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The Vascutek AnacondaTM Stent Graft System Phase II IDE Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00612924
Recruitment Status : Completed
First Posted : February 12, 2008
Results First Posted : March 9, 2016
Last Update Posted : October 16, 2017
Sponsor:
Collaborator:
Vascutek Ltd.
Information provided by (Responsible Party):
Terumo CVS

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Infrarenal Abdominal Aortic Aneurysm
Interventions Device: Anaconda Stent Graft System
Device: Anaconda ONE-LOK Stent Graft System
Enrollment 195
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Anaconda ONE-LOK
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 101 94
Completed 94 85
Not Completed 7 9
Arm/Group Title Anaconda ONE-LOK Total
Hide Arm/Group Description The original protocol identified that the Anaconda™ Stent Graft System would be used throughout the current Phase II study. However, a modified device design became available during the course of the current Phase II study and is called the ONELOK™ Stent Graft System. As the modifications to the device design are considered minor, there are no expected differences in the anticipated safety or effectiveness of the device. The design changes relate primary to a uni-docking zone in the bifurcate body to maximize sizing compatibilities between the bifurcate body and the iliac limbs. [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 101 94 195
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 94 participants 195 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
  14.9%
15
  16.0%
30
  15.4%
>=65 years
86
  85.1%
79
  84.0%
165
  84.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants 94 participants 195 participants
71  (7.1) 71  (7.3) 71  (7.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 94 participants 195 participants
Female
16
  15.8%
12
  12.8%
28
  14.4%
Male
85
  84.2%
82
  87.2%
167
  85.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants 94 participants 195 participants
Canada 40 34 74
United States 61 60 121
1.Primary Outcome
Title Successful Aneurysm Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
In the ONE-LOK™ population, 85 subjects had efficacy endpoints and 9 subjects are missing due to withdrawal prior to 365-day follow-up. For the Anaconda population, 95 subjects had efficacy endpoints and 6 are missing data due to withdrawal prior to the 365-day follow-up.
Arm/Group Title Anaconda ONE LOK
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 95 85
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
90.9
(84.4 to 95.4)
93.7
(88.5 to 97.9)
2.Primary Outcome
Title Freedom From Major Adverse Events
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
One Anaconda patient is not included in the analysis because their 30 day data was not reported.
Arm/Group Title Anaconda ONE LOK
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 100 94
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
96.6
(93.2 to 98.9)
96.2
(92.3 to 98.6)
3.Secondary Outcome
Title Secondary Effectiveness, Technical Success
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
151 subjects (81 Anaconda and 70 ONE-LOK) had imaging available for core lab review and determination of technical success.
Arm/Group Title Anaconda ONE LOK Total
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Total of all reporting groups
Overall Number of Participants Analyzed 81 70 151
Measure Type: Number
Unit of Measure: participants
77 69 146
Time Frame 365 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Anaconda ONE-LOK
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Anaconda ONE-LOK
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Anaconda ONE-LOK
Affected / at Risk (%) Affected / at Risk (%)
Total   16/101 (15.84%)   8/94 (8.51%) 
Blood and lymphatic system disorders     
Anaemia  1/101 (0.99%)  0/94 (0.00%) 
Leukocytosis  1/101 (0.99%)  0/94 (0.00%) 
Cardiac disorders     
Angina pectoris  1/101 (0.99%)  0/94 (0.00%) 
Atrial fibrillation  0/101 (0.00%)  1/94 (1.06%) 
Cardiac failure congestive  0/101 (0.00%)  2/94 (2.13%) 
Cardio-respiratory arrest  1/101 (0.99%)  0/94 (0.00%) 
Coronary artery disease  1/101 (0.99%)  0/94 (0.00%) 
Coronary artery stenosis  1/101 (0.99%)  0/94 (0.00%) 
Left ventricular dysfunction  0/101 (0.00%)  1/94 (1.06%) 
Myocardial Infarction  2/101 (1.98%)  1/94 (1.06%) 
Nodal arrhythmia  1/101 (0.99%)  0/94 (0.00%) 
Sinus tachycardia  0/101 (0.00%)  1/94 (1.06%) 
Ventricular Tachycardia  0/101 (0.00%)  1/94 (1.06%) 
Ear and labyrinth disorders     
Vertigo  1/101 (0.99%)  1/94 (1.06%) 
Gastrointestinal disorders     
Abdominal Pain  1/101 (0.99%)  2/94 (2.13%) 
Colitis ischaemic  1/101 (0.99%)  0/94 (0.00%) 
Constipation  1/101 (0.99%)  0/94 (0.00%) 
Diarrhoea  1/101 (0.99%)  0/94 (0.00%) 
Gastrointestinal haemorrhage  0/101 (0.00%)  1/94 (1.06%) 
Ileus  2/101 (1.98%)  2/94 (2.13%) 
Retroperitoneal haemorrhage  1/101 (0.99%)  0/94 (0.00%) 
Upper gastrointestinal haemorrhage  0/101 (0.00%)  1/94 (1.06%) 
Vomiting  1/101 (0.99%)  0/94 (0.00%) 
General disorders     
Death  0/101 (0.00%)  1/94 (1.06%) 
Pyrexia  1/101 (0.99%)  3/94 (3.19%) 
Infections and infestations     
Candiduria  0/101 (0.00%)  1/94 (1.06%) 
Cellulitis  1/101 (0.99%)  1/94 (1.06%) 
Clostridium difficile colitis  1/101 (0.99%)  0/94 (0.00%) 
Oesophageal candidiasis  1/101 (0.99%)  0/94 (0.00%) 
Orchitis  1/101 (0.99%)  0/94 (0.00%) 
Pneumonia  1/101 (0.99%)  2/94 (2.13%) 
Septic shock  0/101 (0.00%)  1/94 (1.06%) 
Serratia bacteraemia  1/101 (0.99%)  0/94 (0.00%) 
Urinary tract infection  1/101 (0.99%)  1/94 (1.06%) 
Urinary tract infection bacterial  1/101 (0.99%)  0/94 (0.00%) 
Urinary tract infection enterococcal  0/101 (0.00%)  1/94 (1.06%) 
Injury, poisoning and procedural complications     
Coronary artery restenosis  1/101 (0.99%)  0/94 (0.00%) 
Device material issue  1/101 (0.99%)  0/94 (0.00%) 
Device Occlusion  1/101 (0.99%)  0/94 (0.00%) 
Incision site pain  0/101 (0.00%)  1/94 (1.06%) 
Incisional hernia  0/101 (0.00%)  1/94 (1.06%) 
Post procedural myocardial infarction  2/101 (1.98%)  0/94 (0.00%) 
Postoperative fever  1/101 (0.99%)  1/94 (1.06%) 
Postoperative Ileus  1/101 (0.99%)  0/94 (0.00%) 
Postoperative renal failure  1/101 (0.99%)  0/94 (0.00%) 
Renal failure  1/101 (0.99%)  0/94 (0.00%) 
Seroma  1/101 (0.99%)  0/94 (0.00%) 
Stent-graft endoleak  3/101 (2.97%)  2/94 (2.13%) 
Subdural haematoma  1/101 (0.99%)  0/94 (0.00%) 
Thrombosis in device  4/101 (3.96%)  2/94 (2.13%) 
Vascular graft occlusion  5/101 (4.95%)  3/94 (3.19%) 
Vascular injury  1/101 (0.99%)  0/94 (0.00%) 
Vascular pseudoaneurysm  1/101 (0.99%)  0/94 (0.00%) 
Wound  1/101 (0.99%)  0/94 (0.00%) 
Investigations     
Hepatic enzyme increased  1/101 (0.99%)  0/94 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1/101 (0.99%)  0/94 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back Pain  0/101 (0.00%)  1/94 (1.06%) 
Muscular weakness  1/101 (0.99%)  0/94 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myeloid leukaemia  0/101 (0.00%)  1/94 (1.06%) 
Bladder cancer  0/101 (0.00%)  1/94 (1.06%) 
Lung neoplasm  1/101 (0.99%)  0/94 (0.00%) 
Lung neoplasm malignant  1/101 (0.99%)  0/94 (0.00%) 
Pancreatic carcinoma  0/101 (0.00%)  1/94 (1.06%) 
Renal cell carcinoma  0/101 (0.00%)  1/94 (1.06%) 
