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
  Purpose

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 Intervention Phase
Juxtarenal Aortic Aneurysm
Pararenal Aortic Aneurysm
Device: Ventana Fenestrated Stent Graft System
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Endologix:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 15
Study Start Date: November 2010
Estimated Study Completion Date: August 2016
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fenestrated Endografting Device: Ventana Fenestrated Stent Graft System
Endovascular repair of juxtarenal or pararenal aortic aneurysm

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01437215

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

No publications provided by Endologix

Additional 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
Study First Received: September 17, 2011
Last Updated: June 5, 2013
Health Authority: Chile: Ministry of Health
New Zealand: Minitry of Health

Keywords provided by Endologix:
aneurysm
renal stent
juxtarenal
pararenal

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

ClinicalTrials.gov processed this record on August 20, 2014