Clinical trial NCT03298477: EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Abdominal Aortic Aneurysm Without Rupture
Lead sponsor: Endologix
Sponsor class: INDUSTRY
First posted: 2017-10-02
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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).
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Safety: Major Adverse Events (MAE)
timeFrame: 30 days
measure: Effectiveness: Rate of Treatment Success
timeFrame: 2 year
Secondary outcomes:
measure: Conversions, Death and Ruptures
timeFrame: 2 Years
measure: Device Integrity
timeFrame: 2 Years
measure: Device Performance - Endoleak
timeFrame: 2 Years
measure: DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Avg Size
timeFrame: 2 years
measure: DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Changes in Sac Size Since 01 Month
timeFrame: 2 Years
measure: Secondary Interventions
timeFrame: 2 Years
measure: LABS-RENAL FUNCTION (EGFR)
timeFrame: 2 Years
measure: LABS- RENAL FUNCTION (CREATININE)
timeFrame: 2 Years
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Valley Vascular Consultants
state: Alabama
city: Los Angeles
country: United States
facility: Regents of the University of California (UCLA)
state: California
city: San Diego
country: United States
facility: Veterans Medical Research Foundation
state: California
city: Colorado Springs
country: United States
facility: UC Health-Memorial Hospital
state: Colorado
city: Washington
country: United States
facility: MedStar Health Research Institute
state: District of Columbia
city: Miami
country: United States
facility: Miami Cardiac & Vascular Institute (MCVI)
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Pensacola
country: United States
facility: Coastal Vascular & Interventional
state: Florida
city: Champaign
country: United States
facility: Christie Clinic
state: Illinois
city: Elk Grove Village
country: United States
facility: AMITA Health
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Heart Center of Indiana
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Bay City
country: United States
facility: McLaren Bay Region
state: Michigan
city: Kansas City
country: United States
facility: Midwest Aortic & Vascular Institute
state: Missouri
city: Camden
country: United States
facility: The Cooper Health System
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute
state: New Mexico
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Willoughby
country: United States
facility: Northeast Ohio Vascular Assoc (NEOVA)
state: Ohio
city: Tulsa
country: United States
facility: OU College of Medicine
state: Oklahoma
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Columbia
country: United States
facility: Palmetto Health- University of South Carolina
state: South Carolina
city: Kingsport
country: United States
facility: Wellmont CVA Heart Institute
state: Tennessee
city: Memphis
country: United States
facility: Cardiovascular Surgery Clinic
state: Tennessee
city: Falls Church
country: United States
facility: Inova Research Center
state: Virginia
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center
state: Washington
city: Wausau
country: United States
facility: Aspirus Research Institute
state: Wisconsin
Study officials:
affiliation: Cooper Hospital
name: Jeffrey Carpenter, MD
role: PRINCIPAL_INVESTIGATOR
References: