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Pilot Study of the Endologix Fenestrated Stent Graft System

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Endologix
ClinicalTrials.gov Identifier:
NCT01437215
First received: September 17, 2011
Last updated: June 5, 2013
Last verified: June 2013

September 17, 2011
June 5, 2013
November 2010
September 2011   (final data collection date for primary outcome measure)
  • Safety [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
    Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss >1000cc
  • Feasibility [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
    Procedural Success with aortic/fenestrated and renal stent graft patency and absence of Type I/III endoleak or migration
  • Safety [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
    Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complicationl stroke; blood loss >1000cc
  • Feasibility [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
    Procedural Success with aortic/fenestrated and renal stent graft patency and absence of Type I/III endoleak or migration
Complete list of historical versions of study NCT01437215 on ClinicalTrials.gov Archive Site
  • Safety [ Time Frame: >30 Days to 5 Years ] [ Designated as safety issue: Yes ]
    Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss >1000cc
  • Adverse Events [ Time Frame: Procedurally to 5 Years ] [ Designated as safety issue: Yes ]
    All adverse events, whether serious or non-serious
  • Distal Blood Flow [ Time Frame: Discharge to 5 Years ] [ Designated as safety issue: Yes ]
    Ankle-brachial index measurements
  • Renal Dysfunction [ Time Frame: Discharge to 5 Years ] [ Designated as safety issue: Yes ]
    eGFR reduction >30% from baseline
  • Device Performance [ Time Frame: 30 Days to 5 Years ] [ Designated as safety issue: Yes ]
    Aortic, fenestrated, and renal stent graft integrity and patency; migration; endoleak; and aneurysm sac morphology
  • Safety [ Time Frame: >30 Days to 5 Years ] [ Designated as safety issue: Yes ]
    Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complicationl stroke; blood loss >1000cc
  • Adverse Events [ Time Frame: Procedurally to 5 Years ] [ Designated as safety issue: Yes ]
    All adverse events, whether serious or non-serious
  • Distal Blood Flow [ Time Frame: Discharge to 5 Years ] [ Designated as safety issue: Yes ]
    Ankle-brachial index measurements
  • Renal Dysfunction [ Time Frame: Discharge to 5 Years ] [ Designated as safety issue: Yes ]
    eGFR reduction >30% from baseline
  • Device Performance [ Time Frame: 30 Days to 5 Years ] [ Designated as safety issue: Yes ]
    Aortic, fenestrated, and renal stent graft integrity and patency; migration; endoleak; and aneurysm sac morphology
Not Provided
Not Provided
 
Pilot Study of the Endologix Fenestrated Stent Graft System
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Juxtarenal Aortic Aneurysm
  • Pararenal Aortic Aneurysm
Device: Ventana Fenestrated Stent Graft System
Endovascular repair of juxtarenal or pararenal aortic aneurysm
Experimental: Fenestrated Endografting
Intervention: Device: Ventana Fenestrated Stent Graft System
Holden A, Mertens R, Hill A, Mariné 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
15
August 2016
September 2011   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Chile,   New Zealand
 
NCT01437215
CP-0002
No
Endologix
Endologix
Not Provided
Not Provided
Endologix
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP