Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03298477
Recruitment Status : Active, not recruiting
First Posted : October 2, 2017
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Endologix

Tracking Information
First Submitted Date  ICMJE September 27, 2017
First Posted Date  ICMJE October 2, 2017
Last Update Posted Date November 9, 2020
Actual Study Start Date  ICMJE December 1, 2017
Actual Primary Completion Date March 9, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE Abdominal Aortic Aneurysm Without Rupture
Intervention  ICMJE Device: Nellix® System
Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System
Study Arms  ICMJE Single Arm
Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System
Intervention: Device: Nellix® System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 20, 2020)
98
Original Estimated Enrollment  ICMJE
 (submitted: September 27, 2017)
90
Estimated Study Completion Date  ICMJE March 9, 2025
Actual Primary Completion Date March 9, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03298477
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Endologix
Study Sponsor  ICMJE Endologix
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffrey Carpenter, MD Cooper Hospital
PRS Account Endologix
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP