Aortic Aneurysm, Abdominal
Conditions
Keywords
Aortic aneurysm, Abdominal aorta, Stent graft, Aneurysm, Vascular Diseases, Cardiovascular Diseases
Brief 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.
Detailed 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.
Interventions
DEVICEGORE® 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.
Sponsors
W.L.Gore & Associates
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Free From Primary Safety Endpoint Event | 30 Days | 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) |
| Number of Subjects With Device Treatment Success | 12 Months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Type II Endoleak | 5 years | 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) |
| Number of Subjects With Aneurysm-related Mortality | 5 years | 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) |
| Number of Subjects With Significant Index Procedure Blood Loss | Procedure Day | Defined as estimated blood loss recorded during the endovascular procedure \> 1000 mL |
| Number of Subjects With Type IV Endoleak | 5 years | Defined as Endoleak of whole blood through the graft fabric (Graft Porosity). (assessed by independent 3rd party imaging laboratory) |
| Median Hospital Stay | Through initial hospital discharge | Defined as time to discharge for initial procedural hospitalization |
| Median Index Procedure Time | Procedure Day | Defined as time from first arterial access in the groin to the closure of the final access vessel |
| Number of Subjects With Severe Stroke | 5 years | Defined as stroke resulting in severe impairment or fatal outcome (Adjudicated by independent Clinical Events Committee) |
| Number of Subjects With Severe Myocardial Infarction | 5 years | Defined as myocardial Infarction resulting in severe hemodynamic dysfunction necessitating resuscitation, cardiac arrest, or fatal outcome. (Adjudicated by independent Clinical Events Committee) |
| Number of Subjects With Severe Bowel Ischemia | 5 years | Defined as bowel Ischemia resulting in bowel resection or fatal outcome (Adjudicated by independent Clinical Events Committee) |
| Number of Subjects With Severe Paraplegia | 5 years | Paraplegia resulting in major permanent deficit (Adjudicated by independent Clinical Events Committee) |
| Number of Subject Deaths | 5 years | Defined as death of any cause (all-cause mortality) |
| Number of Subjects With Reintervention | 5 years | Defined as an adverse event treatment performed to either treat the abdominal aneurysm and/or device-related complication (Adjudicated by independent Clinical Events Committee) |
| Number of Subjects With Severe Respiratory Failure | 5 years | 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) |
| Number of Subjects With Thromboembolic Events (Including Limb Occlusion and Distal Embolic Events) | 5 years | 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) |
| Number of Subjects With Type I Endoleak | 5 years | 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) |
| Number of Subjects With Type III Endoleak | 5 years | 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) |
| Number of Subjects With Migration | 5 years | Defined as prosthesis and/or intercomponent migration (10 mm or more) relative to post-operative baseline (assessed by independent 3rd party imaging laboratory) |
| Median Procedural Blood Loss (mL) | Procedure Day | Median blood loss at index procedure |
| Number of Subjects With AAA Enlargement ≥5 mm | 5 years | Defined as AAA enlargement ≥5 mm (with or without reintervention) relative to post-operative baseline (assessed by independent 3rd party imaging laboratory) |
| Number of Subjects With Abdominal Aortic Aneurysm Rupture | 5 years | Defined as rupture in the treated segment of the aorta verified with direct observation or CT scan |
| Number of Subjects With Conversion to Open Repair | 5 years | Defined as open surgical abdominal aneurysm repair necessitating the explant of the stent-graft and abdominal aortic reconstruction (Adjudicated by independent Clinical Events Committee) |
| Technical Success | Procedure Day | 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 |
| Number of Subjects With Severe Renal Failure | 5 years | Defined as renal failure resulting in permanent dialysis, transplant, or fatal outcome (Adjudicated by independent Clinical Events Committee) |
| Number of Subjects With Stent Fracture | 5 years | Defined as fracture of the wire used to construct the stent (assessed by independent 3rd party imaging laboratory) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Short Neck Substudy Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation ≤ 60˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis. | 80 |
| High Neck Angulation Substudy Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation \> 60˚ and ≤ 90˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis. | 95 |
| Total | 175 |
Baseline characteristics
