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

NCT ID: NCT03298477

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2025-08-16

Brief 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.

Detailed 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.

Conditions

Abdominal Aortic Aneurysm Without Rupture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System

Group Type: OTHER

Nellix® System

Intervention Type: DEVICE

Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System

Interventions

Nellix® System

Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endologix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Carpenter, MD

Role: PRINCIPAL_INVESTIGATOR

Cooper Hospital

Locations

Valley Vascular Consultants

Huntsville, Alabama, United States

Regents of the University of California (UCLA)

Los Angeles, California, United States

Veterans Medical Research Foundation

San Diego, California, United States

UC Health-Memorial Hospital

Colorado Springs, Colorado, United States

MedStar Health Research Institute

Washington D.C., District of Columbia, United States

Miami Cardiac & Vascular Institute (MCVI)

Miami, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

Coastal Vascular & Interventional

Pensacola, Florida, United States

Christie Clinic

Champaign, Illinois, United States

AMITA Health

Elk Grove Village, Illinois, United States

St. Vincent Heart Center of Indiana

Indianapolis, Indiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

McLaren Bay Region

Bay City, Michigan, United States

Midwest Aortic & Vascular Institute

Kansas City, Missouri, United States

The Cooper Health System

Camden, New Jersey, United States

New Mexico Heart Institute

Albuquerque, New Mexico, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Northeast Ohio Vascular Assoc (NEOVA)

Willoughby, Ohio, United States

OU College of Medicine

Tulsa, Oklahoma, United States

Providence St. Vincent Medical Center

Portland, Oregon, United States

Palmetto Health- University of South Carolina

Columbia, South Carolina, United States

Wellmont CVA Heart Institute

Kingsport, Tennessee, United States

Cardiovascular Surgery Clinic

Memphis, Tennessee, United States

Inova Research Center

Falls Church, Virginia, United States

Providence Sacred Heart Medical Center

Spokane, Washington, United States

Aspirus Research Institute

Wausau, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

CP-0008 EVAS2 IDE

Identifier Type: -

Identifier Source: org_study_id