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Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System

Prospective, Multicenter, Single Arm Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System for the Endovascular Repair of Juxtarenal/Pararenal (JAA/PAA) Aneurysms

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01348828
Enrollment
49
Registered
2011-05-05
Start date
2011-10-19
Completion date
2018-03-20
Last updated
2021-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Aortic Aneurysm

Keywords

Abdominal Aortic Aneurysm, Fenestrated, Renal Stent, Juxtarenal, Pararenal, Endologix, Renal

Brief summary

The aim of this study is to evaluate the safety and feasibility of the Endologix Fenestrated Stent Graft System for the endovascular repair of juxtarenal or pararenal aortic aneurysms.

Detailed description

The Endologix Fenestrated Stent Graft System that will be used in this study has three components, listed below: 1. Endologix unibody bifurcated stent graft 2. Endologix fenestrated proximal extension stent graft 3. Endologix renal stent graft

Interventions

DEVICEEndovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System)

Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System

Sponsors

Endologix
Lead SponsorINDUSTRY

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

* 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 \>= 70 * SMA to aortoiliac bifurcation length \>=90mm * Proximal non-aneurysmal aortic neck below the SMA with diameter 18 to 34 mm, length \>=15mm and angle \<=60° to the aneurysm sac * Angle \<=60° (clock face) between the SMA and CA * Renal arteries both at or below the SMA by \<=35mm and within 30mm of each other axially, with 4 to 8mm lumen diameter, and with clockface angle of 90° to 210° to each other * Common iliac artery distal fixation site with: distal fixation length \>=15mm, with diameter \>=10 mm and \<=23 mm and angle \<=90° to the aortic bifurcation * Ability to preserve at least one hypogastric artery

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 * Recent(within prior three months)myocardial infarction * Prior renal transplant * Length of either renal artery to be stented \<12mm * Significant occlusive disease or calcification of either renal artery (\>70%) * An essential accessory renal artery * Indispensable inferior mesenteric artery * Untreated 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

Design outcomes

Primary

MeasureTime frameDescription
Primary Safety Endpoint30 daysMajor adverse events defined as: * All-cause death * Bowel ischemia * Myocardial infarction * Paraplegia * Renal failure * Respiratory failure * Stroke * Blood loss \>=1,000cc

Secondary

MeasureTime frameDescription
Procedural/In-hospital EvaluationsProcedurally and to hospital dischargeFluoroscopy time, Renal Artery Cannulation time and procedure time
MortalityProcedurally and to 5 YearsAll-cause and aneurysm-related
Major Adverse Events>30 Days to 5 YearsAll-cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, blood loss \>1,000cc
Number of Participants With Renal Dysfunction30 Days, 6 Months and Years 1 to 5Renal Dysfunction, Renal Dysfunction In subjects with baseline eGFR\>=60 and Renal Dysfunction In subjects with baseline eGFR \<60
Aneurysm RuptureProcedurally and to 5 YearsInternal bleeding or leaking of blood from the aneurysm subsequent to the index procedure
Feasibility/Effectiveness1 YearSuccessful device delivery and deployment with patency of the renal and aortic endografts without Type I/III endoleak. 1. Treatment Success is defined as procedural technical success with device patency and the absence of type I/III endoleak 2. Procedural Technical Success is defined as a subject with successful implant. 3. Aneurysm Rupture: An aneurysm is a balloon-like bulge of an artery wall. As an aneurysm grows it puts pressure on nearby structures and may eventually rupture. 4. Clinically Significant Device Migration: Core Lab reported aortic stent graft movement \>10mm 5. 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). 6. Type II Endoleak: Core Lab reported endoleak emanating from a patent collateral vessel (e.g., inferior mesenteric artery, lumbar artery).
Device Integrity30 Days, 6 Months, and Years 1 to 5Device Migration, Ventana Stent Fracture, Left renal stent fracture, right renal stent fracture, stent Kinking/Compression
Stent Graft Patency30 Days, 6 Months, and Years 1 to 5Ventana and Bifurcated occlusion, LRA (Left renal artery) occlusion and RRA (right renal artery) occlusion
Aneurysm Diameter Change6 Months, and Years 1 to 5Change in aneurysm sac diameter - decrease \> 5mm, Increase \> 5mm, Stable (+/- 5mm) and No growth.
Secondary Procedures30 Days, 6 Month and Years 1 to 5Non-diagnostic intervention after the index procedure intended to correct or repair an endoleak (device-related: Type I (proximal or distal), Type III, Type IV; non-device related: Type II), device migration, or other device defect.
Conversion to Open RepairProcedurally and to 5 YearsOpen surgical repair of the aortic aneurysm due to unsuccessful delivery or deployment of the stent graft, due to complications or other clinical situations that precluded successful endovascular treatment, or at any time following initial successful endovascular treatment for any reason

