1 |
| Device insertion difficult | 1/76 (1.3%) | 1 |
| Device issue | 5/76 (6.6%) | 5 |
| Device migration | 1/76 (1.3%) | 1 |
| Edema | 1/76 (1.3%) | 1 |
| Endoleak | 4/76 (5.3%) | 5 |
| Fatigue aggravated | 1/76 (1.3%) | 1 |
| Multi organ failure | 2/76 (2.6%) | 2 |
| Stent malfunction | 3/76 (3.9%) | 3 |
| Stent strut fracture | 4/76 (5.3%) | 5 |
| Stent-graft angulation | 1/76 (1.3%) | 1 |
| Stent-graft compression | 1/76 (1.3%) | 1 |
| Stent-graft endoleak type IB | 1/76 (1.3%) | 1 |
| Stent-graft endoleak type II | 2/76 (2.6%) | 2 |
| Stent-graft endoleak type III | 5/76 (6.6%) | 5 |
| Stent-graft malfunction | 1/76 (1.3%) | 1 |
| Stent-graft material failure | 1/76 (1.3%) | 1 |
| Vascular stent thrombosis | 1/76 (1.3%) | 1 |
| Weakness | 2/76 (2.6%) | 2 |
| Hepatobiliary disorders | ||
| Acute cholecystitis | 1/76 (1.3%) | 1 |
| Choledocholithiasis | 1/76 (1.3%) | 1 |
| Liver failure | 1/76 (1.3%) | 1 |
| Infections and infestations | ||
| Acute diverticulitis | 1/76 (1.3%) | 1 |
| Bacteremia | 1/76 (1.3%) | 1 |
| Chronic diverticulitis | 1/76 (1.3%) | 2 |
| Groin abscess | 1/76 (1.3%) | 1 |
| Incision site infection | 2/76 (2.6%) | 2 |
| Mycoplasma pneumoniae pneumonia | 1/76 (1.3%) | 1 |
| Nosocomial pneumonia | 1/76 (1.3%) | 1 |
| Pneumonia | 6/76 (7.9%) | 9 |
| Postoperative wound infection | 1/76 (1.3%) | 1 |
| Sepsis | 1/76 (1.3%) | 1 |
| Injury, poisoning and procedural complications | ||
| Ankle fracture | 1/76 (1.3%) | 1 |
| Chronic subdural hematoma | 1/76 (1.3%) | 1 |
| Fall | 1/76 (1.3%) | 1 |
| Fracture | 1/76 (1.3%) | 1 |
| Fractured femur (excl neck) | 1/76 (1.3%) | 1 |
| Fractured hip | 1/76 (1.3%) | 1 |
| Graft complication | 2/76 (2.6%) | 3 |
| Gun shot wound | 1/76 (1.3%) | 1 |
| Hematuria traumatic | 1/76 (1.3%) | 1 |
| In-stent arterial restenosis | 4/76 (5.3%) | 4 |
| Injury to iliac artery | 2/76 (2.6%) | 2 |
| Intraoperative bleeding | 1/76 (1.3%) | 1 |
| Leg fracture | 1/76 (1.3%) | 1 |
| Mental status changes postoperative | 1/76 (1.3%) | 1 |
| Muscle strain | 1/76 (1.3%) | 1 |
| Pelvic fracture | 1/76 (1.3%) | 1 |
| Post procedural complication | 1/76 (1.3%) | 1 |
| Procedural bleeding | 3/76 (3.9%) | 3 |
| Renal hematoma | 1/76 (1.3%) | 1 |
| Scalp laceration | 1/76 (1.3%) | 1 |
| Splenic hematoma | 1/76 (1.3%) | 1 |
| Subdural hematoma | 2/76 (2.6%) | 2 |
| Investigations | ||
| Creatinine increased | 1/76 (1.3%) | 1 |
| GFR decreased | 2/76 (2.6%) | 2 |
| Metabolism and nutrition disorders | ||
| Decreased appetite | 1/76 (1.3%) | 1 |
| Dehydration | 3/76 (3.9%) | 3 |
| Failure to thrive | 1/76 (1.3%) | 1 |
| Gout flare | 1/76 (1.3%) | 1 |
| Hypercalcemia | 1/76 (1.3%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Back pain | 1/76 (1.3%) | 1 |
