Expanding Patient Applicability With Polymer Sealing Ovation Alto Stent Graft Investigational Device Exemption (IDE) Study

Aortic Aneurysm, Abdominal Clinical Trial

— ELEVATE  

Official title:

Expanding Patient Applicability With Polymer Sealing Ovation Alto Stent Graft Investigational Device Exemption (IDE) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02949297
• Other study ID #: 771-0013
• Status: Completed
• Phase: N/A
• Start date: March 30, 2017
• Est. completion date: March 6, 2019

Study information

• Verified date: November 2021
• Source: Endologix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective clinical evaluation of the effectiveness of the Ovation Alto Abdominal Stent Graft System when used in the treatment of subjects with abdominal aortic aneurysm (AAA).

Description:

A prospective clinical evaluation of the effectiveness of the Ovation Alto Abdominal Stent Graft System when used in the treatment of subjects with abdominal aortic aneurysm (AAA). The primary objective is to evaluate treatment success at 12 months with the Ovation Alto Abdominal Stent Graft system. The study will have up to 16 sites, and up to 75 patients based on attrition rates. The follow-up intervals will be at 1, 6, and 12 months following initial implant procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 6, 2019
• Est. primary completion date: March 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria include:

1. Patient has adequate iliac/femoral access compatible with the required delivery systems.

2. Patient has non-aneurysmal proximal aortic neck.

3. Patient has non-aneurysmal distal iliac landing zone.

Exclusion Criteria include:

1. Patient has dissecting aneurysm.

2. Patient has acutely ruptured aneurysm.

3. Patient has need for emergent surgery.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• Ovation Alto Abdominal Stent Graft System
Repair of Abdominal Aortic Aneurysm with Ovation Alto Abdominal Stent Graft System

Locations

Country	Name	City	State
United States	New Mexico Heart Institute	Albuquerque	New Mexico
United States	Mission Hospital	Asheville	North Carolina
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University at Buffalo Clinical Translational Research Center/Kaleida Health/GVI/Buffalo General Medical Center	Buffalo	New York
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Baylor St. Luke's Medical Center	Houston	Texas
United States	Wellmont CVA Heart Institute	Kingsport	Tennessee
United States	Abrazo Arizona Heart Hospital	Phoenix	Arizona
United States	VA San Diego	San Diego	California
United States	Swedish Heart and Vascular Research	Seattle	Washington
United States	North Central Heart	Sioux Falls	South Dakota
United States	Carle Foundation Hospital	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Endologix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Treatment Success	Treatment success is defined as technical success, freedom from type I and III endoleaks at 12 months, freedom from stent graft migration > 10m at 12 months compared to 1 month baseline, freedom from AAA enlargement >5mm at 12 months (compared to 1-month baseline, freedom from AAA rupture through 12 months, freedom from conversion to open repair through 12 months, stent graft stenosis, occlusion or kink requiring secondary intervention through 12 months, thromboembolic event attributable to stent graft requiring secondary intervention through 12 months, stent fracture requiring secondary intervention through 12 months.	12 months
Secondary	Event Rates for Endoleaks	Endoleak is defined by the persistence of blood flow outside the lumen of the endovascular graft but within the aneurysm sac and can be classified as: Type I - Ineffective seal at either the proximal or distal sealing zones; Type IA - Ineffective seal at the proximal sealing zone; Type IB - Ineffective seal at the distal sealing zone; Type II - Retrograde blood flow from lumbar arteries, the inferior mesenteric artery, or other collateral vessels into the aneurysm sac; Type III - A leak caused by fabric tears or disruption, component disconnection, or graft disintegration; Type IIIA - Junctional leak or component disconnection; Type IIIB - Midgraft hole; Type IV - Blood flow through an intact fabric.; Unknown endoleak - Endoleak present but unable to assess type Endoleak will only be evaluated as an adverse event or serious adverse event if it is present at the 30-day follow-up visit or if a post-index procedure re-intervention occurs.	1 month, 6 months, 12 months
Secondary	Number of Participants With Stent Graft Migration > 10mm	any change of stent graft migration (movement) greater than 10mm	6 months, 12 months
Secondary	Number of Participants With AAA Enlargement > 5mm	Change in aneurysm diameter greater than 5mm	6 months, 12 months
Secondary	Number of Participants With AAA Rupture	A tear in the abdominal aorta that can result in serious internal bleeding.	30 day, Day 31-365
Secondary	Number of Participants With Conversion to Open Repair	conversion to open abdominal surgery to repair AAA	30 day, Day 31-365
Secondary	Number of Secondary Interventions	Intervention occurring after index procedure and having to do with device or AAA.	30 days, Day 31-365
Secondary	Number of Participants With AAA-related Mortality	death caused by or related to AAA	1 month, Day 31-365
Secondary	Device-related Adverse Events (AEs)	Device-Related: Event is caused or contributed by any component of the device during delivery, deployment or while the device is in situ post-operatively	30 days, Day 31-365
Secondary	Major Adverse Events	Major adverse events (MAE) are defined as any one of the following events: Death; Myocardial Infarction; Stroke (excludes TIA); Renal Failure (excludes renal insufficiency); Respiratory Failure (excludes chronic obstructive pulmonary disease (COPD) or pulmonary complications); Paralysis (excludes paraparesis); Bowel Ischemia; Procedural Blood Loss (=1,000 cc)	1 year
Secondary	Number of Participants With Other Stent Graft Finding (Includes Kinking and Stent Compression)	The integrity of the stent graft is evaluated by the Independent Core Lab via abdominal X-rays at regularly scheduled follow-up visits. Any fractured stents, and any other issues compromising the integrity of the stent graft will be reported.	1 month, 6 months, 12 months
Secondary	Number of Participants With Stent Fracture	The integrity of the stent graft is evaluated by the Independent Core Lab via abdominal X-rays at regularly scheduled follow-up visits. Any fractured stents, and any other issues compromising the integrity of the stent graft will be reported.	1 month, 6 months, 12 months
Secondary	Adverse Events (Serious and Non-serious)	An adverse event is any new, undesirable medical occurrence or change (worsening) of a pre-existing condition that occurs in a subject, whether or not considered to be associated with the product	30 days, Day 31-365
Secondary	Procedure-related Adverse Event	Procedure-Related event is caused or contributed by the initial study device implantation (index) procedure, up to 30 days, unless a different etiology can be identified	30 days, Day 31-365
Secondary	Serious Adverse Event	A serious adverse event (SAE) defined as one that suggests a significant hazard or side effect, regardless of the investigator or Sponsor's opinion on the relationship to the investigational product. This includes, but may not be limited to, any event that: Is fatal; Is life-threatening; Requires or prolongs (>48 hours) inpatient hospitalization; Is a persistent or significant disability or incapacity; Is considered an important medical event	30 Days, Day31-365)

External Links

•   Endologix Website