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Pilot Study of the Endologix Fenestrated Stent Graft System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01437215
Recruitment Status : Unknown
Verified June 2013 by Endologix.
Recruitment status was:  Active, not recruiting
First Posted : September 20, 2011
Last Update Posted : June 6, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Juxtarenal Aortic Aneurysm Pararenal Aortic Aneurysm Device: Ventana Fenestrated Stent Graft System Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Multicenter, Single Arm Feasibility and Initial Safety Study of the Endologix Fenestrated Stent Graft System for the Endovascular Repair of Juxtarenal/Pararenal (JAA/PAA) Aneurysms
Study Start Date : November 2010
Primary Completion Date : September 2011
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Fenestrated Endografting Device: Ventana Fenestrated Stent Graft System
Endovascular repair of juxtarenal or pararenal aortic aneurysm

Outcome Measures

Primary Outcome Measures :
  1. Safety [ Time Frame: 30 Days ]
    Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss >1000cc

  2. Feasibility [ Time Frame: 30 Days ]
    Procedural Success with aortic/fenestrated and renal stent graft patency and absence of Type I/III endoleak or migration

Secondary Outcome Measures :
  1. Safety [ Time Frame: >30 Days to 5 Years ]
    Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss >1000cc

  2. Adverse Events [ Time Frame: Procedurally to 5 Years ]
    All adverse events, whether serious or non-serious

  3. Distal Blood Flow [ Time Frame: Discharge to 5 Years ]
    Ankle-brachial index measurements

  4. Renal Dysfunction [ Time Frame: Discharge to 5 Years ]
    eGFR reduction >30% from baseline

  5. Device Performance [ Time Frame: 30 Days to 5 Years ]
    Aortic, fenestrated, and renal stent graft integrity and patency; migration; endoleak; and aneurysm sac morphology

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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;
  • 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 (female patient of childbearing potential only)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01437215

Pontificia Universidad Católica de Chile
Santiago, Chile
New Zealand
Auckland City Hospital
Auckland, New Zealand
Sponsors and Collaborators
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Endologix
ClinicalTrials.gov Identifier: NCT01437215     History of Changes
Other Study ID Numbers: CP-0002
First Posted: September 20, 2011    Key Record Dates
Last Update Posted: June 6, 2013
Last Verified: June 2013

Keywords provided by Endologix:
renal stent

Additional relevant MeSH terms:
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases