NCT01437215

Brief Summary

The purpose of this study is to determine whether the Endologix fenestrated stent graft system is safe and feasible in the endovascular repair of juxtarenal or pararenal aortic aneurysm.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2010

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2011

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2016

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

September 17, 2011

Last Update Submit

February 15, 2024

Conditions

Juxtarenal Aortic AneurysmPararenal Aortic Aneurysm

Keywords

aneurysmrenal stentjuxtarenalpararenal

Outcome Measures

Primary Outcomes (2)

  • Safety - Number of Major Adverse Events (MAEs)

    Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss \>1000cc

    30 Days

  • Feasibility- Number of subjects with procedural success (stent graft patency) and absence of type I/III endoleaks or migration

    Procedural Success with aortic/fenestrated and renal stent graft patency and absence of Type I/III endoleak or migration

    30 Days

Secondary Outcomes (5)

  • Safety - Number of Major Adverse Events (MAEs)

    >30 Days to 5 Years

  • Adverse Events

    Procedurally to 5 Years

  • Distal Blood Flow

    Discharge to 5 Years

  • Renal Dysfunction

    Discharge to 5 Years

  • Device Performance

    30 Days to 5 Years

Study Arms (1)

Fenestrated Endografting

EXPERIMENTAL
Device: Ventana Fenestrated Stent Graft System

Interventions

Ventana Fenestrated Stent Graft SystemDEVICE

Endovascular repair of juxtarenal or pararenal aortic aneurysm

Fenestrated Endografting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent understood and signed and pt agrees to all follow-up visits;
  • Abdominal aortic aneurysm with diameter ≥5cm or ≥4cm which has increased by 0.5cm or more in the past six months
  • 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 at least 70mm
  • Proximal non-aneurysmal aortic neck below the SMA with: diameter 18 to 34 mm; length at least 15 mm; angle (clock face) \<60° to the aneurysm sac;
  • Angle \<60° (clock face) between the SMA and celiac artery
  • Renal arteries both distal to the SMA by 0-35mm, within 30mm of each other axially, with 4 to 8mm lumen diameter, and with clockface angle of 90° to 210° to each other
  • Iliac anatomy suitable for commercial bifurcated stent graft;
  • Minimum 3cm overlap achievable between fenestrated and bifurcated stent grafts

You may not qualify if:

  • Life expectancy \<1 year 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, dissecting, or mycotic aneurysm;
  • 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 or myocardial infarction;
  • Prior renal transplant;
  • Length of either renal artery to be stented \<13mm;
  • Significant occlusive disease or calcification of either renal artery;
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pontificia Universidad Católica de Chile

Santiago, Chile

Location

Auckland City Hospital

Auckland, New Zealand

Location

Related Publications (1)

  • Holden A, Mertens R, Hill A, Marine L, Clair DG. Initial experience with the Ventana fenestrated system for endovascular repair of juxtarenal and pararenal aortic aneurysms. J Vasc Surg. 2013 May;57(5):1235-45. doi: 10.1016/j.jvs.2012.10.125. Epub 2013 Mar 5.

    PMID: 23466185DERIVED

MeSH Terms

Conditions

Aneurysm

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2011

First Posted

September 20, 2011

Study Start

November 2, 2010

Primary Completion

September 1, 2011

Study Completion

July 28, 2016

Last Updated

February 16, 2024

Record last verified: 2024-02

Locations

CL(1)NZ(1)