The Vascutek AnacondaTM Stent Graft System Phase II IDE Study

NCT00612924 | Completed Results DMC

• 2 other identifiers: ANA-006G030036
• Study Type: interventional
• Target: 195
• Locations: 2 countries
• Sites: 23

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

Conditions

Infrarenal Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (2)

• 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

  365 days

• 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

  30 days

Secondary Outcomes (1)

• Secondary Effectiveness, Technical Success

  24 hours

Study Arms (1)

Anaconda

EXPERIMENTAL

Device: Anaconda Stent Graft System; Device: Anaconda ONE-LOK Stent Graft System

Interventions

Anaconda Stent Graft System DEVICE

Endovascular device

Anaconda

Anaconda ONE-LOK Stent Graft System DEVICE

Endovascular device

Anaconda

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Terumo CVS: lead
• Vascutek Ltd.: collaborator

Study Sites (23)

Arizona Heart Institute

Phoenix, Arizona, 85006, United States

Location

Central Arkansas Veteran's Hospital

Little Rock, Arkansas, 72205, United States

Location

Long Beach VA Healthcare System

Long Beach, California, 90822, United States

Location

University of Southern California Healthcare Consultation Ctr. II

Los Angeles, California, 90033-4612, United States

Location

West Los Angeles VA Medical Centre

Los Angeles, California, 90073, United States

Location

Kaiser Permanente Hospital

San Francisco, California, 94115, United States

Location

University of Florida

Gainesville, Florida, 32610-0128, United States

Location

Florida Vascular Consultants

Maitland, Florida, 32751, United States

Location

Miller School of Medicine University of Miami

Miami, Florida, 33136, United States

Location

Southern Illinois Univ. School of Med.

Springfield, Illinois, 62794-9638, United States

Location

Indiana University Vascular Surgery, Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Massachusetts General Hospital Vascular and Endovascular Surgery

Boston, Massachusetts, 02114, United States

Location

Michigan Vascular Research Center

Flint, Michigan, 48507, United States

Location

University of Medicine and Dentistry of NJ

New Brunswick, New Jersey, 08903-0019, United States

Location

Center for Vascular Awareness

Albany, New York, 12205, United States

Location

University of Buffalo surgeons, Inc.

Buffalo, New York, 14203, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

Vascular and Transplant Specialist

Norfolk, Virginia, 23507, United States

Location

Peter Lougheed Center

Calgary, Alberta, T1Y 6J4, Canada

Location

St. Clare's Hospital

St. John's, Newfoundland and Labrador, A1C 5B8, Canada

Location

London Health Science Center

London, Ontario, N6A 5W9, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (2)

• 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.

  PMID: 10894211 BACKGROUND

• 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.

  PMID: 11174829 BACKGROUND

Related Links

• Company website

Results Point of Contact

• Title: Amanda Isula, Clinical Research Coordinator
• Organization: Terumo

amanda.isula@terumomedical.com

800-262-3304

Study Officials

• Steven Pregulman, MD

  Terumo Cardiovascular Systems Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2008
• First Posted: February 12, 2008
• Study Start: April 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: July 13, 2017
• Last Updated: October 16, 2017
• Results First Posted: March 9, 2016

Record last verified: 2017-10

Locations

CA (5); US (18)