Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System

Abdominal Aortic Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01348828
• Other study ID #: CP-0003
• Status: Completed
• Phase: N/A
• Start date: October 19, 2011
• Est. completion date: March 20, 2018

Study information

• Verified date: September 2021
• Source: Endologix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 20, 2018
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System)
Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System

Locations

Country	Name	City	State
Chile	Hospital Universidad Catolica	Santiago
France	Bureau de Recherche Clinique	Creteil
Netherlands	Rijnstate Hospital	Arnhem
New Zealand	Auckland City Hospital	Auckland
United Kingdom	St. George's Vascular Institute	London
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University of Indiana	Indianapolis	Indiana
United States	UCLA	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Endologix

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
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	30 days
Secondary	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).	1 Year
Secondary	Procedural/In-hospital Evaluations	Fluoroscopy time, Renal Artery Cannulation time and procedure time	Procedurally and to hospital discharge
Secondary	Mortality	All-cause and aneurysm-related	Procedurally and to 5 Years
Secondary	Major Adverse Events	All-cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, blood loss >1,000cc	>30 Days to 5 Years
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	30 Days, 6 Months and Years 1 to 5
Secondary	Aneurysm Rupture	Internal bleeding or leaking of blood from the aneurysm subsequent to the index procedure	Procedurally and to 5 Years
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	Procedurally and to 5 Years
Secondary	Device Integrity	Device Migration, Ventana Stent Fracture, Left renal stent fracture, right renal stent fracture, stent Kinking/Compression	30 Days, 6 Months, and Years 1 to 5
Secondary	Stent Graft Patency	Ventana and Bifurcated occlusion, LRA (Left renal artery) occlusion and RRA (right renal artery) occlusion	30 Days, 6 Months, and Years 1 to 5
Secondary	Aneurysm Diameter Change	Change in aneurysm sac diameter - decrease > 5mm, Increase > 5mm, Stable (+/- 5mm) and No growth.	6 Months, and Years 1 to 5
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.	30 Days, 6 Month and Years 1 to 5
Secondary	Procedural/In-hospital Evaluations	Contrast volume and estimated blood loss	Procedurally and to hospital discharge
Secondary	Procedural/In-hospital Evaluations	Time to hospital discharge	Discharge