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

NCT03298477 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: CP-0008 EVAS2 IDE
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 27

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.

Conditions

Abdominal Aortic Aneurysm Without Rupture

Outcome Measures

Primary Outcomes (2)

• Safety: Major Adverse Events (MAE)

  The primary safety endpoint is defined as the incidence of Major Adverse Events (MAE) at 30 days, defined as the composite of the following All-Cause Mortality; Bowel Ischemia; Myocardial Infarction; Paraplegia; Renal Failure; Respiratory Failure; Stroke; Procedural Blood Loss ≥1,000cc

  30 days

• Effectiveness: Rate of Treatment Success

  The primary effectiveness endpoint is defined as the rate of Treatment Success at year 2. Treatment Success is a composite of outcomes clinically relevant to the endovascular repair of infrarenal AAA as follows: It is defined as procedural technical success and absence of Abdominal aortic aneurysm rupture; Conversion to open surgical repair; Endoleak Type I or III at year 2; Clinically significant migration; \> 5mm aneurysm sac enlargement of the maximal diameter as measured by the difference from the 30-Day CT time point; or Secondary endovascular procedure up to year 2 for resolution of Endoleak (Type I or Type III), Device obstruction or occlusion, Device migration, Abdominal aneurysm sac expansion, Device defect.

  2 year

Secondary Outcomes (8)

• Conversions, Death and Ruptures

  2 Years

• Device Integrity

  2 Years

• Device Performance - Endoleak

  2 Years

• DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Avg Size

  2 years

• DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Changes in Sac Size Since 01 Month

  2 Years

Study Arms (1)

Single Arm

OTHER

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

Device: Nellix® System

Interventions

Nellix® System DEVICE

Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A patient who meets all of the following criteria potentially may be included in the study:
• Male or female at least 18 years old;
• Informed consent form understood and signed
• Patient agrees to all follow-up visits;
• 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.
• Anatomically eligible for the Nellix System (per Instructions For Use):
• Adequate iliac/femoral access compatible with the required delivery systems (diameter ≥6 mm);
• Aneurysm blood lumen diameter ≤60mm;
• Proximal non-aneurysmal aortic neck: length ≥10mm; diameter 18 to 28mm; angle ≤60° to the aneurysm sac;
• Most caudal renal artery to each hypogastric artery length ≥100mm;
• Common iliac artery lumen diameter between 9 and 35mm;
• Distal iliac artery seal zone with length of ≥10mm and diameter range of 9 to 25mm;
• Ability to preserve at least one hypogastric artery.
• Ratio of maximum aortic aneurysm diameter to maximum aortic blood lumen diameter \<1.40

You may not qualify if:

• A patient who meets none of the following criteria potentially may be included in the study:
• Life expectancy \<2 years as judged by the Investigator;
• Psychiatric or other condition that may interfere with the study;
• Participating in another clinical study;
• Known allergy or contraindication to any device material;
• Coagulopathy or uncontrolled bleeding disorder;
• Ruptured, leaking or mycotic aneurysm;
• Serum creatinine (S-Cr) level \>2.0 mg/dL;
• CVA or MI within three months of enrollment/treatment;
• Aneurysmal disease of the descending thoracic aorta;
• Clinically significant mural thrombus within the proximal landing zone (minimum 10mm) of the infrarenal non-aneurysmal neck (\>5mm thickness over \>50% circumference);
• Connective tissue diseases (e.g., Marfan Syndrome);
• Unsuitable vascular anatomy that may interfere with device introduction or deployment;
• Pregnant (female of childbearing potential only).

Sponsors & Collaborators

• Endologix: lead

Study Sites (27)

Valley Vascular Consultants

Huntsville, Alabama, 35801, United States

Location

Regents of the University of California (UCLA)

Los Angeles, California, 90095, United States

Location

Veterans Medical Research Foundation

San Diego, California, 92161, United States

Location

UC Health-Memorial Hospital

Colorado Springs, Colorado, 80909, United States

Location

MedStar Health Research Institute

Washington D.C., District of Columbia, 20010, United States

Location

Miami Cardiac & Vascular Institute (MCVI)

Miami, Florida, 33176, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Coastal Vascular & Interventional

Pensacola, Florida, 32503, United States

Location

Christie Clinic

Champaign, Illinois, 61820, United States

Location

AMITA Health

Elk Grove Village, Illinois, 60007, United States

Location

St. Vincent Heart Center of Indiana

Indianapolis, Indiana, 46290, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

McLaren Bay Region

Bay City, Michigan, 48708, United States

Location

Midwest Aortic & Vascular Institute

Kansas City, Missouri, 64116, United States

Location

The Cooper Health System

Camden, New Jersey, 08103, United States

Location

New Mexico Heart Institute

Albuquerque, New Mexico, 87102, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Northeast Ohio Vascular Assoc (NEOVA)

Willoughby, Ohio, 44095, United States

Location

OU College of Medicine

Tulsa, Oklahoma, 74135, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97213, United States

Location

Palmetto Health- University of South Carolina

Columbia, South Carolina, 29203, United States

Location

Wellmont CVA Heart Institute

Kingsport, Tennessee, 37660, United States

Location

Cardiovascular Surgery Clinic

Memphis, Tennessee, 38120, United States

Location

Inova Research Center

Falls Church, Virginia, 22042, United States

Location

Providence Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

Aspirus Research Institute

Wausau, Wisconsin, 54401, United States

Location

Results Point of Contact

• Title: Tammy Stiver, Manager, Clinical Affairs
• Organization: Endologix LLC

tstiver@endologix.com

+15136731452

Study Officials

• Jeffrey Carpenter, MD

  Cooper Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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. Sites have been chosen with a suitable research infrastructure and physician experience in endovascular aneurysm repair to ensure adequate enrollment. Subjects will be followed procedurally to discharge, at 30 days (primary safety endpoint), six months, one year (primary effectiveness endpoint) and annually thereafter to five years (total follow-up commitment).

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 2, 2017
• Study Start: December 1, 2017
• Primary Completion: June 7, 2022
• Study Completion: August 16, 2025
• Last Updated: March 19, 2025
• Results First Posted: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (27)