Feasibility and Safety Study of the Endologix Fenestrated... | NCT01348828

NCT01348828

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Arm	Other	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.	Device: Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System)	Device	Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	30 days

Secondary Outcomes

Measure	Description	Time Frame
Feasibility/Effectiveness	Successful device delivery and deployment with patency of the renal and aortic endografts without Type I/III endoleak. Treatment Success is defined as procedural technical success with device patency and the absence of type I/III endoleak Procedural Technical Success is defined as a subject with successful implant. 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. 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).

Eligibility Module

Eligibility Criteria

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

Name	Affiliation	Role
Daniel Clair, MD	The Cleveland Clinic	Principal Investigator
Andrew Holden, MD	Auckland City Hospital	Principal Investigator
Renato Mertens, MD	Hospital Universidad Catolica	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
UCLA		Los Angeles	California	90024	United States
University of Indiana

PubMed Identifier	Type	Citation	Retractions
22545881	Derived	Mertens R, Bergoeing M, Marine L, Valdes F, Kramer A, Vergara J. Ventana fenestrated stent-graft system for endovascular repair of juxtarenal aortic aneurysms. J Endovasc Ther. 2012 Apr;19(2):173-8. doi: 10.1583/11-3706.1.

Arm/Group Information

ID	Title	Description
FG000	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

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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

Posted

Number

events

30 days

ID	Title	Description
OG000	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

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 15, 2012	Jul 29, 2021	Prot_SAP_000.pdf
ICF	No	No	Yes	Informed Consent Form	Jan 9, 2012	Sep 20, 2021	ICF_001.pdf

ID	Term
D001014	Aortic Aneurysm
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases