Skip to main content
OpenTrials
Completed

NCT Number: NCT01348828

Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System

The aim of this study is to evaluate the safety and feasibility of the Endologix Fenestrated Stent Graft System for the endovascular repair of juxtarenal or pararenal aortic aneurysms.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universidad Catolica, Santiago, Chile

Loading trial locations.

About this study

The Endologix Fenestrated Stent Graft System that will be used in this study has three components, listed below:

  • Endologix unibody bifurcated stent graft
  • Endologix fenestrated proximal extension stent graft
  • Endologix renal stent graft

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 >= 70
  • SMA to aortoiliac bifurcation length >=90mm
  • Proximal non-aneurysmal aortic neck below the SMA with diameter 18 to 34 mm, length >=15mm and angle <=60° to the aneurysm sac
  • Angle <=60° (clock face) between the SMA and CA
  • Renal arteries both at or below the SMA by <=35mm and within 30mm of each other axially, with 4 to 8mm lumen diameter, and with clockface angle of 90° to 210° to each other
  • Common iliac artery distal fixation site with: distal fixation length >=15mm, with diameter >=10 mm and <=23 mm and angle <=90° to the aortic bifurcation
  • Ability to preserve at least one hypogastric artery

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
  • Active systemic or localized groin infection
  • Connective tissue disease (e.g., Marfan's Syndrome)
  • Recent(within prior three months)cerebrovascular accident
  • Recent(within prior three months)myocardial infarction
  • Prior renal transplant
  • Length of either renal artery to be stented <12mm
  • Significant occlusive disease or calcification of either renal artery (>70%)
  • An essential accessory renal artery
  • Indispensable inferior mesenteric artery
  • Untreated aneurysmal disease of the descending thoracic aorta
  • Clinically significant mural thrombus circumferentially in the suprarenal segment
  • Prior iliac artery stent implanted that may interfere with delivery system introduction
  • Unsuitable vascular anatomy
  • Pregnancy

Treatment and study plan

Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System)

Device

Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System

Other names: Ventana, Xpand

Primary outcomes

  1. Primary Safety Endpoint

    Time frame: 30 days

    Major adverse events defined as:

    • All-cause death
    • Bowel ischemia
    • Myocardial infarction
    • Paraplegia
    • Renal failure
    • Respiratory failure
    • Stroke
    • Blood loss >=1,000cc

Secondary outcomes

  1. Feasibility/Effectiveness

    Time frame: 1 Year

    Successful device delivery and deployment with patency of the renal and aortic endografts without Type I/III endoleak.

    • Treatment Success is defined as procedural technical success with device patency and the absence of type I/III endoleak
    • Procedural Technical Success is defined as a subject with successful implant.
    • Aneurysm Rupture: An aneurysm is a balloon-like bulge of an artery wall. As an aneurysm grows it puts pressure on nearby structures and may eventually rupture.
    • Clinically Significant Device Migration: Core Lab reported aortic stent graft movement >10mm
    • 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).
    • Type II Endoleak: Core Lab reported endoleak emanating from a patent collateral vessel (e.g., inferior mesenteric artery, lumbar artery).

  2. Procedural/In-hospital Evaluations

    Time frame: Procedurally and to hospital discharge

    Fluoroscopy time, Renal Artery Cannulation time and procedure time

  3. Mortality

    Time frame: Procedurally and to 5 Years

    All-cause and aneurysm-related

  4. Major Adverse Events

    Time frame: >30 Days to 5 Years

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

  5. Number of Participants With Renal Dysfunction

    Time frame: 30 Days, 6 Months and Years 1 to 5

    Renal Dysfunction, Renal Dysfunction In subjects with baseline eGFR>=60 and Renal Dysfunction In subjects with baseline eGFR <60

  6. Aneurysm Rupture

    Time frame: Procedurally and to 5 Years

    Internal bleeding or leaking of blood from the aneurysm subsequent to the index procedure

  7. Conversion to Open Repair

    Time frame: Procedurally and to 5 Years

    Open surgical repair of the aortic aneurysm due to unsuccessful delivery or deployment of the stent graft, due to complications or other clinical situations that precluded successful endovascular treatment, or at any time following initial successful endovascular treatment for any reason

  8. Device Integrity

    Time frame: 30 Days, 6 Months, and Years 1 to 5

    Device Migration, Ventana Stent Fracture, Left renal stent fracture, right renal stent fracture, stent Kinking/Compression

  9. Stent Graft Patency

    Time frame: 30 Days, 6 Months, and Years 1 to 5

    Ventana and Bifurcated occlusion, LRA (Left renal artery) occlusion and RRA (right renal artery) occlusion

  10. Aneurysm Diameter Change

    Time frame: 6 Months, and Years 1 to 5

    Change in aneurysm sac diameter - decrease > 5mm, Increase > 5mm, Stable (+/- 5mm) and No growth.

  11. Secondary Procedures

    Time frame: 30 Days, 6 Month and Years 1 to 5

    Non-diagnostic intervention after the index procedure intended to correct or repair an endoleak (device-related: Type I (proximal or distal), Type III, Type IV; non-device related: Type II), device migration, or other device defect.

  12. Procedural/In-hospital Evaluations

    Time frame: Procedurally and to hospital discharge

    Contrast volume and estimated blood loss

  13. Procedural/In-hospital Evaluations

    Time frame: Discharge

    Time to hospital discharge

Sponsors and collaborators

Lead sponsor

Endologix

Industry

Registry information

Official study title

Prospective, Multicenter, Single Arm Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System for the Endovascular Repair of Juxtarenal/Pararenal (JAA/PAA) Aneurysms

Important dates

Study start
2011
Primary completion
2013
Study completion
2018
First posted
May 5, 2011
Registry last updated
Oct 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.