Countries

Chile, France, Netherlands, New Zealand, United Kingdom, United States

Participant flow

Participants by arm

ArmCount
Ventana Fenestrated System
All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed. Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System): Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System
49
Total49

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyConversion2
Overall StudyDeath20
Overall Studymissed visit1
Overall StudyWithdrawals/Lost to Follow-up10

Baseline characteristics

CharacteristicVentana Fenestrated System
Age, Continuous72.6 years
STANDARD_DEVIATION 7.2
ASA Class 3 or 428 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
42 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Region of Enrollment
Chile
11 participants
Region of Enrollment
France
9 participants
Region of Enrollment
Netherlands
5 participants
Region of Enrollment
New Zealand
14 participants
Region of Enrollment
United Kingdom
6 participants
Region of Enrollment
United States
4 participants
Serum Creatinine1.1 mg/dL
STANDARD_DEVIATION 0.3
Sex: Female, Male
Female
4 Participants
Sex: Female, Male
Male
45 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
20 / 49
other
Total, other adverse events
46 / 49
serious
Total, serious adverse events
42 / 49

Outcome results

Primary

Primary Safety Endpoint

Major adverse events defined as: * All-cause death * Bowel ischemia * Myocardial infarction * Paraplegia * Renal failure * Respiratory failure * Stroke * Blood loss \>=1,000cc

Time frame: 30 days

ArmMeasureGroupValue (NUMBER)
Ventana Fenestrated SystemPrimary Safety EndpointAll Cause Death0 events
Ventana Fenestrated SystemPrimary Safety EndpointProcedural Blood Loss7 events
Ventana Fenestrated SystemPrimary Safety EndpointBowel Ischemia0 events
Ventana Fenestrated SystemPrimary Safety EndpointMyocardial Infarction0 events
Ventana Fenestrated SystemPrimary Safety EndpointParaplegia1 events
Ventana Fenestrated SystemPrimary Safety EndpointRenal Failure 1 - Temp/Perm Hemodialysis2 events
Ventana Fenestrated SystemPrimary Safety EndpointRenal Failure 2 - Serum Creat rise > 0.5mg/dL0 events
Ventana Fenestrated SystemPrimary Safety EndpointRespiratory Failure 1 - Pneumonia0 events
Ventana Fenestrated SystemPrimary Safety EndpointStroke0 events
Secondary

Aneurysm Diameter Change

Change in aneurysm sac diameter - decrease \> 5mm, Increase \> 5mm, Stable (+/- 5mm) and No growth.

Time frame: 6 Months, and Years 1 to 5

Population: All data has been entered

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Ventana Fenestrated SystemAneurysm Diameter ChangeIncrease (>5mm) - 5 Year4 Participants
Ventana Fenestrated SystemAneurysm Diameter ChangeDecrease (>5mm)- 6 Month4 Participants
Ventana Fenestrated SystemAneurysm Diameter ChangeIncrease (>5mm) - 6 Month1 Participants
Ventana Fenestrated SystemAneurysm Diameter ChangeStable (±5mm) - 6 Month34 Participants
Ventana Fenestrated SystemAneurysm Diameter ChangeNo Growth - 6 Month38 Participants
Ventana Fenestrated SystemAneurysm Diameter ChangeDecrease (>5mm)- 1 Year7 Participants
Ventana Fenestrated SystemAneurysm Diameter ChangeIncrease (>5mm) - 1 Year0 Participants
Ventana Fenestrated SystemAneurysm Diameter ChangeStable (±5mm) - 1 Year28 Participants
Ventana Fenestrated SystemAneurysm Diameter ChangeNo Growth - 1 Year35 Participants
Ventana Fenestrated SystemAneurysm Diameter ChangeDecrease (>5mm)- 2 Year9 Participants
Ventana Fenestrated SystemAneurysm Diameter ChangeIncrease (>5mm) - 2 Year8 Participants
Ventana Fenestrated SystemAneurysm Diameter ChangeStable (±5mm) - 2 Year18 Participants
Ventana Fenestrated SystemAneurysm Diameter ChangeNo Growth - 2 Year27 Participants
Ventana Fenestrated SystemAneurysm Diameter ChangeDecrease (>5mm)- 3 Year8 Participants
Ventana Fenestrated SystemAneurysm Diameter ChangeIncrease (>5mm) - 3 Year1 Participants
Ventana Fenestrated SystemAneurysm Diameter ChangeStable (±5mm) - 3 Year13 Participants
Ventana Fenestrated SystemAneurysm Diameter ChangeNo Growth - 3 Year21 Participants
Ventana Fenestrated SystemAneurysm Diameter ChangeDecrease (>5mm)- 4 Year6 Participants
Ventana Fenestrated SystemAneurysm Diameter ChangeIncrease (>5mm) - 4 Year0 Participants
Ventana Fenestrated SystemAneurysm Diameter ChangeStable (±5mm) - 4 Year10 Participants
Ventana Fenestrated SystemAneurysm Diameter ChangeNo Growth - 4 Year16 Participants
Ventana Fenestrated SystemAneurysm Diameter ChangeDecrease (>5mm)- 5 Year4 Participants
Ventana Fenestrated SystemAneurysm Diameter ChangeStable (±5mm) - 5 Year5 Participants
Ventana Fenestrated SystemAneurysm Diameter ChangeNo Growth - 5 Year9 Participants
Secondary

Aneurysm Rupture

Internal bleeding or leaking of blood from the aneurysm subsequent to the index procedure

Time frame: Procedurally and to 5 Years

Population: All available data has been reported

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Ventana Fenestrated SystemAneurysm RuptureAneurysm rupture within 30 days0 Participants
Ventana Fenestrated SystemAneurysm RuptureAneurysm rupture 30 days- 1 Year0 Participants
Ventana Fenestrated SystemAneurysm RuptureAneurysm rupture 1-2 Years1 Participants
Ventana Fenestrated SystemAneurysm RuptureAneurysm rupture 2-3 Years2 Participants
Ventana Fenestrated SystemAneurysm RuptureAneurysm rupture 3-4 Years0 Participants
Ventana Fenestrated SystemAneurysm RuptureAneurysm rupture 4-5 Years1 Participants
Secondary

Conversion to Open Repair

Open surgical repair of the aortic aneurysm due to unsuccessful delivery or deployment of the stent graft, due to complications or other clinical situations that precluded successful endovascular treatment, or at any time following initial successful endovascular treatment for any reason

Time frame: Procedurally and to 5 Years

Population: All available data has been reported

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Ventana Fenestrated SystemConversion to Open RepairOpen repair within 30 days0 Participants
Ventana Fenestrated SystemConversion to Open RepairOpen repair 30 days - 1 Year0 Participants
Ventana Fenestrated SystemConversion to Open RepairOpen repair 1 -2 Years0 Participants
Ventana Fenestrated SystemConversion to Open RepairOpen repair 2 -3 Years1 Participants
Ventana Fenestrated SystemConversion to Open RepairOpen repair 3-4 Years1 Participants
Ventana Fenestrated SystemConversion to Open RepairOpen repair 4-5 Years0 Participants
Secondary

Device Integrity

Device Migration, Ventana Stent Fracture, Left renal stent fracture, right renal stent fracture, stent Kinking/Compression

Time frame: 30 Days, 6 Months, and Years 1 to 5

Population: All data has been entered

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Ventana Fenestrated SystemDevice IntegrityVentana Stent Fracture - 1 Month0 Participants
Ventana Fenestrated SystemDevice IntegrityLeft Renal Stent Fracture - 1 Month1 Participants
Ventana Fenestrated SystemDevice IntegrityRight Renal Stent Fracture - 1 Month0 Participants
Ventana Fenestrated SystemDevice IntegrityStent Kinking/Compression - 1 Month0 Participants
Ventana Fenestrated SystemDevice IntegrityDevice Migration - 6 Month1 Participants
Ventana Fenestrated SystemDevice IntegrityVentana Stent Fracture - 6 Month1 Participants
Ventana Fenestrated SystemDevice IntegrityLeft Renal Stent Fracture - 6 Month2 Participants
Ventana Fenestrated SystemDevice IntegrityRight Renal Stent Fracture - 6 Month3 Participants
Ventana Fenestrated SystemDevice IntegrityStent Kinking/Compression - 6 Month1 Participants
Ventana Fenestrated SystemDevice IntegrityDevice Migration - 1 Year0 Participants
Ventana Fenestrated SystemDevice IntegrityVentana Stent Fracture - 1 Year3 Participants
Ventana Fenestrated SystemDevice IntegrityLeft Renal Stent Fracture - 1 Year2 Participants
Ventana Fenestrated SystemDevice IntegrityRight Renal Stent Fracture - 1 Year3 Participants
Ventana Fenestrated SystemDevice IntegrityStent Kinking/Compression - 1 Year0 Participants
Ventana Fenestrated SystemDevice IntegrityDevice Migration - 2 Year0 Participants
Ventana Fenestrated SystemDevice IntegrityVentana Stent Fracture - 2 Year3 Participants
Ventana Fenestrated SystemDevice IntegrityLeft Renal Stent Fracture - 2 Year2 Participants
Ventana Fenestrated SystemDevice IntegrityRight Renal Stent Fracture - 2 Year5 Participants
Ventana Fenestrated SystemDevice IntegrityStent Kinking/Compression - 2 Year2 Participants
Ventana Fenestrated SystemDevice IntegrityDevice Migration - 3 Year0 Participants
Ventana Fenestrated SystemDevice IntegrityVentana Stent Fracture - 3 Year4 Participants
Ventana Fenestrated SystemDevice IntegrityLeft Renal Stent Fracture - 3 Year1 Participants
Ventana Fenestrated SystemDevice IntegrityRight Renal Stent Fracture - 3 Year2 Participants
Ventana Fenestrated SystemDevice IntegrityStent Kinking/Compression - 3 Year0 Participants
Ventana Fenestrated SystemDevice IntegrityDevice Migration - 4 Year0 Participants
Ventana Fenestrated SystemDevice IntegrityVentana Stent Fracture - 4 Year4 Participants
Ventana Fenestrated SystemDevice IntegrityLeft Renal Stent Fracture - 4 Year2 Participants
Ventana Fenestrated SystemDevice IntegrityRight Renal Stent Fracture - 4 Year2 Participants
Ventana Fenestrated SystemDevice IntegrityStent Kinking/Compression - 4 Year0 Participants
Ventana Fenestrated SystemDevice IntegrityDevice Migration - 5 Year0 Participants
Ventana Fenestrated SystemDevice IntegrityVentana Stent Fracture - 5 Year4 Participants
Ventana Fenestrated SystemDevice IntegrityLeft Renal Stent Fracture - 5 Year1 Participants
Ventana Fenestrated SystemDevice IntegrityRight Renal Stent Fracture - 5 Year2 Participants
Ventana Fenestrated SystemDevice IntegrityStent Kinking/Compression - 5 Year0 Participants
Secondary

Feasibility/Effectiveness

Successful device delivery and deployment with patency of the renal and aortic endografts without Type I/III endoleak. 1. Treatment Success is defined as procedural technical success with device patency and the absence of type I/III endoleak 2. Procedural Technical Success is defined as a subject with successful implant. 3. Aneurysm Rupture: An aneurysm is a balloon-like bulge of an artery wall. As an aneurysm grows it puts pressure on nearby structures and may eventually rupture. 4. Clinically Significant Device Migration: Core Lab reported aortic stent graft movement \>10mm 5. 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). 6. Type II Endoleak: Core Lab reported endoleak emanating from a patent collateral vessel (e.g., inferior mesenteric artery, lumbar artery).

Time frame: 1 Year

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Ventana Fenestrated SystemFeasibility/EffectivenessTreatment Success31 Participants
Ventana Fenestrated SystemFeasibility/EffectivenessUnsuccessful Treatment18 Participants
Ventana Fenestrated SystemFeasibility/EffectivenessProcedural Technical Success47 Participants
Ventana Fenestrated SystemFeasibility/EffectivenessAneurysm Rupture1 Participants
Ventana Fenestrated SystemFeasibility/EffectivenessConversion to open repair1 Participants
Ventana Fenestrated SystemFeasibility/EffectivenessSecondary Interventions13 Participants
Ventana Fenestrated SystemFeasibility/EffectivenessAneurysm Enlargement3 Participants
Ventana Fenestrated SystemFeasibility/EffectivenessClinically Significant Migration1 Participants
Ventana Fenestrated SystemFeasibility/EffectivenessType IA Endoleak0 Participants
Ventana Fenestrated SystemFeasibility/EffectivenessType IB Endoleak0 Participants
Ventana Fenestrated SystemFeasibility/EffectivenessType IIIA Endoleak3 Participants
Ventana Fenestrated SystemFeasibility/EffectivenessType IIIB Endoleak2 Participants
Secondary

Major Adverse Events

All-cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, blood loss \>1,000cc

Time frame: >30 Days to 5 Years

ArmMeasureGroupValue (NUMBER)
Ventana Fenestrated SystemMajor Adverse EventsAll Cause Death6 Number of events
Ventana Fenestrated SystemMajor Adverse EventsBowel Ischemia0 Number of events
Ventana Fenestrated SystemMajor Adverse EventsMyocardial Infarction2 Number of events
Ventana Fenestrated SystemMajor Adverse EventsParaplegia0 Number of events
Ventana Fenestrated SystemMajor Adverse EventsProcedural Blood loss0 Number of events
Ventana Fenestrated SystemMajor Adverse EventsRenal Failure 1 - Temp/Perm Hemodialysis4 Number of events
Ventana Fenestrated SystemMajor Adverse EventsRenal Failure 2 - Serum Creat rise >0.5mg/dL1 Number of events
Ventana Fenestrated SystemMajor Adverse EventsRespiratory Failure 1 - Pneumonia2 Number of events
Ventana Fenestrated SystemMajor Adverse EventsStroke0 Number of events
Secondary

Mortality

All-cause and aneurysm-related

Time frame: Procedurally and to 5 Years

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Ventana Fenestrated SystemMortalityAll Cause Deaths20 Participants
Ventana Fenestrated SystemMortalityAneurysm Related Deaths5 Participants
Secondary