| Flank pain | 1/76 (1.3%) | 1 |
| Knee osteoarthritis | 1/76 (1.3%) | 1 |
| weakness of Lower extremities | 1/76 (1.3%) | 1 |
| Lumbar spinal stenosis | 1/76 (1.3%) | 1 |
| Osteoarthritis knee | 1/76 (1.3%) | 1 |
| Pain in hip | 1/76 (1.3%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Adenocarcinoma | 1/76 (1.3%) | 1 |
| Brain metastases | 1/76 (1.3%) | 1 |
| Gastric adenoma | 1/76 (1.3%) | 1 |
| Lung cancer | 1/76 (1.3%) | 1 |
| Lung cancer metastatic | 1/76 (1.3%) | 1 |
| Prostate cancer | 1/76 (1.3%) | 1 |
| Small cell carcinoma | 1/76 (1.3%) | 1 |
| Thyroid carcinoma | 1/76 (1.3%) | 1 |
| Urothelial carcinoma | 2/76 (2.6%) | 2 |
| Spinal cord ischemia | 1/76 (1.3%) | 1 |
| Nervous system disorders | ||
| Carotid artery stenosis | 2/76 (2.6%) | 2 |
| Cerebral infarction | 1/76 (1.3%) | 1 |
| Cerebral vascular disturbance | 1/76 (1.3%) | 1 |
| Encephalopathy | 1/76 (1.3%) | 1 |
| Hemorrhagic transformation due to acute stroke | 1/76 (1.3%) | 1 |
| Hepatic encephalopathy | 1/76 (1.3%) | 1 |
| Intracranial hemorrhage | 1/76 (1.3%) | 1 |
| Intraventricular hemorrhage | 1/76 (1.3%) | 1 |
| Progression of Alzheimer's disease | 1/76 (1.3%) | 1 |
| Seizure | 1/76 (1.3%) | 1 |
| Stroke | 2/76 (2.6%) | 2 |
| Syncope | 2/76 (2.6%) | 3 |
| Psychiatric disorders | ||
| Confusion | 1/76 (1.3%) | 1 |
| Delirium | 1/76 (1.3%) | 1 |
| Depression | 1/76 (1.3%) | 1 |
| Major depression | 1/76 (1.3%) | 1 |
| Renal and urinary disorders | ||
| Acute kidney failure | 1/76 (1.3%) | 1 |
| Acute kidney injury | 3/76 (3.9%) | 3 |
| Acute renal failure | 3/76 (3.9%) | 3 |
| Acute tubular necrosis | 2/76 (2.6%) | 2 |
| Bilateral renal artery stenosis | 4/76 (5.3%) | 4 |
| Chronic renal failure | 2/76 (2.6%) | 2 |
| Chronic renal failure worsened | 1/76 (1.3%) | 1 |
| End stage renal disease (ESRD) | 1/76 (1.3%) | 1 |
| Hematuria | 1/76 (1.3%) | 1 |
| Renal artery dissection | 1/76 (1.3%) | 1 |
| Renal artery occlusion | 3/76 (3.9%) | 4 |
| Renal artery stenosis | 13/76 (17.1%) | 15 |
| Renal failure | 4/76 (5.3%) | 4 |
| Renal failure acute | 1/76 (1.3%) | 1 |
| Renal parenchymal hemorrhage | 1/76 (1.3%) | 1 |
| Unilateral renal artery stenosis | 1/76 (1.3%) | 1 |
| Urinary retention | 2/76 (2.6%) | 2 |
| Respiratory, thoracic and mediastinal disorders | ||
| Acute respiratory failure | 3/76 (3.9%) | 3 |
| Asphyxiation | 1/76 (1.3%) | 1 |
| Aspiration pneumonia | 1/76 (1.3%) | 1 |
| COPD exacerbation | 2/76 (2.6%) | 2 |
| Chronic obstructive pulmonary disease | 1/76 (1.3%) | 1 |
| Lung mass | 1/76 (1.3%) | 1 |
| Lung nodule | 1/76 (1.3%) | 1 |
| Pleural effusion | 2/76 (2.6%) | 2 |
| Pneumothorax | 2/76 (2.6%) | 2 |
| Pulmonary edema | 2/76 (2.6%) | 2 |
| Pulmonary embolism | 2/76 (2.6%) | 2 |
| Respiratory distress | 3/76 (3.9%) | 3 |
