Feasibility and Safety 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:
NCT01348828
First received: May 3, 2011
Last updated: June 4, 2013
Last verified: June 2013

May 3, 2011
June 4, 2013
November 2011
May 2012   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT01348828 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System
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

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.

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
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Abdominal Aortic Aneurysm
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
Not Provided
Mertens R, Bergoeing M, Mariné L, Valdés F, Krämer A, Vergara J. Ventana fenestrated stent-graft system for endovascular repair of juxtarenal aortic aneurysms. J Endovasc Ther. 2012 Apr;19(2):173-8. doi: 10.1583/11-3706.1. PubMed PMID: 22545881.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
May 2017
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Chile,   France,   Netherlands,   New Zealand,   United Kingdom
 
NCT01348828
CP-0003
Yes
Endologix
Endologix
Not Provided
Principal Investigator: Daniel Clair, MD The Cleveland Clinic
Principal Investigator: Andrew Holden, MD Auckland City Hospital
Principal Investigator: Renato Mertens, MD Hospital Universidad Catolica
Endologix
June 2013

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