Trial Outcomes & Findings for VISIBILITY™ Iliac Study (NCT NCT01402700)
NCT ID: NCT01402700
Last Updated: 2018-03-07
Results Overview
The Major Adverse Event rate at 9 months is defined as a composite of periprocedural death, in-hospital MI, clinically-driven target lesion revascularization and amputation of the treated limb through 9 months postprocedure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
9 months
Results posted on
2018-03-07
Participant Flow
Participant milestones
| Measure |
Visi-Pro™ Balloon Expandable Stent System
The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Visi-Pro™ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery.
|
|---|---|
|
Overall Study
STARTED
|
75
|
|
Overall Study
COMPLETED
|
68
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Visi-Pro™ Balloon Expandable Stent System
The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Visi-Pro™ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery.
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Missed Visit
|
1
|
Baseline Characteristics
VISIBILITY™ Iliac Study
Baseline characteristics by cohort
| Measure |
Visi-Pro™ Balloon Expandable Stent System
n=75 Participants
The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Visi-Pro™ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery.
|
|---|---|
|
Age, Continuous
|
64.2 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 monthsThe Major Adverse Event rate at 9 months is defined as a composite of periprocedural death, in-hospital MI, clinically-driven target lesion revascularization and amputation of the treated limb through 9 months postprocedure.
Outcome measures
| Measure |
Visi-Pro™ Balloon Expandable Stent System
n=75 Participants
The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Visi-Pro™ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery.
|
|---|---|
|
Major Adverse Event Rate at 9 Months
|
4.0 percentage of participants
|
Adverse Events
Visi-Pro™ Balloon Expandable Stent System
Serious events: 38 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Visi-Pro™ Balloon Expandable Stent System
n=75 participants at risk
The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Visi-Pro™ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery.
|
|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
1/75 • Number of events 2 • All events that occured within 9 months
|
|
Ear and labyrinth disorders
Vertigo
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Gastrointestinal disorders
Faecal incontinence
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
General disorders
Catheter site haematoma
|
6.7%
5/75 • Number of events 5 • All events that occured within 9 months
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Infections and infestations
Abdominal abscess
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
2.7%
2/75 • Number of events 2 • All events that occured within 9 months
|
|
Nervous system disorders
Ataxia
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Renal and urinary disorders
Renal artery stenosis
|
4.0%
3/75 • Number of events 3 • All events that occured within 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Vascular disorders
Aortic occlusion
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Cardiac disorders
Acute myocardial infarction
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Cardiac disorders
Angina pectoris
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Cardiac disorders
Angina unstable
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Cardiac disorders
Atrial fibrillation
|
2.7%
2/75 • Number of events 2 • All events that occured within 9 months
|
|
Cardiac disorders
Atrial flutter
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Cardiac disorders
Cardiac arrest
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Cardiac disorders
Cardiac failure congestive
|
2.7%
2/75 • Number of events 2 • All events that occured within 9 months
|
|
Cardiac disorders
Coronary artery disease
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Cardiac disorders
Myocardial infarction
|
2.7%
2/75 • Number of events 2 • All events that occured within 9 months
|
|
Cardiac disorders
Pleuropericarditis
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Cardiac disorders
Stress cardiomyopathy
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Gastrointestinal disorders
Haematemesis
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Gastrointestinal disorders
Hiatus hernia
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Gastrointestinal disorders
Odynophagia
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
General disorders
Adverse drug reaction
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
General disorders
Chest pain
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
General disorders
Cyst
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
General disorders
Non-cardiac chest pain
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
General disorders
Puncture site haemorrhage
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
General disorders
Systemic inflammatory response syndrome
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
General disorders
Thrombosis in device
|
5.3%
4/75 • Number of events 6 • All events that occured within 9 months
|
|
Infections and infestations
Cellulitis
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Infections and infestations
Enterococcal sepsis
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Infections and infestations
Gastroenteritis
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Infections and infestations
Lobar pneumonia
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Infections and infestations
Pneumonia
|
4.0%
3/75 • Number of events 3 • All events that occured within 9 months
|
|
Infections and infestations
Upper respiratory tract infection
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Immune system disorders
Wound infection
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Injury, poisoning and procedural complications
In-stent arterial restenosis
|
1.3%
1/75 • Number of events 2 • All events that occured within 9 months
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
1.3%
1/75 • Number of events 2 • All events that occured within 9 months
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
2.7%
2/75 • Number of events 2 • All events that occured within 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma metastatic
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma stage III
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Nervous system disorders
Carotid artery stenosis
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Nervous system disorders
Transient ischaemic attack
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
4.0%
3/75 • Number of events 3 • All events that occured within 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Vascular disorders
Arterial spasm
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Vascular disorders
Femoral arterial stenosis
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Vascular disorders
Femoral artery occlusion
|
4.0%
3/75 • Number of events 3 • All events that occured within 9 months
|
|
Vascular disorders
Hypertensive crisis
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Vascular disorders
Iliac artery occlusion
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Vascular disorders
Peripheral artery dissection
|
6.7%
5/75 • Number of events 5 • All events that occured within 9 months
|
|
Vascular disorders
Peripheral embolism
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Vascular disorders
Subclavian steal syndrome
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
Other adverse events
| Measure |
Visi-Pro™ Balloon Expandable Stent System
n=75 participants at risk
The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Visi-Pro™ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
4/75 • Number of events 4 • All events that occured within 9 months
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
4/75 • Number of events 4 • All events that occured within 9 months
|
|
General disorders
Oedema peripheral
|
5.3%
4/75 • Number of events 5 • All events that occured within 9 months
|
|
Gastrointestinal disorders
Nausea
|
5.3%
4/75 • Number of events 4 • All events that occured within 9 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
6/75 • Number of events 6 • All events that occured within 9 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There is an agreement between the Principal Investigator and Sponsor \[or its agents\] that restricts PI's rights to discuss or publish trial results without permission of the Sponsor. Trial is still ongoing.
- Publication restrictions are in place
Restriction type: OTHER