Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms

Aortic Aneurysm, Abdominal Clinical Trial

Official title:

Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02489539
• Other study ID #: AAA 13-03 (1)
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 19, 2017
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal aorta. Performance of the GORE® EXCLUDER® Conformable AAA Endoprosthesis will be judged by separate performance goals.

Description:

The study design is a prospective, nonrandomized, international, multicenter study comprised of two parallel substudies. The total subject population is 175 subjects with 80 subjects assigned to the Short Neck Substudy and 95 subjects to the High Neck Angulation Substudy. This clinical study will include up to fifty-six sites in the US. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams and contrast-enhanced computed tomography (CT) scans at specific, protocol-defined intervals for a period of five years following the GORE® EXCLUDER® Conformable AAA Endoprosthesis implant. Each Substudy will be evaluated and reported independently from each other according to the Safety and Effectiveness Endpoints. No comparative analyses between these substudies are planned.

Other known NCT identifiers

• NCT02489552

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 175
• Est. completion date: December 31, 2027
• Est. primary completion date: May 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. AAA meeting any of the following criteria:

• Maximum diameter =50 mm
• Rapid growth (>5 mm in a 6 month period)
• Non-ruptured AAA presenting with clinical symptoms

2. Adequate anatomy to receive the GORE® EXCLUDER® Conformable AAA Endoprosthesis,

including:

• Adequate iliac / femoral access
• Infrarenal aortic neck diameter 16-32 mm
• Infrarenal aortic neck length =10 mm
• Aortic neck angle = 90°
• Distal iliac artery seal zone =10 mm
• Iliac artery diameter 8-25 mm

3. An Informed Consent Form (ICF) signed by Subject

4. Male or infertile female

5. Able to comply with Protocol requirements including following-up

6. Life expectancy > 2 years

7. Age = 21 years

Exclusion Criteria:

1. Mycotic or ruptured aneurysm

2. Known concomitant thoracic aortic aneurysm which requires surgical intervention

3. Renal insufficiency defined as creatinine > 2.5 mg/dL or patient undergoing dialysis

4. New York Heart Association (NYHA) class IV

5. Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s)

