EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study

Abdominal Aortic Aneurysm Without Rupture Clinical Trial

— EVAS2  

Official title:

Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix System IDE Study (EVAS 2 Confirmatory IDE Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03298477
• Other study ID #: CP-0008 EVAS2 IDE
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: August 16, 2025

Study information

• Verified date: March 2024
• Source: Endologix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System.

Description:

This study will evaluate the safety and effectiveness of the Nellix System among a wide range of physicians and in consecutively enrolled subjects to assess safety and effectiveness outcomes. Following appropriate government and ethics committee/IRB approval the Nellix® EndoVascular Sealing System will be implanted into eligible patients who are adequately informed and have consented to join the study. Enrolled patients will undergo a high resolution, contrast-enhanced computed tomography angiography (CT) scan of the relevant aortic and aortoiliac vasculature within three months of the scheduled procedure and at specified follow-up intervals post-implantation. Follow-up visits will occur at 30 days, 6 months, and annually to 5 years to assess aneurysm morphology, the status of the implanted devices, and relevant laboratory test results.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 98
• Est. completion date: August 16, 2025
• Est. primary completion date: June 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

INCLUSION CRITERIA

A patient who meets all of the following criteria potentially may be included in the study:

1. Male or female at least 18 years old;

2. Informed consent form understood and signed

3. Patient agrees to all follow-up visits;

4. Abdominal aortic aneurysm with sac diameter =5.0cm, or =4.5cm which has increased by =0.5cm within the last 6 months, or or which exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. No AAA <4 cm will be included.

5. Anatomically eligible for the Nellix System (per Instructions For Use):

1. Adequate iliac/femoral access compatible with the required delivery systems (diameter =6 mm);

2. Aneurysm blood lumen diameter =60mm;

3. Proximal non-aneurysmal aortic neck: length =10mm; diameter 18 to 28mm; angle =60° to the aneurysm sac;

4. Most caudal renal artery to each hypogastric artery length =100mm;

5. Common iliac artery lumen diameter between 9 and 35mm;

6. Distal iliac artery seal zone with length of =10mm and diameter range of 9 to 25mm;

7. Ability to preserve at least one hypogastric artery.

8. Ratio of maximum aortic aneurysm diameter to maximum aortic blood lumen diameter <1.40 EXCLUSION CRITERIA A patient who meets none of the following criteria potentially may be included in the

study:

1. Life expectancy <2 years as judged by the Investigator;

2. Psychiatric or other condition that may interfere with the study;

3. Participating in another clinical study;

4. Known allergy or contraindication to any device material;

5. Coagulopathy or uncontrolled bleeding disorder;

6. Ruptured, leaking or mycotic aneurysm;

7. Serum creatinine (S-Cr) level >2.0 mg/dL;

8. CVA or MI within three months of enrollment/treatment;

9. Aneurysmal disease of the descending thoracic aorta;

10. Clinically significant mural thrombus within the proximal landing zone (minimum 10mm) of the infrarenal non-aneurysmal neck (>5mm thickness over >50% circumference);

11. Connective tissue diseases (e.g., Marfan Syndrome);

12. Unsuitable vascular anatomy that may interfere with device introduction or deployment;

13. Pregnant (female of childbearing potential only).

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm Without Rupture
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Rupture

Intervention

Device:
• Nellix® System
Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System

Locations

Country	Name	City	State
United States	New Mexico Heart Institute	Albuquerque	New Mexico
United States	McLaren Bay Region	Bay City	Michigan
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	The Cooper Health System	Camden	New Jersey
United States	Christie Clinic	Champaign	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	UC Health-Memorial Hospital	Colorado Springs	Colorado
United States	Palmetto Health- University of South Carolina	Columbia	South Carolina
United States	AMITA Health	Elk Grove Village	Illinois
United States	Inova Research Center	Falls Church	Virginia
United States	Valley Vascular Consultants	Huntsville	Alabama
United States	St. Vincent Heart Center of Indiana	Indianapolis	Indiana
United States	Midwest Aortic & Vascular Institute	Kansas City	Missouri
United States	Wellmont CVA Heart Institute	Kingsport	Tennessee
United States	Regents of the University of California (UCLA)	Los Angeles	California
United States	Cardiovascular Surgery Clinic	Memphis	Tennessee
United States	Miami Cardiac & Vascular Institute (MCVI)	Miami	Florida
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	AdventHealth Orlando	Orlando	Florida
United States	Coastal Vascular & Interventional	Pensacola	Florida
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Veterans Medical Research Foundation	San Diego	California
United States	Providence Sacred Heart Medical Center	Spokane	Washington
United States	OU College of Medicine	Tulsa	Oklahoma
United States	MedStar Health Research Institute	Washington	District of Columbia
United States	Aspirus Research Institute	Wausau	Wisconsin
United States	Northeast Ohio Vascular Assoc (NEOVA)	Willoughby	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Endologix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Major Adverse Events (MAE)	All cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, procedural blood loss >1,000cc	30 days
Primary	Rate of Treatment Success	Procedural technical success and the absence of aneurysm rupture, conversion to open surgical repair, Type I endoleak at 12 months, Type III endoleak at 12 months, aneurysm enlargement, secondary procedure for resolution of endoleak (Type I or III), limb occlusion, migration, aneurysm sac expansion and/or a device defect	1 year