Trial Outcomes & Findings for The Vascutek AnacondaTM Stent Graft System Phase II IDE Study (NCT NCT00612924)
NCT ID: NCT00612924
Last Updated: 2017-10-16
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
195 participants
Primary outcome timeframe
365 days
Results posted on
2017-10-16
Participant Flow
Participant milestones
| Measure |
Anaconda
|
ONE-LOK
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
94
|
|
Overall Study
COMPLETED
|
94
|
85
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Vascutek AnacondaTM Stent Graft System Phase II IDE Study
Baseline characteristics by cohort
| Measure |
Anaconda
n=101 Participants
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.
|
ONE-LOK
n=94 Participants
|
Total
n=195 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
86 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
|
Age, Continuous
|
71 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
71 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
71 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
40 participants
n=5 Participants
|
34 participants
n=7 Participants
|
74 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=5 Participants
|
60 participants
n=7 Participants
|
121 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 365 daysPopulation: 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.
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
Outcome measures
| Measure |
Anaconda
n=95 Participants
|
ONE LOK
n=85 Participants
|
Total
|
|---|---|---|---|
|
Successful Aneurysm Treatment
|
90.9 percentage of patients
Interval 84.4 to 95.4
|
93.7 percentage of patients
Interval 88.5 to 97.9
|
—
|
PRIMARY outcome
Timeframe: 30 daysPopulation: One Anaconda patient is not included in the analysis because their 30 day data was not reported.
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
Outcome measures
| Measure |
Anaconda
n=100 Participants
|
ONE LOK
n=94 Participants
|
Total
|
|---|---|---|---|
|
Freedom From Major Adverse Events
|
96.6 percentage of patients
Interval 93.2 to 98.9
|
96.2 percentage of patients
Interval 92.3 to 98.6
|
—
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: 151 subjects (81 Anaconda and 70 ONE-LOK) had imaging available for core lab review and determination of 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.
Outcome measures
| Measure |
Anaconda
n=81 Participants
|
ONE LOK
n=70 Participants
|
Total
n=151 Participants
|
|---|---|---|---|
|
Secondary Effectiveness, Technical Success
|
77 participants
|
69 participants
|
146 participants
|
Adverse Events
Anaconda
Serious events: 16 serious events
Other events: 16 other events
Deaths: 0 deaths
ONE-LOK
Serious events: 8 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anaconda
n=101 participants at risk
|
ONE-LOK
n=94 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.99%
1/101 • 365 days
|
2.1%
2/94 • 365 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Blood and lymphatic system disorders
Anaemia
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Cardiac disorders
Angina pectoris
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Vascular disorders
Aortic Aneurysm
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Infections and infestations
Candiduria
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/101 • 365 days
|
2.1%
2/94 • 365 days
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Infections and infestations
Cellulitis
|
0.99%
1/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.99%
1/101 • 365 days
|
2.1%
2/94 • 365 days
|
|
Infections and infestations
Clostridium difficile colitis
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/101 • 365 days
|
2.1%
2/94 • 365 days
|
|
Gastrointestinal disorders
Constipation
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Cardiac disorders
Coronary artery disease
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Cardiac disorders
Coronary artery stenosis
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
General disorders
Death
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Psychiatric disorders
Delirium
|
0.99%
1/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Psychiatric disorders
Delirium tremens
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Psychiatric disorders
Depression
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Injury, poisoning and procedural complications
Device material issue
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Injury, poisoning and procedural complications
Device Occlusion
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Vascular disorders
Femoral Artery Aneurysm
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Vascular disorders
Femoral artery occlusion
|
0.00%
0/101 • 365 days
|
2.1%
2/94 • 365 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Renal and urinary disorders
Haematuria
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Nervous system disorders
Haemorrhage Intracranial
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Investigations
Hepatic enzyme increased
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Vascular disorders
