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The Vascutek AnacondaTM Stent Graft System Phase II IDE Study

Primary Purpose

Infrarenal Abdominal Aortic Aneurysm

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Anaconda Stent Graft System
Anaconda ONE-LOK Stent Graft System
Sponsored by
Terumo CVS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infrarenal Abdominal Aortic Aneurysm

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female ≥18 and ≤ 85 years of age. Females must be non-pregnant, non-lactating, and not planning to become pregnant during the study period
  • Females of childbearing potential must use acceptable methods of contraception, be at least one year post-menopausal or be surgically sterile
  • Willing and able to comply with the 5 year follow-up period
  • Willing to give informed written consent prior to enrollment
  • Males with infrarenal AAA ≥ 4.5cm in diameter, or AAA growth ≥ 1.0cm/yr; females with infrarenal AAA ≥ 4.0cm in diameter, or AAA growth ≥ 1.0cm/yr
  • Infrarenal AAA with a proximal neck diameter of 16.0 - 31.0mm (Anaconda Stent Graft System)
  • Infrarenal AAA with a proximal neck diameter of 17.5 - 31.0mm (Anaconda ONE-LOK Stent Graft System)
  • Infrarenal AAA with at least 15mm length of non-aneurysm proximal neck
  • Infrarenal AAA with an angle of ≤ 60 degrees relative to the long axis of the aneurysm
  • Iliac artery distal fixation sites ≥ 20mm in length
  • Iliac artery distal fixation site ≤ 21mm in diameter
  • Ability to preserve at least one hypogastric artery
  • Femoral/iliac artery access vessels, size and morphology should be compatible with the appropriate introducer sheath (18 F, 20 F or 23 F).

Exclusion Criteria;

  • Pregnant and lactating females or females of childbearing potential unless using acceptable method contraception
  • Known sensitivity or allergy to nitinol or polyester
  • Known allergy or intolerance of radiopaque contrast agents which cannot be pre-treated
  • Thrombus, calcification, and/or plaque ≥ 2mm in thickness and/or ≥ 50% (180 degrees) continuous coverage of the vessel circumference in the intended fixation site
  • Irregularly shaped calcification and/or plaque that may compromise the sealing and fixation at the proximal or distal fixation sites
  • Ruptured or leaking AAA
  • Mycotic or inflammatory AAA
  • Genetic connective tissue disorder (i.e. Marfans or Ehlers-Danlos syndromes)
  • Previous AAA repair
  • Requires emergent AAA repair
  • Concomitant thoracoabdominal aortic aneurysm
  • Active systemic infection
  • Myocardial infarction ≤10 weeks prior to procedure
  • Aneurysm extends above renal arteries
  • Dialysis dependent renal failure or creatinine > 2.5mg/dL
  • Significant (>80%) renal artery stenosis not readily treatable
  • End-stage chronic obstructive pulmonary disorder
  • Patient is clinically and morbidly obese such that the required imaging would be prevented
  • Patient has an uncorrectable bleeding abnormality
  • Subject has other medical, social, or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre- and post- treatment

Sites / Locations

  • Arizona Heart Institute
  • Central Arkansas Veteran's Hospital
  • Long Beach VA Healthcare System
  • University of Southern California Healthcare Consultation Ctr. II
  • West Los Angeles VA Medical Centre
  • Kaiser Permanente Hospital
  • University of Florida
  • Florida Vascular Consultants
  • Miller School of Medicine University of Miami
  • Southern Illinois Univ. School of Med.
  • Indiana University Vascular Surgery, Methodist Hospital
  • Massachusetts General Hospital Vascular and Endovascular Surgery
  • Michigan Vascular Research Center
  • University of Medicine and Dentistry of NJ
  • Center for Vascular Awareness
  • University of Buffalo surgeons, Inc.
  • Oregon Health and Science University
  • Vascular and Transplant Specialist
  • Peter Lougheed Center
  • St. Clare's Hospital
  • London Health Science Center
  • The Ottawa Hospital
  • Toronto General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anaconda

Arm Description

Outcomes

Primary Outcome Measures

Successful Aneurysm Treatment
defined as a composite endpoint of subjects who have successful delivery and deployment of the Anaconda™ Stent Graft at the initial procedure and at ≤365 days post-procedure and absence of: Aneurysm growth ≥ 5 mm as evaluated by the core laboratory Post-operative interventions to correct type I or III endoleaks Conversion to open surgical repair Failed patency of both limbs Migration requiring secondary procedure or intervention Significant fracture Aneurysm rupture
Freedom From Major Adverse Events
The reported values represent the patients that did not experience a Major Adverse Event. Participants did NOT experience: All-Cause Mortality Myocardial Infarction (MI) Cerebrovascular Accident (CVA) Renal Failure Respiratory Failure Paralysis or Paraplegia, or Bowel Ischemia