Number of Participants With Renal Dysfunction

Renal Dysfunction, Renal Dysfunction In subjects with baseline eGFR\>=60 and Renal Dysfunction In subjects with baseline eGFR \<60

Time frame: 30 Days, 6 Months and Years 1 to 5

Population: All available data has been reported

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Ventana Fenestrated SystemNumber of Participants With Renal DysfunctionRenal Dysfunction-1 Month4 Participants
Ventana Fenestrated SystemNumber of Participants With Renal DysfunctionRenal Dysfunction in subjects with Baseline eGFR >=60 - 1 Month2 Participants
Ventana Fenestrated SystemNumber of Participants With Renal DysfunctionRenal Dysfunction in subjects with Baseline eGFR <60 - 1 Month2 Participants
Ventana Fenestrated SystemNumber of Participants With Renal DysfunctionRenal Dysfunction-6 Month9 Participants
Ventana Fenestrated SystemNumber of Participants With Renal DysfunctionRenal Dysfunction in subjects with Baseline eGFR >=60 - 6 Month5 Participants
Ventana Fenestrated SystemNumber of Participants With Renal DysfunctionRenal Dysfunction in subjects with Baseline eGFR <60 - 6 Month4 Participants
Ventana Fenestrated SystemNumber of Participants With Renal DysfunctionRenal Dysfunction-1 Year13 Participants
Ventana Fenestrated SystemNumber of Participants With Renal DysfunctionRenal Dysfunction in subjects with Baseline eGFR >=60 - 1 Year7 Participants
Ventana Fenestrated SystemNumber of Participants With Renal DysfunctionRenal Dysfunction in subjects with Baseline eGFR <60 - 1 Year6 Participants
Ventana Fenestrated SystemNumber of Participants With Renal DysfunctionRenal Dysfunction- 2 Year7 Participants
Ventana Fenestrated SystemNumber of Participants With Renal DysfunctionRenal Dysfunction in subjects with Baseline eGFR >=60 - 2 Year4 Participants
Ventana Fenestrated SystemNumber of Participants With Renal DysfunctionRenal Dysfunction in subjects with Baseline eGFR <60 - 2 Year3 Participants
Ventana Fenestrated SystemNumber of Participants With Renal DysfunctionRenal Dysfunction- 3 Year5 Participants
Ventana Fenestrated SystemNumber of Participants With Renal DysfunctionRenal Dysfunction in subjects with Baseline eGFR >=60 - 3 Year3 Participants
Ventana Fenestrated SystemNumber of Participants With Renal DysfunctionRenal Dysfunction in subjects with Baseline eGFR <60 - 3 Year2 Participants
Ventana Fenestrated SystemNumber of Participants With Renal DysfunctionRenal Dysfunction-4 Year3 Participants
Ventana Fenestrated SystemNumber of Participants With Renal DysfunctionRenal Dysfunction in subjects with Baseline eGFR >=60 - 4 Year2 Participants
Ventana Fenestrated SystemNumber of Participants With Renal DysfunctionRenal Dysfunction in subjects with Baseline eGFR <60 - 4 Year1 Participants
Ventana Fenestrated SystemNumber of Participants With Renal DysfunctionRenal Dysfunction- 5 Year4 Participants
Ventana Fenestrated SystemNumber of Participants With Renal DysfunctionRenal Dysfunction in subjects with Baseline eGFR >=60 - 5 Year2 Participants
Ventana Fenestrated SystemNumber of Participants With Renal DysfunctionRenal Dysfunction in subjects with Baseline eGFR <60 - 5 Year2 Participants
Secondary

Procedural/In-hospital Evaluations

Fluoroscopy time, Renal Artery Cannulation time and procedure time

Time frame: Procedurally and to hospital discharge

ArmMeasureGroupValue (MEAN)Dispersion
Ventana Fenestrated SystemProcedural/In-hospital EvaluationsFluoroscopy Time58 minutesStandard Deviation 37
Ventana Fenestrated SystemProcedural/In-hospital EvaluationsRenal Artery Cannulation Time51 minutesStandard Deviation 57
Ventana Fenestrated SystemProcedural/In-hospital EvaluationsTotal Procedure Time202 minutesStandard Deviation 72
Secondary

Procedural/In-hospital Evaluations

Contrast volume and estimated blood loss

Time frame: Procedurally and to hospital discharge

ArmMeasureGroupValue (MEAN)Dispersion
Ventana Fenestrated SystemProcedural/In-hospital EvaluationsContrast Volume205 mLStandard Deviation 107
Ventana Fenestrated SystemProcedural/In-hospital EvaluationsBlood Loss581 mLStandard Deviation 396
Secondary

Procedural/In-hospital Evaluations

Time to hospital discharge

Time frame: Discharge

ArmMeasureValue (MEAN)Dispersion
Ventana Fenestrated SystemProcedural/In-hospital Evaluations5 daysStandard Deviation 4
Secondary

Secondary Procedures

Non-diagnostic intervention after the index procedure intended to correct or repair an endoleak (device-related: Type I (proximal or distal), Type III, Type IV; non-device related: Type II), device migration, or other device defect.