| Respiratory failure | 4/76 (5.3%) | 4 |
| Shortness of breath | 3/76 (3.9%) | 3 |
| Surgical and medical procedures | ||
| Surgical intervention | 1/76 (1.3%) | 1 |
| Umbilical hernia repair | 1/76 (1.3%) | 1 |
| Vascular disorders | ||
| Abdominal aneurysm, ruptured | 1/76 (1.3%) | 1 |
| Abdominal aortic aneurysm enlargement | 3/76 (3.9%) | 3 |
| Aneurysm enlargement | 1/76 (1.3%) | 1 |
| Aortic aneurysm enlargement | 1/76 (1.3%) | 1 |
| Aortic aneurysm rupture | 1/76 (1.3%) | 1 |
| Arterial stenosis | 2/76 (2.6%) | 2 |
| Arterial thrombosis | 1/76 (1.3%) | 1 |
| Celiac artery occlusion | 1/76 (1.3%) | 1 |
| Critical limb ischemia | 1/76 (1.3%) | 1 |
| DVT | 1/76 (1.3%) | 1 |
| Femoral artery occlusion | 1/76 (1.3%) | 1 |
| Femoral artery stenosis | 1/76 (1.3%) | 1 |
| Hematoma | 1/76 (1.3%) | 2 |
| Hypertension | 4/76 (5.3%) | 4 |
| Hypotension | 2/76 (2.6%) | 2 |
| Hypovolemic shock | 1/76 (1.3%) | 1 |
| Arteriovenous Fistula placement | 1/76 (1.3%) | 1 |
| Iliac artery dissection | 1/76 (1.3%) | 1 |
| Iliac artery occlusion | 2/76 (2.6%) | 2 |
Other (Not Including Serious) Adverse Events |
||
| Ventana Fenestrated Stent Graft System | ||
| Affected / at Risk (%) | # Events | |
| Total | 71/76 (93.4%) | |
| Blood and lymphatic system disorders | ||
| Anemia | 10/76 (13.2%) | 13 |
| Eosinophilia | 1/76 (1.3%) | 1 |
| Heparin-induced thrombocytopenia | 1/76 (1.3%) | 1 |
| Leukocytosis | 2/76 (2.6%) | 3 |
| Splenic infarction | 1/76 (1.3%) | 1 |
| Thrombocytopenia | 3/76 (3.9%) | 3 |
| Cardiac disorders | ||
| Acute heart failure | 1/76 (1.3%) | 1 |
| Atrial fibrillation | 4/76 (5.3%) | 4 |
| Atrial flutter | 1/76 (1.3%) | 1 |
| Bradycardia | 1/76 (1.3%) | 1 |
| Congestive heart failure | 1/76 (1.3%) | 1 |
| Paroxysmal atrial fibrillation | 1/76 (1.3%) | 1 |
| Premature atrial contraction | 1/76 (1.3%) | 1 |
| Supraventricular tachycardia | 1/76 (1.3%) | 1 |
| Demand Ischemia | 1/76 (1.3%) | 1 |
| Tachycardia | 3/76 (3.9%) | 3 |
| Uremic pericarditis | 1/76 (1.3%) | 1 |
| Congenital, familial and genetic disorders | ||
| Hydrocele | 1/76 (1.3%) | 1 |
| Hydrocele, unspecified | 1/76 (1.3%) | 1 |
| Eye disorders | ||
| Bilateral cataracts | 1/76 (1.3%) | 1 |
| Blepharospasm | 1/76 (1.3%) | 1 |
| Conjunctivitis | 1/76 (1.3%) | 1 |
| Eye pain | 1/76 (1.3%) | 1 |
| Gastrointestinal disorders | ||
| Abdominal pain | 7/76 (9.2%) | 7 |
| Bowel incontinence | 1/76 (1.3%) | 1 |
| Colitis | 2/76 (2.6%) | 2 |
| Constipation | 2/76 (2.6%) | 2 |
| Constipation aggravated | 2/76 (2.6%) | 2 |
| Crohns disease aggravated | 1/76 (1.3%) | 1 |
| Diarrhea | 2/76 (2.6%) | 2 |
| Dysphagia | 2/76 (2.6%) | 3 |
| Emesis | 1/76 (1.3%) | 1 |
| Gastric ulcer | 1/76 (1.3%) | 1 |
| Gastroesophageal reflux disease | 1/76 (1.3%) | 1 |
| Hemorrhoids | 1/76 (1.3%) | 1 |
| Ileus | 4/76 (5.3%) | 4 |
| Localized intraabdominal fluid collection | 1/76 (1.3%) | 1 |
| Nausea | 9/76 (11.8%) | 9 |
| Occlusion mesenteric artery | 1/76 (1.3%) | 1 |
| Pancreatitis | 1/76 (1.3%) | 1 |
| Retroperitoneal hematoma | 1/76 (1.3%) | 1 |
| Vomiting | 5/76 (6.6%) | 5 |
| Nodule | 1/76 (1.3%) | 1 |
| General disorders | ||
| Adverse drug reaction | 2/76 (2.6%) | 2 |
| Chest pain | 3/76 (3.9%) | 3 |
| Chest tightness | 1/76 (1.3%) | 1 |
| Device migration | 1/76 (1.3%) | 1 |
| Edema of lower extremities | 2/76 (2.6%) | 3 |
| Endoleak | 4/76 (5.3%) | 4 |
| Energy decreased | 1/76 (1.3%) | 1 |
| Fever | 2/76 (2.6%) | 2 |
| Leg edema | 1/76 (1.3%) | 1 |
| Pain | 2/76 (2.6%) | 3 |
| Rigors | 1/76 (1.3%) | 1 |
| Stent malapposition | 1/76 (1.3%) | 1 |
| Stent occlusion | 3/76 (3.9%) | 3 |
| Stent strut fracture | 5/76 (6.6%) | 5 |
| Stent-graft endoleak | 1/76 (1.3%) | 1 |
| Stent-graft endoleak type IA | 1/76 (1.3%) | 1 |
| Stent-graft endoleak type II | 6/76 (7.9%) | 6 |
| Stent-graft endoleak type III | 1/76 (1.3%) | 1 |
| Weakness | 3/76 (3.9%) | 3 |
| Weakness generalised | 1/76 (1.3%) | 1 |
| Left Arm Swelling | 1/76 (1.3%) | 1 |
| Ear Wax build-up | 1/76 (1.3%) | 1 |
| Hepatobiliary disorders | ||
| Liver cholestasis | 1/76 (1.3%) | 1 |
| Acute cystitis with hematuria | 1/76 (1.3%) | 1 |
| Infections and infestations | ||
| Acute bronchitis | 1/76 (1.3%) | 1 |
| Bronchitis | 3/76 (3.9%) | 3 |
| C.difficile colitis | 1/76 (1.3%) | 1 |
| Candidemia | 1/76 (1.3%) | 1 |
| Cellulitis | 4/76 (5.3%) | 5 |
| Clostridium difficile infection | 1/76 (1.3%) | 1 |
| Incision site cellulitis | 1/76 (1.3%) | 1 |
| Intestinal infection due to clostridium difficile | 1/76 (1.3%) | 1 |
| Left otitis externa | 1/76 (1.3%) | 1 |
| Methicillin-resistant staphylococcal aureus infection | 1/76 (1.3%) | 1 |
| Otitis externa | 1/76 (1.3%) | 1 |
| Otitis media | 1/76 (1.3%) | 1 |
| Pneumonia | 2/76 (2.6%) | 2 |
| Pyelonephritis | 1/76 (1.3%) | 1 |
| Scrotal abscess | 1/76 (1.3%) | 1 |
| Tinea corporis | 1/76 (1.3%) | 1 |
| UTI | 4/76 (5.3%) | 4 |
| Upper respiratory infection | 1/76 (1.3%) | 1 |
| Urinary tract infection | 6/76 (7.9%) | 6 |
| Shingles | 1/76 (1.3%) | 1 |
| Injury, poisoning and procedural complications | ||
| Anemia postoperative | 4/76 (5.3%) | 4 |
| Ankle injury | 1/76 (1.3%) | 1 |
| Bruising | 1/76 (1.3%) | 1 |
| Bruising of arm | 1/76 (1.3%) | 1 |
| Confusion postoperative | 1/76 (1.3%) | 1 |
| Contusion | 1/76 (1.3%) | 1 |
| Contusion of knee | 1/76 (1.3%) | 1 |
| Groin pain | 1/76 (1.3%) | 1 |
| Head injury | 1/76 (1.3%) | 1 |
| Hematoma postoperative | 1/76 (1.3%) | 1 |
| Humerus fracture | 1/76 (1.3%) | 1 |
| In-stent arterial restenosis | 1/76 (1.3%) | 1 |
| Incision site erythema | 1/76 (1.3%) | 1 |
| Incision site pain | 2/76 (2.6%) | 2 |
| Injury to hand NOS | 1/76 (1.3%) | 1 |
| Intraoperative bleeding | 1/76 (1.3%) | 1 |
| Laceration of finger | 1/76 (1.3%) | 1 |
| Laceration of leg | 1/76 (1.3%) | 1 |
| Muscle strain | 1/76 (1.3%) | 1 |
| Nausea postoperative | 1/76 (1.3%) | 1 |
| Post procedural pain | 3/76 (3.9%) | 3 |
| Postoperative bruise | 1/76 (1.3%) | 1 |
| Postoperative pain | 7/76 (9.2%) | 7 |
| Procedural bleeding | 3/76 (3.9%) | 3 |
| Seroma | 6/76 (7.9%) | 7 |
| Skull fracture NOS | 1/76 (1.3%) | 1 |
| Splenic hematoma | 1/76 (1.3%) | 1 |
| Traumatic brain injury | 1/76 (1.3%) | 1 |
| Vertebral fracture | 1/76 (1.3%) | 1 |
| Investigations | ||
| Ankle brachial index decreased | 1/76 (1.3%) | 1 |
| Blood creatinine decreased | 1/76 (1.3%) | 1 |
| Blood creatinine increased | 6/76 (7.9%) | 7 |
| Blood glucose increased | 1/76 (1.3%) | 1 |
| Blood potassium increased | 1/76 (1.3%) | 1 |
| Blood urea nitrogen increased | 1/76 (1.3%) | 1 |
| Cardiac murmur | 1/76 (1.3%) | 1 |
| Creatine kinase MB high | 1/76 (1.3%) | 1 |
| Creatine kinase increased | 1/76 (1.3%) | 1 |
| Creatinine blood increased | 3/76 (3.9%) | 3 |
| Creatinine increased | 2/76 (2.6%) | 2 |
| Decreased hemoglobin | 1/76 (1.3%) | 1 |
| Hematocrit decreased | 1/76 (1.3%) | 1 |
| Hematocrit low | 1/76 (1.3%) | 1 |
| Hemoglobin low | 1/76 (1.3%) | 1 |
| Increased serum creatinine | 3/76 (3.9%) | 3 |
| Magnesium low | 1/76 (1.3%) | 1 |
| Mean arterial pressure increased | 1/76 (1.3%) | 1 |
| Potassium increased | 1/76 (1.3%) | 1 |
| Raised INR | 1/76 (1.3%) | 2 |
| Raised WBC | 1/76 (1.3%) | 1 |
| Sodium decreased | 1/76 (1.3%) | 1 |
| Systolic murmur | 1/76 (1.3%) | 1 |
| TSH decrease | 1/76 (1.3%) | 1 |
| Urine output decreased | 2/76 (2.6%) | 2 |
| WBC increased | 1/76 (1.3%) | 1 |
| Weight loss | 2/76 (2.6%) | 2 |
| Metabolism and nutrition disorders | ||
| Acidosis | 1/76 (1.3%) | 1 |
| Diabetes mellitus | 1/76 (1.3%) | 1 |
| Electrolyte imbalance | 1/76 (1.3%) | 1 |
| Gout | 1/76 (1.3%) | 1 |
| Hyperammonemia | 1/76 (1.3%) | 1 |
| Hyperglycemia | 3/76 (3.9%) | 3 |
| Hyperkalemia | 2/76 (2.6%) | 2 |
| Hypocalcemia | 2/76 (2.6%) | 2 |
| Hypoglycemia | 1/76 (1.3%) | 1 |
| Hypokalemia | 4/76 (5.3%) | 4 |
| Hypomagnesemia | 2/76 (2.6%) | 2 |
| Hyponatremia | 1/76 (1.3%) | 1 |
| Hypophosphatemia | 1/76 (1.3%) | 1 |
| Malnutrition | 2/76 (2.6%) | 2 |
| Rotator cuff tendinitis | 1/76 (1.3%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Acute back pain | 2/76 (2.6%) | 2 |
| Arthritis | 1/76 (1.3%) | 1 |
| Axillary lump | 1/76 (1.3%) | 1 |
| Back pain | 6/76 (7.9%) | 6 |
| Buttock pain | 1/76 (1.3%) | 1 |
| Calf pain | 1/76 (1.3%) | 2 |
| Cervical spine degeneration | 1/76 (1.3%) | 1 |
| Cervicalgia | 1/76 (1.3%) | 1 |
| Chronic back pain | 1/76 (1.3%) | 1 |
| Cramp in hand | 1/76 (1.3%) | 1 |
| Flank pain | 5/76 (6.6%) | 5 |
| Foot Pain | 1/76 (1.3%) | 1 |
| Groin pain | 1/76 (1.3%) | 1 |
| Hematoma muscle | 1/76 (1.3%) | 1 |
| Knee pain | 2/76 (2.6%) | 2 |
| Leg pain | 1/76 (1.3%) | 1 |
| Low back pain | 1/76 (1.3%) | 1 |
| Lower extremities weakness of | 1/76 (1.3%) | 1 |
| Musculoskeletal chest pain | 1/76 (1.3%) | 1 |
| Polymyalgia rheumatica | 1/76 (1.3%) | 1 |
| Skin tear | 1/76 (1.3%) | 1 |
| Trigger finger | 1/76 (1.3%) | 1 |
| Weakness of arms | 1/76 (1.3%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Lung neoplasm NOS | 1/76 (1.3%) | 1 |
| Neoplasm skin | 1/76 (1.3%) | 1 |
| Prostate cancer metastatic | 1/76 (1.3%) | 1 |
| Squamous cell carcinoma | 1/76 (1.3%) | 1 |
| Nervous system disorders | ||
| Aneurysm cerebral | 1/76 (1.3%) | 1 |
| Clonus | 1/76 (1.3%) | 1 |
| Dizziness | 1/76 (1.3%) | 1 |
| Headache | 6/76 (7.9%) | 7 |
| Headache post-traumatic | 1/76 (1.3%) | 1 |
| Hemiparesis | 1/76 (1.3%) | 1 |
| Lightheadedness | 1/76 (1.3%) | 1 |
| Nerve pain | 2/76 (2.6%) | 2 |
| Neuropathy | 1/76 (1.3%) | 1 |
| Numbness in hand | 1/76 (1.3%) | 1 |
| Paresthesia lower limb | 1/76 (1.3%) | 1 |
| Parkinsonism | 1/76 (1.3%) | 1 |
| Positional dizziness | 1/76 (1.3%) | 1 |
| Restless leg syndrome | 1/76 (1.3%) | 1 |
| Sensory polyneuropathy axonal | 1/76 (1.3%) | 1 |
| Syncope | 2/76 (2.6%) | 2 |
| Product Issues | ||
| Stent-graft endoleak | 1/76 (1.3%) | 1 |
| Psychiatric disorders | ||
| Cocaine abuse | 1/76 (1.3%) | 1 |
| Delirium | 1/76 (1.3%) | 1 |
| Depression | 1/76 (1.3%) | 1 |
| Depression worsened | 1/76 (1.3%) | 1 |
| Mental status changes | 3/76 (3.9%) | 3 |
| Mood disorder NOS | 1/76 (1.3%) | 1 |
| Sleep disorder | 1/76 (1.3%) | 1 |
| Renal and urinary disorders | ||
| Acute kidney injury | 2/76 (2.6%) | 2 |
| Acute on chronic renal failure | 1/76 (1.3%) | 1 |
| Acute renal failure | 2/76 (2.6%) | 2 |
| Acute renal insufficiency | 2/76 (2.6%) | 2 |
| Atrophy kidney | 2/76 (2.6%) | 2 |
| Bladder hypertrophy | 1/76 (1.3%) | 1 |
| Bladder spasm | 1/76 (1.3%) | 1 |
| Chronic kidney disease | 1/76 (1.3%) | 1 |
| Creatinine abnormal NOS | 1/76 (1.3%) | 1 |
| Hematuria | 2/76 (2.6%) | 2 |
| Impaired renal function | 1/76 (1.3%) | 1 |
| Kidney stone | 1/76 (1.3%) | 1 |
| Renal artery occlusion | 1/76 (1.3%) | 1 |
| Renal artery stenosis | 1/76 (1.3%) | 1 |
| Renal cyst | 1/76 (1.3%) | 1 |
| Renal infarct | 1/76 (1.3%) | 1 |
| Renal infarction | 1/76 (1.3%) | 1 |
| Uremia | 1/76 (1.3%) | 1 |
| Urethral spasm | 1/76 (1.3%) | 1 |
| Urinary retention | 6/76 (7.9%) | 7 |
| Penile bleed | 1/76 (1.3%) | 1 |
| Reproductive system and breast disorders | ||
| Breast inflammation | 1/76 (1.3%) | 1 |
| Cervical cyst | 1/76 (1.3%) | 1 |
| Scrotal edema | 1/76 (1.3%) | 1 |
| Scrotal swelling | 1/76 (1.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Atelectasis | 3/76 (3.9%) | 4 |
| COPD exacerbation | 2/76 (2.6%) | 2 |
| Dyspnea | 2/76 (2.6%) | 2 |
| Emphysema | 1/76 (1.3%) | 1 |
| Hiccups | 1/76 (1.3%) | 1 |
| Lung disorder | 1/76 (1.3%) | 1 |
| Lung infiltration | 1/76 (1.3%) | 1 |
| Lung mass | 2/76 (2.6%) | 2 |
| Lung nodule | 1/76 (1.3%) | 1 |
| Pleural effusion | 3/76 (3.9%) | 4 |
| Pleural plaque | 1/76 (1.3%) | 1 |
| Pulmonary edema | 1/76 (1.3%) | 1 |
| Respiratory failure | 1/76 (1.3%) | 1 |
| Shortness of breath | 2/76 (2.6%) | 2 |
| Singers nodules | 1/76 (1.3%) | 1 |
| Sinus congestion | 1/76 (1.3%) | 1 |
| Sleep apnea | 1/76 (1.3%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Actinic keratosis | 1/76 (1.3%) | 1 |
| Angioedema | 1/76 (1.3%) | 1 |
| Decubitus ulcer | 1/76 (1.3%) | 1 |
| Dermatitis | 1/76 (1.3%) | 1 |
| Ecchymosis | 3/76 (3.9%) | 3 |
| Itching | 1/76 (1.3%) | 1 |
| Rash | 3/76 (3.9%) | 4 |
| Rash both legs | 1/76 (1.3%) | 1 |
| Skin burning sensation | 1/76 (1.3%) | 1 |
| Skin disorder NOS | 1/76 (1.3%) | 1 |
| Skin lesion | 2/76 (2.6%) | 2 |
| Skin rash | 1/76 (1.3%) | 1 |
| Skin red | 1/76 (1.3%) | 1 |
| Skin ulcer | 1/76 (1.3%) | 1 |
| Surgical and medical procedures | ||
| Arterial repair NOS | 1/76 (1.3%) | 1 |
| Vascular disorders | ||
| Abdominal aortic aneurysm enlargement | 1/76 (1.3%) | 2 |
| Aneurysm enlargement | 1/76 (1.3%) | 1 |
| Claudication | 1/76 (1.3%) | 1 |
| Deep vein thrombosis | 2/76 (2.6%) | 2 |
| Essential hypertension | 1/76 (1.3%) | 2 |
| Femoral artery dissection | 1/76 (1.3%) | 1 |
| Hematoma | 2/76 (2.6%) | 3 |
| Hypertension | 8/76 (10.5%) | 9 |
| Hypertension aggravated | 4/76 (5.3%) | 4 |
| Hypertension exacerbated | 1/76 (1.3%) | 1 |
| Hypertension worsened | 2/76 (2.6%) | 2 |
| Hypertensive crisis | 1/76 (1.3%) | 1 |
| Hypotension | 7/76 (9.2%) | 7 |
| Iliac artery aneurysm | 1/76 (1.3%) | 1 |
| Iliac artery dissection | 1/76 (1.3%) | 1 |
| Leg ischemia | 1/76 (1.3%) | 1 |
| Lymphocele | 1/76 (1.3%) | 1 |
| Orthostatic hypotension | 1/76 (1.3%) | 1 |
| Raynauds | 1/76 (1.3%) | 1 |
| Refractory hypertension | 1/76 (1.3%) | 1 |
| Vasovagal episode | 1/76 (1.3%) | 1 |
| Venous insufficiency | 1/76 (1.3%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Sripad Bellary, Director of Clinical Affairs |
|---|---|
| Organization | Endologix |
| Phone | 9257011628 |
| sbellary@endologix.com |
Responsible Party:
Endologix
ClinicalTrials.gov Identifier:
NCT01491945
Other Study ID Numbers:
- CP-0004
First Posted:
Dec 14, 2011
Last Update Posted:
Oct 15, 2021
Last Verified:
Sep 1, 2021