Secondary Outcome Measures

Secondary Effectiveness, Technical Success
Introduction and deployment of the Stent Graft in the absence of mortality, conversion to surgical repair, failed patency of both limbs, and evidence of a Type I or III endoleak through the first 24 hour post-operative period. The table below indicates the subjects who met the criteria for technical success based on Core Lab imaging evaluations.

Full Information

First Posted
January 22, 2008
Last Updated
October 12, 2017
Sponsor
Terumo CVS
Collaborators
Vascutek Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00612924
Brief Title
The Vascutek AnacondaTM Stent Graft System Phase II IDE Study
Official Title
The Anaconda Endovascular Graft US FDA Phase II Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Terumo CVS
Collaborators
Vascutek Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The Phase I safety study is now complete. FDA approval has been granted to proceed to Phase II. The primary objectives of the Phase II study is to assess the safety and effectiveness of the Anaconda Stent Graft System in subjects presenting with abdominal aortic aneurysm (AAA). The secondary objectives of this study are to assess additional clinical outcomes measurements associated with treatment of AAA using the Anaconda Stent Graft System
Detailed Description
Abdominal aortic aneurysms afflict a large number of patients in the United States and world-wide. The treatment of this disorder is based upon the concept of aneurysm repair prior to the presentation of symptoms or rupture. Thus aneurysm repair can be viewed as a prophylactic procedure embarked upon to prevent the disastrous complications of a ruptured aneurysm. The decision to treat an aneurysm electively is based upon a risk to benefit ratio. Treatment options include medical management of co-morbidities (hypertension, pulmonary disease, etc.) with observation of the aneurysm, open surgical aneurysm repair through a transabdominal or retroperitoneal approach, and endovascular aneurysm repair. The decision to intervene is based upon physician judgment. Once the decision to intervene is made, the mode of the intervention must be chosen. Although open surgical repair is more invasive and has been noted to have a higher morbidity and mortality(1;2) than most endovascular reports, few argue with the effectiveness of the procedure. To date, open surgical repair remains the gold standard of care for the aneurysm patient. Endovascular repair has several beneficial characteristics in comparison to an open surgical approach. They include the potential for decreased need for blood transfusions, shorter intensive care unit and total hospital stays, the lack of endotracheal intubation, to name a few. However, the procedure requires adequate imaging prior to graft placement and during the follow-up period, in addition to the availability of a trained team to ensure proper device placement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infrarenal Abdominal Aortic Aneurysm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
195 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anaconda
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Anaconda Stent Graft System
Intervention Description
Endovascular device
Intervention Type
Device
Intervention Name(s)
Anaconda ONE-LOK Stent Graft System
Intervention Description
Endovascular device
Primary Outcome Measure Information:
Title
Successful Aneurysm Treatment
Description
defined as a composite endpoint of subjects who have successful delivery and deployment of the Anaconda™ Stent Graft at the initial procedure and at ≤365 days post-procedure and absence of: Aneurysm growth ≥ 5 mm as evaluated by the core laboratory Post-operative interventions to correct type I or III endoleaks Conversion to open surgical repair Failed patency of both limbs Migration requiring secondary procedure or intervention Significant fracture Aneurysm rupture
Time Frame
365 days
Title
Freedom From Major Adverse Events
Description
The reported values represent the patients that did not experience a Major Adverse Event. Participants did NOT experience: All-Cause Mortality Myocardial Infarction (MI) Cerebrovascular Accident (CVA) Renal Failure Respiratory Failure Paralysis or Paraplegia, or Bowel Ischemia
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Secondary Effectiveness, Technical Success
Description
