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Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Endologix
ClinicalTrials.gov Identifier:
NCT01348828
First received: May 3, 2011
Last updated: October 3, 2012
Last verified: October 2012
History of Changes
  Purpose

The aim of this study is to evaluate the safety and feasibility of the Endologix Fenestrated Stent Graft System for the endovascular repair of juxtarenal or pararenal aortic aneurysms.


Condition Intervention Phase
Abdominal Aortic Aneurysm
 Device: Endovascular Aortic Aneurysm Repair (Endologix 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 Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System for the Endovascular Repair of Juxtarenal/Pararenal (JAA/PAA) Aneurysms

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Endologix:

Primary Outcome Measures:
  • Primary Safety Endpoint [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

    Major adverse events defined as:

    • All-cause death
    • Bowel ischemia
    • Myocardial infarction
    • Paraplegia
    • Renal failure
    • Respiratory failure
    • Stroke
    • Blood loss >=1,000cc


Secondary Outcome Measures:
  • Feasibility/effectiveness [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    Successful device delivery and deployment with patency of the renal and aortic endografts without Type I/III endoleak.

  • Procedural/in-hospital evaluations [ Time Frame: Procedurally and to hospital discharge ] [ Designated as safety issue: Yes ]
    Anesthesia time; fluoroscopy time; contrast volume; estimated blood loss; % requiring transfusion; procedure time; ICU time; time to hospital discharge

  • Mortality [ Time Frame: Procedurally and to 5 Years ] [ Designated as safety issue: Yes ]
    All-cause and aneurysm-related

  • Major Adverse Events [ Time Frame: >30 Days to 5 Years ] [ Designated as safety issue: Yes ]
    All-cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, blood loss >1,000cc

  • Adverse Events [ Time Frame: Procedurally and to 5 Years ] [ Designated as safety issue: Yes ]
    All serious and non-serious adverse events

  • Renal Dysfunction [ Time Frame: 30 Days, 6 Months and Years 1 to 5 ] [ Designated as safety issue: Yes ]
    Reduction in estimated glomerular filtration rate (eGFR) >30% from the preoperative value

  • Aneurysm Rupture [ Time Frame: Procedurally and to 5 Years ] [ Designated as safety issue: Yes ]
    Internal bleeding or leaking of blood from the aneurysm subsequent to the index procedure

  • Conversion to Open Repair [ Time Frame: Procedurally and to 5 Years ] [ Designated as safety issue: Yes ]
    Open surgical repair of the aortic aneurysm due to unsuccessful delivery or deployment of the stent graft, due to complications or other clinical situations that precluded successful endovascular treatment, or at any time following initial successful endovascular treatment for any reason

  • Distal Blood Flow [ Time Frame: Pre-discharge, 30 Days, 6 Months, and Years 1 to 5 ] [ Designated as safety issue: Yes ]
    Ankle-brachial index measurements and changes over time

  • Renal Stent Graft Patency and Integrity [ Time Frame: 30 Days, 6 Months, and Years 1 to 5 ] [ Designated as safety issue: Yes ]
    Patent luminal flow; absence of kinking, stenosis, occlusion, stent fracture, graft failure, or renal infarct >30%

  • Stent Graft Patency and Integrity [ Time Frame: 30 Days, 6 Months, and Years 1 to 5 ] [ Designated as safety issue: Yes ]
    Bifurcated and fenestrated stent graft patent luminal flow; absence of stent fracture or graft fatigue/failure

  • Endograft Performance [ Time Frame: 30 Days, 6 Months, and Years 1 to 5 ] [ Designated as safety issue: No ]
    Change in aneurysm sac diameter from the first post-procedural measurement; incidence of endoleak; incidence of device migration; incidence of limb occlusion

  • Secondary Procedures [ Time Frame: 30 Days, 6 Months, and Years 1 to 5 ] [ Designated as safety issue: No ]
    Non-diagnostic intervention after the index procedure intended to correct or repair an endoleak (device-related: Type I (proximal or distal), Type III, Type IV; non-device related: Type II), device migration, or other device defect.


Estimated Enrollment: 30
Study Start Date: November 2011
Estimated Study Completion Date: May 2017
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System)
    Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System
    Other Names:
    • Ventana
    • Xpand
Detailed Description:

The Endologix Fenestrated Stent Graft System that will be used in this study has three components, listed below:

  1. Endologix unibody bifurcated stent graft
  2. Endologix fenestrated proximal extension stent graft
  3. Endologix renal stent graft
  Eligibility

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

Inclusion Criteria:

  • 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 >= 70
  • SMA to aortoiliac bifurcation length >=90mm
  • Proximal non-aneurysmal aortic neck below the SMA with diameter 18 to 34 mm, length >=15mm and angle <=60° to the aneurysm sac
  • Angle <=60° (clock face) between the SMA and CA
  • Renal arteries both at or below the SMA by <=35mm and within 30mm of each other axially, with 4 to 8mm lumen diameter, and with clockface angle of 90° to 210° to each other
  • Common iliac artery distal fixation site with: distal fixation length >=15mm, with diameter >=10 mm and <=23 mm and angle <=90° to the aortic bifurcation
  • Ability to preserve at least one hypogastric artery

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
  • Recent(within prior three months)myocardial infarction
  • Prior renal transplant
  • Length of either renal artery to be stented <12mm
  • Significant occlusive disease or calcification of either renal artery (>70%)
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01348828

Locations
United States, California
UCLA
Los Angeles, California, United States
United States, Indiana
University of Indiana
Indianapolis, Indiana, United States
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Chile
Hospital Universidad Catolica
Santiago, Chile
New Zealand
Auckland City Hospital
Auckland, New Zealand, 1032
Sponsors and Collaborators
Endologix
Investigators
Principal Investigator: Daniel Clair, MD The Cleveland Clinic
Principal Investigator: Andrew Holden, MD Auckland City Hospital
Principal Investigator: Renato Mertens, MD Hospital Universidad Catolica
  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: NCT01348828     History of Changes
Other Study ID Numbers: CP-0003
Study First Received: May 3, 2011
Last Updated: October 3, 2012
Health Authority: United States: Food and Drug Administration
Chile: Instituto de Salud Publica de Chile
France: Ministry of Health
New Zealand: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Endologix:
Abdominal Aortic Aneurysm
Fenestrated
Renal Stent
Juxtarenal
 Pararenal
Endologix
Renal

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

ClinicalTrials.gov processed this record on May 21, 2013