6. Severely tortuous or stenotic iliac and / or femoral arteries

7. Patient has body habitus or other medical condition which prevents adequate delineation of the aorta

8. Participating in another investigational device or drug study within 1 year of treatment

9. Systemic infection which may increase the risk of endovascular graft infection

10. Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome

11. Planned concomitant surgical procedure or major surgery within 30 days of treatment date

12. Known history of drug abuse

13. Known sensitivities or allergies to the device materials

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• GORE® EXCLUDER® Conformable AAA Endoprosthesis
Endovascular Aneurysm repair (EVAR) is a minimally invasive procedure designed to exclude an aneurysmal segment of the aorta from blood circulation. The EVAR procedure involves delivery of a stent- graft compressed onto a catheter to an aneurysmal segment of the aorta from a remote access site, generally the femoral artery. Arterial access may be done by either percutaneous or cut-down technique.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Mission Hospital	Asheville	North Carolina
United States	Emory University	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Maimonides Medical Center	Brooklyn	New York
United States	Research Foundation SUNY Buffalo	Buffalo	New York
United States	CAMC Health Education and Research Institute, Inc.	Charleston	West Virginia
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Good Samaritan Hospital-Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio Health Research Institute	Columbus	Ohio
United States	Essentia Institute of Rural Health	Duluth	Minnesota
United States	Duke University Medical Center	Durham	North Carolina
United States	Spectrum Health System	Grand Rapids	Michigan
United States	Moses Cone Memorial Hospital	Greensboro	North Carolina
United States	Prisma Health-Upstate	Greenville	South Carolina
United States	Texas Heart Institute/Baylor St. Luke's Medical Center	Houston	Texas
United States	The Methodist Hospital - Houston	Houston	Texas
United States	University of Iowa Hospitals & Clinic	Iowa City	Iowa
United States	River City Clinical Research	Jacksonville	Florida
United States	University of Tennessee	Knoxville	Tennessee
United States	The Hitchcock Foundation	Lebanon	New Hampshire
United States	University of Southern California	Los Angeles	California
United States	University of Wisconsin System	Madison	Wisconsin
United States	Vascular Surgical Associates, PC	Marietta	Georgia
United States	Loyola University - Chicago	Maywood	Illinois
United States	Baptist Cardiac and Vascular Institute	Miami	Florida
United States	Aurora Health Care, Metro Inc.	Milwaukee	Wisconsin
United States	Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	AHA Hospital Corp.	Morristown	New Jersey
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Sentara Medical Group	Norfolk	Virginia
United States	Oklahoma Heart Hospital Research Foundation	Oklahoma City	Oklahoma
United States	Florida Hospital	Orlando	Florida
United States	Mayo Clinic Arizona	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Minneapolis Radiology and Vascular Research Foundation	Plymouth	Minnesota
United States	Rhode Island Hospital	Providence	Rhode Island
United States	NC Heart and Vascular Research, LLC	Raleigh	North Carolina
United States	Mayo Clinic - Rochester	Rochester	Minnesota
United States	Mercy Research	Saint Louis	Missouri
United States	Washington University School of Medicine - St. Louis	Saint Louis	Missouri
United States	Sarasota Vascular Specialists	Sarasota	Florida
United States	North Central Heart Institute, Ltd.	Sioux Falls	South Dakota
United States	Sanford Clinic - Clinic Research	Sioux Falls	South Dakota
United States	Southern Illinois University	Springfield	Illinois
United States	Leland Stanford Junior University	Stanford	California
United States	Staten Island University Hospital	Staten Island	New York
United States	Inova Cardiology-Fairfax	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Free From Primary Safety Endpoint Event	The primary safety endpoint event includes a composite of the following: Death; Stroke; Myocardial Infarction; Bowel Ischemia; Paraplegia; Respiratory Failure; Renal Failure; Procedural Blood Loss > 1000 mL; Thromboembolic events (including limb occlusion and distal embolic events)	30 Days
Primary	Number of Subjects With Device Treatment Success	The Primary Effectiveness Endpoint of device treatment success is a composite of technical success (successful access and deployment of all required GORE® EXCLUDER® Conformable AAA Endoprosthesis components) and freedom from: Type I endoleak in the 12 month window; Type III endoleak in the 12 month window; Migration (10 mm or more) at the 12 month window (relative to post-operative baseline); AAA enlargement =5 mm with or without intervention at the 12 month window (relative to post-operative baseline); AAA rupture through the 12 month window; Conversion to open repair through the 12 month window	12 Months
Secondary	Number of Subjects With Reintervention	Defined as an adverse event treatment performed to either treat the abdominal aneurysm and/or device-related complication (Adjudicated by independent Clinical Events Committee)	5 years