Hypertension
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Vascular disorders
Hypotension
|
2.0%
2/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Gastrointestinal disorders
Ileus
|
2.0%
2/101 • 365 days
|
2.1%
2/94 • 365 days
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Cardiac disorders
Myocardial Infarction
|
2.0%
2/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Cardiac disorders
Nodal arrhythmia
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Infections and infestations
Oesophageal candidiasis
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Infections and infestations
Orchitis
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/101 • 365 days
|
3.2%
3/94 • 365 days
|
|
Vascular disorders
Peripheral Artery Aneurysm
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.99%
1/101 • 365 days
|
2.1%
2/94 • 365 days
|
|
Vascular disorders
Peripheral embolism
|
0.99%
1/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Infections and infestations
Pneumonia
|
0.99%
1/101 • 365 days
|
2.1%
2/94 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.99%
1/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
2.0%
2/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.99%
1/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Injury, poisoning and procedural complications
Postoperative Ileus
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Injury, poisoning and procedural complications
Postoperative renal failure
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Nervous system disorders
Presyncope
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/101 • 365 days
|
2.1%
2/94 • 365 days
|
|
General disorders
Pyrexia
|
0.99%
1/101 • 365 days
|
3.2%
3/94 • 365 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Renal and urinary disorders
Renal artery occlusion
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Injury, poisoning and procedural complications
Renal failure
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Renal and urinary disorders
Renal failure
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/101 • 365 days
|
2.1%
2/94 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/101 • 365 days
|
2.1%
2/94 • 365 days
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Infections and infestations
Septic shock
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Injury, poisoning and procedural complications
Seroma
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Infections and infestations
Serratia bacteraemia
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Surgical and medical procedures
Stent malfunction
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Surgical and medical procedures
Stent removal
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Injury, poisoning and procedural complications
Stent-graft endoleak
|
3.0%
3/101 • 365 days
|
2.1%
2/94 • 365 days
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Nervous system disorders
Syncope
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Injury, poisoning and procedural complications
Thrombosis in device
|
4.0%
4/101 • 365 days
|
2.1%
2/94 • 365 days
|
|
Nervous system disorders
Transient ischemic attack
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Infections and infestations
Urinary tract infection
|
0.99%
1/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
5.0%
5/101 • 365 days
|
3.2%
3/94 • 365 days
|
|
Injury, poisoning and procedural complications
Vascular injury
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Ear and labyrinth disorders
Vertigo
|
0.99%
1/101 • 365 days
|
1.1%
1/94 • 365 days
|
|
Gastrointestinal disorders
Vomiting
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
|
Injury, poisoning and procedural complications
Wound
|
0.99%
1/101 • 365 days
|
0.00%
0/94 • 365 days
|
Other adverse events
| Measure |
Anaconda
n=101 participants at risk
|
ONE-LOK
n=94 participants at risk
|
|---|---|---|
|
Vascular disorders
Hypertension
|
9.9%
10/101 • 365 days
|
10.6%
10/94 • 365 days
|
|
Injury, poisoning and procedural complications
Stent-graft Endoleak
|
5.9%
6/101 • 365 days
|
10.6%
10/94 • 365 days
|
|
Infections and infestations
Urinary Tract Infection
|
3.0%
3/101 • 365 days
|
9.6%
9/94 • 365 days
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
7.9%
8/101 • 365 days
|
7.4%
7/94 • 365 days
|
|
General disorders
Pyrexia
|
5.0%
5/101 • 365 days
|
6.4%
6/94 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
2.0%
2/101 • 365 days
|
6.4%
6/94 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.0%
4/101 • 365 days
|
5.3%
5/94 • 365 days
|
|
Gastrointestinal disorders
Constipation
|
7.9%
8/101 • 365 days
|
4.3%
4/94 • 365 days
|
|
Gastrointestinal disorders
Nausea
|
7.9%
8/101 • 365 days
|
4.3%
4/94 • 365 days
|
|
Vascular disorders
Hypotension
|
6.9%
7/101 • 365 days
|
3.2%
3/94 • 365 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.9%
6/101 • 365 days
|
3.2%
3/94 • 365 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.0%
5/101 • 365 days
|
3.2%
3/94 • 365 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60