Time frame: 30 Days, 6 Month and Years 1 to 5

Population: All data has been entered

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Ventana Fenestrated SystemSecondary ProceduresSMA Artery Occlusion- 3 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresSMA Artery Occlusion- 4 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresAneurysm Expansion - Conversion to open repair - 30 days0 Participants
Ventana Fenestrated SystemSecondary ProceduresAneurysm Expansion - Conversion to open repair - 6 Month0 Participants
Ventana Fenestrated SystemSecondary ProceduresAneurysm Expansion - Conversion to open repair - 1 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresAneurysm Expansion - Conversion to open repair - 2 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresAneurysm Expansion - Conversion to open repair - 3 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresAneurysm Expansion - Conversion to open repair - 4 Year1 Participants
Ventana Fenestrated SystemSecondary ProceduresAneurysm Expansion - Conversion to open repair - 5 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresAneurysm Rupture - Conversion to open repair - 30 days0 Participants
Ventana Fenestrated SystemSecondary ProceduresAneurysm Rupture - Conversion to open repair - 6 Month0 Participants
Ventana Fenestrated SystemSecondary ProceduresAneurysm Rupture - Conversion to open repair - 1 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresAneurysm Rupture - Conversion to open repair - 2 Year1 Participants
Ventana Fenestrated SystemSecondary ProceduresAneurysm Rupture - Conversion to open repair - 3 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresAneurysm Rupture - Conversion to open repair - 4 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresAneurysm Rupture - Conversion to open repair - 5 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresAortic Occlusion -Bypass - Other- 30 Days0 Participants
Ventana Fenestrated SystemSecondary ProceduresAortic Occlusion -Bypass - Other- 6 Month0 Participants
Ventana Fenestrated SystemSecondary ProceduresAortic Occlusion -Bypass - Other- 1 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresAortic Occlusion -Bypass - Other- 2 Year1 Participants
Ventana Fenestrated SystemSecondary ProceduresAortic Occlusion -Bypass - Other- 3 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresAortic Occlusion -Bypass - Other- 4 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresAortic Occlusion -Bypass - Other- 5 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresDevice Migration - Renal Stenting - 30 Days0 Participants
Ventana Fenestrated SystemSecondary ProceduresDevice Migration - Renal Stenting - 6 Month0 Participants
Ventana Fenestrated SystemSecondary ProceduresDevice Migration - Renal Stenting - 1 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresDevice Migration - Renal Stenting - 2 Year1 Participants
Ventana Fenestrated SystemSecondary ProceduresDevice Migration - Renal Stenting - 3 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresDevice Migration - Renal Stenting 4 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresDevice Migration - Renal Stenting - 5 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresIliac Artery Stenosis/Occlusion - 30 Days2 Participants
Ventana Fenestrated SystemSecondary ProceduresIliac Artery Stenosis/Occlusion - 6 Month1 Participants
Ventana Fenestrated SystemSecondary ProceduresIliac Artery Stenosis/Occlusion - 1 Year3 Participants
Ventana Fenestrated SystemSecondary ProceduresIliac Artery Stenosis/Occlusion - 2 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresIliac Artery Stenosis/Occlusion - 3 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresIliac Artery Stenosis/Occlusion - 4 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresIliac Artery Stenosis/Occlusion - 5 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresRenal Artery Stenosis/Occlusion - 30 Days0 Participants
Ventana Fenestrated SystemSecondary ProceduresRenal Artery Stenosis/Occlusion - 6 Month9 Participants
Ventana Fenestrated SystemSecondary ProceduresRenal Artery Stenosis/Occlusion - 1 Year9 Participants
Ventana Fenestrated SystemSecondary ProceduresRenal Artery Stenosis/Occlusion - 2 Year2 Participants
Ventana Fenestrated SystemSecondary ProceduresRenal Artery Stenosis/Occlusion - 3 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresRenal Artery Stenosis/Occlusion - 4 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresRenal Artery Stenosis/Occlusion - 5 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresSMA Artery Occlusion- 30 Days1 Participants
Ventana Fenestrated SystemSecondary ProceduresSMA Artery Occlusion- 6 Month0 Participants
Ventana Fenestrated SystemSecondary ProceduresSMA Artery Occlusion- 1 Year1 Participants
Ventana Fenestrated SystemSecondary ProceduresSMA Artery Occlusion- 2 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresSMA Artery Occlusion- 5 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresStent Fracture - 30 Days0 Participants
Ventana Fenestrated SystemSecondary ProceduresStent Fracture - 6 Month0 Participants
Ventana Fenestrated SystemSecondary ProceduresStent Fracture - 1 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresStent Fracture - 2 Year1 Participants
Ventana Fenestrated SystemSecondary ProceduresStent Fracture - 3 Year2 Participants
Ventana Fenestrated SystemSecondary ProceduresStent Fracture - 4 Year1 Participants
Ventana Fenestrated SystemSecondary ProceduresStent Fracture - 5 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresStent Migration - 30 Days0 Participants
Ventana Fenestrated SystemSecondary ProceduresStent Migration - 6 Month0 Participants
Ventana Fenestrated SystemSecondary ProceduresStent Migration - 1 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresStent Migration - 2 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresStent Migration - 3 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresStent Migration - 4 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresStent Migration - 5 Year1 Participants
Ventana Fenestrated SystemSecondary ProceduresType IA Endoleak - 30 Days0 Participants
Ventana Fenestrated SystemSecondary ProceduresType IA Endoleak - 6 Month1 Participants
Ventana Fenestrated SystemSecondary ProceduresType IA Endoleak - 1 Year1 Participants