Nervous system disorders     
Altered state of consciousness  0/101 (0.00%)  1/94 (1.06%) 
Dizziness  0/101 (0.00%)  1/94 (1.06%) 
Haemorrhage Intracranial  0/101 (0.00%)  1/94 (1.06%) 
Presyncope  0/101 (0.00%)  1/94 (1.06%) 
Syncope  1/101 (0.99%)  0/94 (0.00%) 
Transient ischemic attack  1/101 (0.99%)  0/94 (0.00%) 
Psychiatric disorders     
Confusional State  0/101 (0.00%)  2/94 (2.13%) 
Delirium  1/101 (0.99%)  1/94 (1.06%) 
Delirium tremens  0/101 (0.00%)  1/94 (1.06%) 
Depression  1/101 (0.99%)  0/94 (0.00%) 
Renal and urinary disorders     
Haematuria  1/101 (0.99%)  0/94 (0.00%) 
Renal artery occlusion  1/101 (0.99%)  0/94 (0.00%) 
Renal failure  1/101 (0.99%)  0/94 (0.00%) 
Renal failure chronic  0/101 (0.00%)  2/94 (2.13%) 
Tubulointerstitial nephritis  1/101 (0.99%)  0/94 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  0/101 (0.00%)  1/94 (1.06%) 
Bronchopleural fistula  1/101 (0.99%)  0/94 (0.00%) 
Chronic obstructive pulmonary disease  1/101 (0.99%)  2/94 (2.13%) 
Pleural effusion  0/101 (0.00%)  1/94 (1.06%) 
Pleuritic pain  0/101 (0.00%)  1/94 (1.06%) 
Pneumonia aspiration  1/101 (0.99%)  1/94 (1.06%) 
Pneumothorax  1/101 (0.99%)  0/94 (0.00%) 
Pulmonary oedema  0/101 (0.00%)  2/94 (2.13%) 
Respiratory Failure  0/101 (0.00%)  2/94 (2.13%) 
Skin and subcutaneous tissue disorders     
Rash  0/101 (0.00%)  1/94 (1.06%) 
Surgical and medical procedures     
Stent malfunction  0/101 (0.00%)  1/94 (1.06%) 
Stent removal  1/101 (0.99%)  0/94 (0.00%) 
Vascular disorders     
Aortic Aneurysm  0/101 (0.00%)  1/94 (1.06%) 
Femoral Artery Aneurysm  1/101 (0.99%)  0/94 (0.00%) 
Femoral artery occlusion  0/101 (0.00%)  2/94 (2.13%) 
Hypertension  0/101 (0.00%)  1/94 (1.06%) 
Hypotension  2/101 (1.98%)  0/94 (0.00%) 
Intermittent claudication  0/101 (0.00%)  1/94 (1.06%) 
Peripheral arterial occlusive disease  0/101 (0.00%)  3/94 (3.19%) 
Peripheral Artery Aneurysm  1/101 (0.99%)  0/94 (0.00%) 
Peripheral artery stenosis  0/101 (0.00%)  1/94 (1.06%) 
Peripheral artery thrombosis  1/101 (0.99%)  2/94 (2.13%) 
Peripheral embolism  1/101 (0.99%)  1/94 (1.06%) 
Peripheral ischaemia  0/101 (0.00%)  1/94 (1.06%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Anaconda ONE-LOK
Affected / at Risk (%) Affected / at Risk (%)
Total   16/101 (15.84%)   20/94 (21.28%) 
Blood and lymphatic system disorders     
Leukocytosis  5/101 (4.95%)  3/94 (3.19%) 
Gastrointestinal disorders     
Constipation  8/101 (7.92%)  4/94 (4.26%) 
Nausea  8/101 (7.92%)  4/94 (4.26%) 
General disorders     
Pyrexia  5/101 (4.95%)  6/94 (6.38%) 
Infections and infestations     
Urinary Tract Infection  3/101 (2.97%)  9/94 (9.57%) 
Injury, poisoning and procedural complications     
Stent-graft Endoleak  6/101 (5.94%)  10/94 (10.64%) 
Procedural Pain  8/101 (7.92%)  7/94 (7.45%) 
Metabolism and nutrition disorders     
Hypokalemia  6/101 (5.94%)  3/94 (3.19%) 
Musculoskeletal and connective tissue disorders     
Pain in Extremity  2/101 (1.98%)  6/94 (6.38%) 
Back Pain  4/101 (3.96%)  5/94 (5.32%) 
Vascular disorders     
Hypertension  10/101 (9.90%)  10/94 (10.64%) 
Hypotension  7/101 (6.93%)  3/94 (3.19%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Amanda Isula, Clinical Research Coordinator
Organization: Terumo
Phone: 800-262-3304 ext 5549
EMail: amanda.isula@terumomedical.com
Layout table for additonal information
Responsible Party: Terumo CVS
ClinicalTrials.gov Identifier: NCT00612924    
Other Study ID Numbers: ANA-006
G030036 ( Other Identifier: FDA G030036 )
First Submitted: January 22, 2008
First Posted: February 12, 2008
Results First Submitted: February 10, 2016
Results First Posted: March 9, 2016
Last Update Posted: October 16, 2017