Secondary	Number of Subjects With Stent Fracture	Defined as fracture of the wire used to construct the stent (assessed by independent 3rd party imaging laboratory)	5 years
Secondary	Number of Subjects With Type II Endoleak	Defined as an endoleak arising from a patent branch vessel perfusing the aneurysm, e.g., lumbar or inferior mesenteric branch. (assessed by independent 3rd party imaging laboratory)	5 years
Secondary	Number of Subjects With Aneurysm-related Mortality	Defined as a composite of the following: death within 30 days or in hospital from initial procedure, death due to rupture of the originally treated aneurysm and death within 30 days or in hospital following a procedure to treat the originally treated aneurysm. (Adjudicated by independent Clinical Events Committee)	5 years
Secondary	Number of Subjects With Significant Index Procedure Blood Loss	Defined as estimated blood loss recorded during the endovascular procedure > 1000 mL	Procedure Day
Secondary	Number of Subjects With Type IV Endoleak	Defined as Endoleak of whole blood through the graft fabric (Graft Porosity). (assessed by independent 3rd party imaging laboratory)	5 years
Secondary	Median Hospital Stay	Defined as time to discharge for initial procedural hospitalization	Through initial hospital discharge
Secondary	Median Index Procedure Time	Defined as time from first arterial access in the groin to the closure of the final access vessel	Procedure Day
Secondary	Number of Subjects With Severe Stroke	Defined as stroke resulting in severe impairment or fatal outcome (Adjudicated by independent Clinical Events Committee)	5 years
Secondary	Number of Subjects With Severe Myocardial Infarction	Defined as myocardial Infarction resulting in severe hemodynamic dysfunction necessitating resuscitation, cardiac arrest, or fatal outcome. (Adjudicated by independent Clinical Events Committee)	5 years
Secondary	Number of Subjects With Severe Bowel Ischemia	Defined as bowel Ischemia resulting in bowel resection or fatal outcome (Adjudicated by independent Clinical Events Committee)	5 years
Secondary	Number of Subjects With Severe Paraplegia	Paraplegia resulting in major permanent deficit (Adjudicated by independent Clinical Events Committee)	5 years
Secondary	Number of Subject Deaths	Defined as death of any cause (all-cause mortality)	5 years
Secondary	Number of Subjects With Severe Renal Failure	Defined as renal failure resulting in permanent dialysis, transplant, or fatal outcome (Adjudicated by independent Clinical Events Committee)	5 years
Secondary	Number of Subjects With Severe Respiratory Failure	Defined as respiratory failure resulting in prolonged intubation (> 48 hours), tracheostomy, deterioration in pulmonary function, new onset O2 dependence, or fatal outcome (Adjudicated by independent Clinical Events Committee)	5 years
Secondary	Number of Subjects With Thromboembolic Events (Including Limb Occlusion and Distal Embolic Events)	Defined as ischemic events from tissues distal to the device implantation site (lower extremity, buttock, etc.) and that are a direct result of an occlusion within the device or sufficiently debilitating to necessitate bypass, open surgical repair, or limb amputation (Adjudicated by independent Clinical Events Committee)	5 years
Secondary	Number of Subjects With Type I Endoleak	Defined as endoleak arising from the proximal (Type IA) or distal (Type IB) sealing zone of the device perfusing the aneurysm. (assessed by independent 3rd party imaging laboratory)	5 years
Secondary	Number of Subjects With Type III Endoleak	Defined as endoleak arising from the component junction(s) of the prosthesis or due to damage to the graft material (assessed by independent 3rd party imaging laboratory)	5 years
Secondary	Number of Subjects With Migration	Defined as prosthesis and/or intercomponent migration (10 mm or more) relative to post-operative baseline (assessed by independent 3rd party imaging laboratory)	5 years
Secondary	Median Procedural Blood Loss (mL)	Median blood loss at index procedure	Procedure Day
Secondary	Number of Subjects With AAA Enlargement =5 mm	Defined as AAA enlargement =5 mm (with or without reintervention) relative to post-operative baseline (assessed by independent 3rd party imaging laboratory)	5 years
Secondary	Number of Subjects With Abdominal Aortic Aneurysm Rupture	Defined as rupture in the treated segment of the aorta verified with direct observation or CT scan	5 years
Secondary	Number of Subjects With Conversion to Open Repair	Defined as open surgical abdominal aneurysm repair necessitating the explant of the stent-graft and abdominal aortic reconstruction (Adjudicated by independent Clinical Events Committee)	5 years
Secondary	Technical Success	Successful access and deployment of all required CEXC device components, comprised of all the following: Successful access; Successful deployment of Device endoprostheses in the intended anatomical location; Successful removal of all device delivery catheters from the patient; Patent Device components on completion angiography; Absence of Type I or Type III endoleak on completion angiography; Successful access site closure	Procedure Day