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

• ClinicalTrials.gov Identifier: NCT03298477
• Recruitment Status: Active, not recruiting
• First Posted: October 2, 2017
• Last Update Posted: November 9, 2020
• Sponsor: Endologix
• Information provided by (Responsible Party): Endologix

Tracking Information

• First Submitted Date: September 27, 2017
• First Posted Date: October 2, 2017
• Last Update Posted Date: November 9, 2020
• Actual Study Start Date: December 1, 2017
• Actual Primary Completion Date: March 9, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 27, 2017)

• Incidence of Major Adverse Events (MAE) [ Time Frame: 30 days ]
  All cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, procedural blood loss >1,000cc
• Rate of Treatment Success [ Time Frame: 1 year ]
  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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
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).

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Abdominal Aortic Aneurysm Without Rupture

Intervention

Device: Nellix® System

Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System

Study Arms

Single Arm

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

Intervention: Device: Nellix® System

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: May 20, 2020): 98
• Original Estimated Enrollment (submitted: September 27, 2017): 90
• Estimated Study Completion Date: March 9, 2025
• Actual Primary Completion Date: March 9, 2020 (Final data collection date for primary outcome measure)

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03298477
• Other Study ID Numbers: CP-0008 EVAS2 IDE
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Endologix
• Study Sponsor: Endologix
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jeffrey Carpenter, MD; Cooper Hospital

• PRS Account: Endologix
• Verification Date: November 2020