Prospective, Multicenter, Single Arm Safety and Effectiveness Trial of the Endologix Fenestrated Stent Graft System for the Endovascular Repair of Juxtarenal/Pararenal (JAA/PAA) Aneurysms
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Abdominal Aortic Aneurysm
- Sponsor
- Endologix
- Enrollment
- 76
- Locations
- 22
- Primary Endpoint
- Safety- Number of Major Adverse Events at 30 Days
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this trial is to determine if the Ventana Fenestrated Stent Graft System is safe and effective for the endovascular repair of juxtarenal or pararenal aortic aneurysms.
Detailed Description
Study Objectives The objective of protocol CP-0004 is to study the safety and effectiveness of the Endologix Fenestrated System in the endovascular treatment of patients with juxtarenal and/or pararenal aortic aneurysms. Study Design This clinical study is a prospective, non-randomized, multicenter study. The first patient enrolled at each site is designated as a 'Roll-In' group patient. Subsequently, enrolled patients are designated as 'Trial' group patients for primary endpoint analysis. Primary Endpoint The primary safety endpoint is defined as the incidence of Major Adverse Events‡ (MAEs) within 30 days. The primary study effectiveness endpoint is Treatment Success at 1-year. This is defined as procedural technical success and the absence of aneurysm rupture; conversion to open surgical repair; Type I endoleak after 30 days; Type III endoleak; clinically significant migration; aneurysm enlargement; or secondary intervention for resolution of endoleak, limb occlusion, migration, aneurysm sac expansion and/or a device defect.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female at least 18 years old;
- •Informed consent understood and signed and patient agrees to all follow-up visits;
- •Have aortic aneurysm with maximum diameter ≥5.5cm, or between 4.5 and 5.5cm and rapidly expanding (\>0.5cm in six months), or \>50% larger than the normal aortic diameter
- •Anatomically eligible for the Bifurcated System per the FDA-approved indications for use (IFU) and for the Fenestrated Stent Graft System:
- •Adequate iliac/femoral access compatible with the required delivery systems
- •Non-aneurysmal infrarenal aortic neck \<15mm in length;
- •Most caudal renal artery to aortoiliac bifurcation length ≥70mm
- •SMA to aortoiliac bifurcation length ≥90mm;
- •Proximal non-aneurysmal aortic neck below the SMA with: diameter 18 to 34 mm; length ≥15 mm; angle ≤60° to the aneurysm sac;
- •Angle ≤60° (clock face) between the SMA and CA
Exclusion Criteria
- •Life expectancy \<2 years as judged by the investigator;
- •Psychiatric or other condition that may interfere with the study;
- •Participating in the enrollment or 30-day follow-up phase of another clinical study;
- •Known allergy to any device component;
- •Coagulopathy or uncontrolled bleeding disorder;
- •Contraindication to contrast media or anticoagulants;
- •Ruptured, leaking, or mycotic aneurysm;
- •Aortic dissection
- •Serum creatinine (S-Cr) level \>2.0 mg/dL;
- •Traumatic vascular injury;
Outcomes
Primary Outcomes
Safety- Number of Major Adverse Events at 30 Days
Time Frame: 30 Days
Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss \>1000cc
Effectiveness
Time Frame: 1 Year
1. Treatment Success is defined as Procedural technical success and absence of aneurysm rupture, conversion to open repair, Type I endoleak after 30 days, Type III endoleak, clinically significant migration; aneurysm enlargement; or secondary intervention for resolution of endoleak, limb occlusion, migration, aneurysm sac expansion and/or a device defect. 2. Procedural Technical Success is defined as a subject with successful implant. 3. Clinically Significant Device Migration: Core Lab reported aortic stent graft movement \>10mm 4. Type I/III/IV Endoleak: Core Lab reported endoleak: between the endograft and the vessel either at the proximal attachment point (Type IA), or at the distal attachment point (Type IB), or between endograft components (Type III) or transgraft (Type IV). 5. Type II Endoleak: Core Lab reported endoleak emanating from a patent collateral vessel (e.g., inferior mesenteric artery, lumbar artery).
Secondary Outcomes
- Time to Hospital Discharge(Hospital Discharge (Post-Procedure))
- Clinical Utility Outcomes(At the time of the procedure)
- Safety- Number of Major Adverse Events > 30 Days to 5 Years(>30 Days to 5 Years)
- Renal Dysfunction(Discharge to 5 Years)
- Time in ICU(In-Hospital)
- Device Integrity(30 Days to 5 Years)
- Aneurysm Sac Morphology(30 Days to 5 Years)
- Endoleaks(30 Days to 5 Years)
- Aneurysm Sac Diameter(30 Days to 5 Years)
- Device Patency(30 Days to 5 Years)