Safety and Effectiveness Trial of the Ventana Fenestrated Stent Graft System

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Endologix
ClinicalTrials.gov Identifier:
NCT01491945
First received: October 20, 2011
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

The purpose of this trial is to determine if the Ventana Fenestrated Stent Graft System is safe and effective for the endovascular repair of juxtarenal or pararenal aortic aneurysms.


Condition Intervention Phase
Abdominal Aortic Aneurysm
Device: Ventana Fenestrated Stent Graft System
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Multicenter, Single Arm Safety and Effectiveness Trial 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

  • Effectiveness [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
    Treatment Success=Procedural technical success and absence of aneurysm rupture, conversion to open repair, Type I endoleak after 30 days, Type III endoleak, clinically significant migration; aneurysm enlargement; or secondary intervention for resolution of endoleak, limb occlusion, migration, aneurysm sac expansion and/or a device defect


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

  • 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

  • Clinical Utility Outcomes [ Time Frame: At the time of the procedure ] [ Designated as safety issue: Yes ]
    Clinical Utility Outcomes consists of: anesthesia time; fluoroscopy time; contrast volume; estimated blood loss; % requiring transfusion; procedure time

  • Time in ICU [ Time Frame: In-Hospital ] [ Designated as safety issue: No ]
    Number of hours spent in the intensive care unit (ICU)

  • Time to Hospital Discharge [ Time Frame: Hospital Discharge (Post-Procedure) ] [ Designated as safety issue: No ]
    Number of days from the index procedure to discharge from the hospital.


Estimated Enrollment: 122
Study Start Date: March 2012
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ventana Fenestrated Stent Graft System Device: Ventana Fenestrated Stent Graft System

The Ventana Fenestrated Stent Graft System consists of the following:

bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts


  Eligibility

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

Inclusion Criteria:

  • Male or female at least 18 years old;
  • Informed consent understood and signed and patient agrees to all follow-up visits;
  • Have aortic aneurysm with maximum diameter ≥5.5cm, or between 4.5 and 5.5cm and rapidly expanding (>0.5cm in six months), or >50% larger than the normal aortic diameter
  • Anatomically eligible for the Bifurcated System per the FDA-approved indications for use (IFU) and for the Fenestrated Stent Graft System:

    • 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 ≥70mm
    • SMA to aortoiliac bifurcation length ≥90mm;
    • Proximal non-aneurysmal aortic neck below the SMA with: diameter 18 to 34 mm; length ≥15 mm; angle ≤60° to the aneurysm sac;
    • Angle ≤60° (clock face) between the SMA and CA
    • Renal arteries both distal to the SMA by ≤35mm, within 30mm of each other axially, with 4 to 8mm lumen diameter, and with clock face angle of 90° to 210° to each other .Common iliac artery distal fixation site with: distal fixation length ≥15 mm; ability to preserve at least one hypogastric artery; diameter ≥10 mm and ≤23 mm; angle ≤90° to the aortic bifurcation.
  • The Endologix Fenestrated Proximal Extension Stent must have the ability to overlap the bifurcated stent graft by at least 3cm.
  • Aortic diameter at the most caudal renal artery of 18 to 36mm

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 or myocardial infarction;
  • Prior renal transplant;
  • Length of either renal artery to be stented <13mm;
  • Significant occlusive disease of either renal artery (>70% stenosis);
  • An essential accessory renal artery;
  • Indispensable inferior mesenteric artery;
  • 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)
  • Existing renal stent;
  • Pre-planned need for concomitant procedure (e.g. surgical conduit for vascular access, hypogastric artery embolization/coil, renal artery angioplasty)
  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: NCT01491945

  Show 24 Study Locations
Sponsors and Collaborators
Endologix
Investigators
Principal Investigator: Daniel G Clair, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Endologix
ClinicalTrials.gov Identifier: NCT01491945     History of Changes
Other Study ID Numbers: CP-0004
Study First Received: October 20, 2011
Last Updated: June 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Endologix:
Abdominal aortic aneurysm
Renal stent
Juxtarenal
Pararenal
Endovascular

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

ClinicalTrials.gov processed this record on September 14, 2014