Ventana Fenestrated SystemSecondary ProceduresType IA Endoleak - 2 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresType IA Endoleak - 3 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresType IA Endoleak - 4 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresType IA Endoleak - 5 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresLiquid Embolization - 30 Days0 Participants
Ventana Fenestrated SystemSecondary ProceduresLiquid Embolization - 6 Month1 Participants
Ventana Fenestrated SystemSecondary ProceduresLiquid Embolization - 1 Year1 Participants
Ventana Fenestrated SystemSecondary ProceduresLiquid Embolization - 2 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresLiquid Embolization - 3 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresLiquid Embolization - 4 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresLiquid Embolization - 5 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresType IB Endoleak - 30 Days0 Participants
Ventana Fenestrated SystemSecondary ProceduresType IB Endoleak - 6 Month0 Participants
Ventana Fenestrated SystemSecondary ProceduresType IB Endoleak - 1 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresType IB Endoleak - 2 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresType IB Endoleak - 3 Year1 Participants
Ventana Fenestrated SystemSecondary ProceduresType IB Endoleak - 4 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresType IB Endoleak - 5 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresConversion to Open Repair - 30 Days0 Participants
Ventana Fenestrated SystemSecondary ProceduresConversion to Open Repair - 6 Month0 Participants
Ventana Fenestrated SystemSecondary ProceduresConversion to Open Repair - 1 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresConversion to Open Repair - 2 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresConversion to Open Repair - 3 Year1 Participants
Ventana Fenestrated SystemSecondary ProceduresConversion to Open Repair - 4 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresConversion to Open Repair - 5 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresType II Endoleak - 30 Days0 Participants
Ventana Fenestrated SystemSecondary ProceduresType II Endoleak - 6 Month0 Participants
Ventana Fenestrated SystemSecondary ProceduresType II Endoleak - 1 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresType II Endoleak - 2 Year1 Participants
Ventana Fenestrated SystemSecondary ProceduresType II Endoleak - 3 Year1 Participants
Ventana Fenestrated SystemSecondary ProceduresType II Endoleak - 4 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresType II Endoleak - 5 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresCoil Embolization - 30 Days0 Participants
Ventana Fenestrated SystemSecondary ProceduresCoil Embolization - 6 Month0 Participants
Ventana Fenestrated SystemSecondary ProceduresCoil Embolization - 1 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresCoil Embolization - 2 Year1 Participants
Ventana Fenestrated SystemSecondary ProceduresCoil Embolization - 3 Year1 Participants
Ventana Fenestrated SystemSecondary ProceduresCoil Embolization - 4 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresCoil Embolization - 5 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresType III Endoleak - 30 Days1 Participants
Ventana Fenestrated SystemSecondary ProceduresType III Endoleak - 6 Month1 Participants
Ventana Fenestrated SystemSecondary ProceduresType III Endoleak - 1 Year2 Participants
Ventana Fenestrated SystemSecondary ProceduresType III Endoleak - 2 Year2 Participants
Ventana Fenestrated SystemSecondary ProceduresType III Endoleak - 3 Year4 Participants
Ventana Fenestrated SystemSecondary ProceduresType III Endoleak - 4 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresType III Endoleak - 5 Year1 Participants
Ventana Fenestrated SystemSecondary ProceduresAortic Extension- 30 Days0 Participants
Ventana Fenestrated SystemSecondary ProceduresAortic Extension- 6 Month0 Participants
Ventana Fenestrated SystemSecondary ProceduresAortic Extension- 1 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresAortic Extension- 2 Year1 Participants
Ventana Fenestrated SystemSecondary ProceduresAortic Extension- 3 Year2 Participants
Ventana Fenestrated SystemSecondary ProceduresAortic Extension- 4 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresAortic Extension- 5 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresAortic Revision - 30 Days0 Participants
Ventana Fenestrated SystemSecondary ProceduresAortic Revision - 6 Month1 Participants
Ventana Fenestrated SystemSecondary ProceduresAortic Revision - 1 Year1 Participants
Ventana Fenestrated SystemSecondary ProceduresAortic Revision - 2 Year1 Participants
Ventana Fenestrated SystemSecondary ProceduresAortic Revision - 3 Year2 Participants
Ventana Fenestrated SystemSecondary ProceduresAortic Revision - 4 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresAortic Revision - 5 Year1 Participants
Ventana Fenestrated SystemSecondary ProceduresBalloon Angioplasty - 30 Days1 Participants
Ventana Fenestrated SystemSecondary ProceduresBalloon Angioplasty - 6 Month0 Participants
Ventana Fenestrated SystemSecondary ProceduresBalloon Angioplasty - 1 Year1 Participants
Ventana Fenestrated SystemSecondary ProceduresBalloon Angioplasty - 2 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresBalloon Angioplasty - 3 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresBalloon Angioplasty - 4 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresBalloon Angioplasty - 5 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresIliac Extension - 30 Days0 Participants
Ventana Fenestrated SystemSecondary ProceduresIliac Extension - 6 Month0 Participants
Ventana Fenestrated SystemSecondary ProceduresIliac Extension - 1 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresIliac Extension - 2 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresIliac Extension - 3 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresIliac Extension - 4 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresIliac Extension - 5 Year1 Participants
Ventana Fenestrated SystemSecondary ProceduresRenal Stenting - 30 Days0 Participants
Ventana Fenestrated SystemSecondary ProceduresRenal Stenting - 6 Month0 Participants
Ventana Fenestrated SystemSecondary ProceduresRenal Stenting - 1 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresRenal Stenting - 2 Year1 Participants
Ventana Fenestrated SystemSecondary ProceduresRenal Stenting - 3 Year1 Participants
Ventana Fenestrated SystemSecondary ProceduresRenal Stenting - 4 Year0 Participants
Ventana Fenestrated SystemSecondary ProceduresRenal Stenting - 5 Year0 Participants
Secondary

Stent Graft Patency

Ventana and Bifurcated occlusion, LRA (Left renal artery) occlusion and RRA (right renal artery) occlusion

Time frame: 30 Days, 6 Months, and Years 1 to 5

Population: All available data has been entered.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Ventana Fenestrated SystemStent Graft PatencyVentana and Bifurcated occlusion - 1 Month0 Participants
Ventana Fenestrated SystemStent Graft PatencyLRA Occlusion - 1 Month0 Participants
Ventana Fenestrated SystemStent Graft PatencyRRA Occlusion - 1 Month0 Participants
Ventana Fenestrated SystemStent Graft PatencyVentana and Bifurcated Occlusion - 6 Month0 Participants
Ventana Fenestrated SystemStent Graft PatencyLRA Occlusion - 6 Month1 Participants
Ventana Fenestrated SystemStent Graft PatencyRRA Occlusion - 6 Month1 Participants
Ventana Fenestrated SystemStent Graft PatencyVentana and Bifurcated occlusion - 1 Year1 Participants
Ventana Fenestrated SystemStent Graft PatencyLRA Occlusion - 1 Year1 Participants
Ventana Fenestrated SystemStent Graft PatencyRRA Occlusion - 1 Year1 Participants
Ventana Fenestrated SystemStent Graft PatencyVentana and Bifurcated occlusion - 2 Year1 Participants
Ventana Fenestrated SystemStent Graft PatencyLRA Occlusion - 2 Year4 Participants
Ventana Fenestrated SystemStent Graft PatencyRRA Occlusion - 2 Year1 Participants
Ventana Fenestrated SystemStent Graft PatencyVentana and Bifurcated occlusion - 3 Year0 Participants
Ventana Fenestrated SystemStent Graft PatencyLRA Occlusion - 3 Year1 Participants
Ventana Fenestrated SystemStent Graft PatencyRRA Occlusion - 3 Year0 Participants
Ventana Fenestrated SystemStent Graft PatencyVentana and Bifurcated occlusion - 4 Year0 Participants
Ventana Fenestrated SystemStent Graft PatencyLRA Occlusion - 4 Year1 Participants
Ventana Fenestrated SystemStent Graft PatencyRRA Occlusion - 4 Year0 Participants
Ventana Fenestrated SystemStent Graft PatencyVentana and Bifurcated occlusion - 5 Year0 Participants
Ventana Fenestrated SystemStent Graft PatencyLRA Occlusion - 5 Year2 Participants
Ventana Fenestrated SystemStent Graft PatencyRRA Occlusion - 5 Year1 Participants

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026