Introduction and deployment of the Stent Graft in the absence of mortality, conversion to surgical repair, failed patency of both limbs, and evidence of a Type I or III endoleak through the first 24 hour post-operative period. The table below indicates the subjects who met the criteria for technical success based on Core Lab imaging evaluations.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female ≥18 and ≤ 85 years of age. Females must be non-pregnant, non-lactating, and not planning to become pregnant during the study period Females of childbearing potential must use acceptable methods of contraception, be at least one year post-menopausal or be surgically sterile Willing and able to comply with the 5 year follow-up period Willing to give informed written consent prior to enrollment Males with infrarenal AAA ≥ 4.5cm in diameter, or AAA growth ≥ 1.0cm/yr; females with infrarenal AAA ≥ 4.0cm in diameter, or AAA growth ≥ 1.0cm/yr Infrarenal AAA with a proximal neck diameter of 16.0 - 31.0mm (Anaconda Stent Graft System) Infrarenal AAA with a proximal neck diameter of 17.5 - 31.0mm (Anaconda ONE-LOK Stent Graft System) Infrarenal AAA with at least 15mm length of non-aneurysm proximal neck Infrarenal AAA with an angle of ≤ 60 degrees relative to the long axis of the aneurysm Iliac artery distal fixation sites ≥ 20mm in length Iliac artery distal fixation site ≤ 21mm in diameter Ability to preserve at least one hypogastric artery Femoral/iliac artery access vessels, size and morphology should be compatible with the appropriate introducer sheath (18 F, 20 F or 23 F). Exclusion Criteria; Pregnant and lactating females or females of childbearing potential unless using acceptable method contraception Known sensitivity or allergy to nitinol or polyester Known allergy or intolerance of radiopaque contrast agents which cannot be pre-treated Thrombus, calcification, and/or plaque ≥ 2mm in thickness and/or ≥ 50% (180 degrees) continuous coverage of the vessel circumference in the intended fixation site Irregularly shaped calcification and/or plaque that may compromise the sealing and fixation at the proximal or distal fixation sites Ruptured or leaking AAA Mycotic or inflammatory AAA Genetic connective tissue disorder (i.e. Marfans or Ehlers-Danlos syndromes) Previous AAA repair Requires emergent AAA repair Concomitant thoracoabdominal aortic aneurysm Active systemic infection Myocardial infarction ≤10 weeks prior to procedure Aneurysm extends above renal arteries Dialysis dependent renal failure or creatinine > 2.5mg/dL Significant (>80%) renal artery stenosis not readily treatable End-stage chronic obstructive pulmonary disorder Patient is clinically and morbidly obese such that the required imaging would be prevented Patient has an uncorrectable bleeding abnormality Subject has other medical, social, or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre- and post- treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Pregulman, MD
Organizational Affiliation
Terumo Cardiovascular Systems Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Heart Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Central Arkansas Veteran's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Long Beach VA Healthcare System
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
University of Southern California Healthcare Consultation Ctr. II
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-4612
Country
United States
Facility Name
West Los Angeles VA Medical Centre
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Kaiser Permanente Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0128
Country
United States
Facility Name
Florida Vascular Consultants
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Miller School of Medicine University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Southern Illinois Univ. School of Med.
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794-9638
Country
United States
Facility Name
Indiana University Vascular Surgery, Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Massachusetts General Hospital Vascular and Endovascular Surgery
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Michigan Vascular Research Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48507
Country
United States
Facility Name
University of Medicine and Dentistry of NJ
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903-0019
Country
United States
Facility Name
Center for Vascular Awareness
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
University of Buffalo surgeons, Inc.
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Vascular and Transplant Specialist
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Peter Lougheed Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6J4
Country
Canada
Facility Name
St. Clare's Hospital
City
St Johns
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1C 5B8
Country
Canada
Facility Name
London Health Science Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
10894211
Citation
Johnston SC, Wilson CB, Halbach VV, Higashida RT, Dowd CF, McDermott MW, Applebury CB, Farley TL, Gress DR. Endovascular and surgical treatment of unruptured cerebral aneurysms: comparison of risks. Ann Neurol. 2000 Jul;48(1):11-9. doi: 10.1002/1531-8249(200007)48:13.3.co;2-m.
Results Reference
background
PubMed Identifier
11174829
Citation
Greenberg RK, Lawrence-Brown M, Bhandari G, Hartley D, Stelter W, Umscheid T, Chuter T, Ivancev K, Green R, Hopkinson B, Semmens J, Ouriel K. An update of the Zenith endovascular graft for abdominal aortic aneurysms: initial implantation and mid-term follow-up data. J Vasc Surg. 2001 Feb;33(2 Suppl):S157-64. doi: 10.1067/mva.2001.111683.
Results Reference
background
Links:
URL
http://www.vascutek.com/
Description
Company website

Learn more about this trial

The Vascutek AnacondaTM Stent Graft System Phase II IDE Study

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