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

• Sponsor: Endologix (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03298477
• Collaborator: (none)
• Enrollment: 98
• Locations: 27
• Arm: 1
• Anticipated Duration (Months): 92.5
• Patients Per Site: 3.6
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Aortic Aneurysm Without Rupture	Device: Nellix® System	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 98 participants
• 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).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
• 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)
• Actual Study Start Date: Dec 1, 2017
• Anticipated Primary Completion Date: Aug 17, 2022
• Anticipated Study Completion Date: Aug 16, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: Single Arm Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System	Device: Nellix® System; Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System

Outcome Measures

Primary Outcome Measures

1. Incidence of Major Adverse Events (MAE) [30 days]

   All cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, procedural blood loss >1,000cc

2. Rate of Treatment Success [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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):

6. Adequate iliac/femoral access compatible with the required delivery systems (diameter ≥6 mm);

7. Aneurysm blood lumen diameter ≤60mm;

8. Proximal non-aneurysmal aortic neck: length ≥10mm; diameter 18 to 28mm; angle ≤60° to the aneurysm sac;

9. Most caudal renal artery to each hypogastric artery length ≥100mm;

10. Common iliac artery lumen diameter between 9 and 35mm;

11. Distal iliac artery seal zone with length of ≥10mm and diameter range of 9 to 25mm;

12. Ability to preserve at least one hypogastric artery.

13. 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Valley Vascular Consultants	Huntsville	Alabama	United States	35801
2	Regents of the University of California (UCLA)	Los Angeles	California	United States	90095
3	Veterans Medical Research Foundation	San Diego	California	United States	92161
4	UC Health-Memorial Hospital	Colorado Springs	Colorado	United States	80909
5	MedStar Health Research Institute	Washington	District of Columbia	United States	20010
6	Miami Cardiac & Vascular Institute (MCVI)	Miami	Florida	United States	33176
7	AdventHealth Orlando	Orlando	Florida	United States	32803
8	Coastal Vascular & Interventional	Pensacola	Florida	United States	32503
9	Christie Clinic	Champaign	Illinois	United States	61820
10	AMITA Health	Elk Grove Village	Illinois	United States	60007
11	St. Vincent Heart Center of Indiana	Indianapolis	Indiana	United States	46290
12	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
13	McLaren Bay Region	Bay City	Michigan	United States	48708
14	Midwest Aortic & Vascular Institute	Kansas City	Missouri	United States	64116
15	The Cooper Health System	Camden	New Jersey	United States	08103
16	New Mexico Heart Institute	Albuquerque	New Mexico	United States	87102
17	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
18	Cleveland Clinic	Cleveland	Ohio	United States	44195
19	Northeast Ohio Vascular Assoc (NEOVA)	Willoughby	Ohio	United States	44095
20	OU College of Medicine	Tulsa	Oklahoma	United States	74135
21	Providence St. Vincent Medical Center	Portland	Oregon	United States	97213
22	Palmetto Health- University of South Carolina	Columbia	South Carolina	United States	29203
23	Wellmont CVA Heart Institute	Kingsport	Tennessee	United States	37660
24	Cardiovascular Surgery Clinic	Memphis	Tennessee	United States	38120
25	Inova Research Center	Falls Church	Virginia	United States	22042
26	Providence Sacred Heart Medical Center	Spokane	Washington	United States	99204
27	Aspirus Research Institute	Wausau	Wisconsin	United States	54401

Sponsors and Collaborators

• Endologix

Investigators

• Principal Investigator: Jeffrey Carpenter, MD, Cooper Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Endologix
• ClinicalTrials.gov Identifier: NCT03298477
• Other Study ID Numbers: CP-0008 EVAS2 IDE
• First Posted: Oct 2, 2017
• Last Update Posted: Oct 1, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Rupture

Study Results

No Results Posted as of Oct 1, 2021