| Characteristic | Short Neck Substudy | Total | High Neck Angulation Substudy |
|---|---|---|---|
| Age, Continuous | 73 years | 74 years | 74 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) White | 75 Participants | 162 Participants | 87 Participants |
| Region of Enrollment United States | 80 participants | 175 participants | 95 participants |
| Sex: Female, Male Female | 9 Participants | 33 Participants | 24 Participants |
| Sex: Female, Male Male | 71 Participants | 142 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 15 / 80 | 25 / 95 |
| other Total, other adverse events | 32 / 80 | 48 / 95 |
| serious Total, serious adverse events | 48 / 80 | 57 / 95 |
Outcome results
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)
Time frame: 30 Days
Population: This population consists of subjects with a physical exam follow-up visit at or after 30 days following CEXC device implant procedure. Additionally, any subjects with an eligible safety event, even if they did not complete a follow-up visit at or after 30 days following implant procedure, were included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Short Neck Substudy | Number of Subjects Free From Primary Safety Endpoint Event | 79 Participants |
| High Neck Angulation Substudy | Number of Subjects Free From Primary Safety Endpoint Event | 89 Participants |
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
Time frame: 12 Months
Population: This population consists of subjects with both a post-op contrast-enhanced CT (CTA) and a 12-Month CTA. Additionally, any subjects with an eligible effectiveness event, even if they did not complete the necessary follow-up visit or imaging to otherwise be included in the population, were included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Short Neck Substudy | Number of Subjects With Device Treatment Success | 65 Participants |
| High Neck Angulation Substudy | Number of Subjects With Device Treatment Success | 73 Participants |
Secondary
Median Hospital Stay
Defined as time to discharge for initial procedural hospitalization
Time frame: Through initial hospital discharge
Population: All enrolled subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Short Neck Substudy | Median Hospital Stay | 1.0 days |
| High Neck Angulation Substudy | Median Hospital Stay | 1.0 days |
Secondary
Median Index Procedure Time
Defined as time from first arterial access in the groin to the closure of the final access vessel
Time frame: Procedure Day
Population: All enrolled subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Short Neck Substudy | Median Index Procedure Time | 84.0 minutes |
| High Neck Angulation Substudy | Median Index Procedure Time | 110 minutes |
Secondary
Median Procedural Blood Loss (mL)
Median blood loss at index procedure
Time frame: Procedure Day
Population: Number of subjects with non-missing blood loss
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Short Neck Substudy | Median Procedural Blood Loss (mL) | 50 mL |
| High Neck Angulation Substudy | Median Procedural Blood Loss (mL) | 50 mL |
Secondary
Number of Subject Deaths
Defined as death of any cause (all-cause mortality)
Time frame: 5 years
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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 5 years
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)
Time frame: 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)
Time frame: 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)
Time frame: 5 years
Secondary
Number of Subjects With Severe Paraplegia
Paraplegia resulting in major permanent deficit (Adjudicated by independent Clinical Events Committee)
Time frame: 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)
Time frame: 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)
Time frame: 5 years
Secondary
Number of Subjects With Severe Stroke
Defined as stroke resulting in severe impairment or fatal outcome (Adjudicated by independent Clinical Events Committee)
Time frame: 5 years
Secondary
Number of Subjects With Significant Index Procedure Blood Loss
Defined as estimated blood loss recorded during the endovascular procedure \> 1000 mL
Time frame: Procedure Day
Population: Subjects with non-missing procedural blood loss
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Short Neck Substudy | Number of Subjects With Significant Index Procedure Blood Loss | 0 Participants |
| High Neck Angulation Substudy | Number of Subjects With Significant Index Procedure Blood Loss | 3 Participants |
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 5 years
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)
Time frame: 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
Time frame: Procedure Day
Population: All enrolled subjects
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Short Neck Substudy | Technical Success | 80 Participants |
| High Neck Angulation Substudy | Technical Success | 93 Participants |