Safety and Effectiveness Trial of the Ventana Fenestrated Stent Graft System

Abdominal Aortic Aneurysm Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01491945
• Other study ID #: CP-0004
• Status: Completed
• Phase: N/A
• Start date: March 3, 2013
• Est. completion date: August 1, 2018

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: August 1, 2018
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Charleston Area Medical Center	Charleston	West Virginia
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	John Muir Medical Center Concord, CA	Concord	California
United States	VA Gainesville	Gainesville	Florida
United States	Methodist Hospital	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	UCLA Medical Center	Los Angeles	California
United States	Baptist East Hospital	Louisville	Kentucky
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Arizona Heart Institute	Phoenix	Arizona
United States	UPMC	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Harborview Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Endologix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety- Number of Major Adverse Events at 30 Days	Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss >1000cc	30 Days
Primary	Effectiveness	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).	1 Year
Secondary	Safety- Number of Major Adverse Events > 30 Days to 5 Years	Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss >1000cc	>30 Days to 5 Years
Secondary	Renal Dysfunction	Renal Dysfunction is calculated at greater than 30% reduction starting at baseline	Discharge to 5 Years
Secondary	Endoleaks	Endoleaks- Type IA, Type IB, Type II, Type IIIA, Type IIIB, Type IV, and Unknown Type; Type I/III/IV Endoleak: Core Lab reported endoleak: between the endograft and the vessel either at the proximal attachment point (Type IA), or at the distal attachment point (Type IB), or between endograft components (Type III) or transgraft (Type IV).; Type II Endoleak: Core Lab reported endoleak emanating from a patent collateral vessel (e.g., inferior mesenteric artery, lumbar artery).	30 Days to 5 Years
Secondary	Clinical Utility Outcomes	Clinical Utility Outcomes consist of: fluoroscopy time, Bifurcated device placement time, Renal Artery Cannulation time, F-EVAR time and total procedure time.	At the time of the procedure
Secondary	Time in ICU	Number of days spent in the intensive care unit (ICU)	In-Hospital
Secondary	Time to Hospital Discharge	Number of days from the index procedure to discharge from the hospital.	Hospital Discharge (Post-Procedure)
Secondary	Device Patency	Device patency- Ventana & Bifurcated Occlusion, Left Renal Artery Occlusion, and Right Renal Artery Occlusion	30 Days to 5 Years
Secondary	Device Integrity	Device Integrity- Device Migration, Ventana Stent Fracture, Left Renal Stent Fracture, Right Renal Stent Fracture, and Stent Kinking/ Compression	30 Days to 5 Years
Secondary	Aneurysm Sac Morphology	Aneurysm Sac Morphology- Aneurysm Shape, Aneurysm Enlargement	30 Days to 5 Years
Secondary	Aneurysm Sac Diameter	Aneurysm Sac diameter changes	30 Days to 5 Years
Secondary	Clinical Utility Outcomes	Clinical Utility Outcomes consists of: contrast volume and estimated blood loss.	At the time of the procedure