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VISIBILITY™ Iliac 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: NCT01402700
Recruitment Status : Completed
First Posted : July 26, 2011
Results First Posted : September 16, 2015
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Peripheral Arterial Disease
Claudication
Intervention Device: Visi-Pro™ Balloon Expandable Stent System
Enrollment 75
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Visi-Pro™ Balloon Expandable Stent System
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 75
Completed 68
Not Completed 7
Reason Not Completed
Death             3
Withdrawal by Subject             3
Missed Visit             1
Arm/Group Title Visi-Pro™ Balloon Expandable Stent System
Hide Arm/Group Description

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 Number of Baseline Participants 75
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants
64.2  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants
Female
29
  38.7%
Male
46
  61.3%
1.Primary Outcome
Title Major Adverse Event Rate at 9 Months
Hide Description 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.
Time Frame 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Visi-Pro™ Balloon Expandable Stent System
Hide Arm/Group Description:

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 Number of Participants Analyzed 75
Measure Type: Number
Unit of Measure: percentage of participants
4.0
Time Frame All events that occured within 9 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Visi-Pro™ Balloon Expandable Stent System
Hide Arm/Group Description

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.

All-Cause Mortality
Visi-Pro™ Balloon Expandable Stent System
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Visi-Pro™ Balloon Expandable Stent System
Affected / at Risk (%) # Events
Total   38/75 (50.67%)    
Blood and lymphatic system disorders   
Anaemia  1  1/75 (1.33%)  2
Cardiac disorders   
Acute coronary syndrome  1  1/75 (1.33%)  1
Acute myocardial infarction  1  1/75 (1.33%)  1
Angina pectoris  1  1/75 (1.33%)  1
Angina unstable  1  1/75 (1.33%)  1
Atrial fibrillation  1  2/75 (2.67%)  2
Atrial flutter  1  1/75 (1.33%)  1
Cardiac arrest  1  1/75 (1.33%)  1
Cardiac failure congestive  1  2/75 (2.67%)  2
Coronary artery disease  1  1/75 (1.33%)  1
Ischaemic cardiomyopathy  1  1/75 (1.33%)  1
Myocardial infarction  1  2/75 (2.67%)  2
Pleuropericarditis  1  1/75 (1.33%)  1
Stress cardiomyopathy  1  1/75 (1.33%)  1
Ear and labyrinth disorders   
Vertigo  1  1/75 (1.33%)  1
Gastrointestinal disorders   
Faecal incontinence  1  1/75 (1.33%)  1
Gastrooesophageal reflux disease  1  1/75 (1.33%)  1
Haematemesis  1  1/75 (1.33%)  1
Hiatus hernia  1  1/75 (1.33%)  1
Inguinal hernia  1  1/75 (1.33%)  1
Odynophagia  1  1/75 (1.33%)  1
General disorders   
Catheter site haematoma  1  5/75 (6.67%)  5
Adverse drug reaction  1  1/75 (1.33%)  1
Chest pain  1  1/75 (1.33%)  1
Cyst  1  1/75 (1.33%)  1
Non-cardiac chest pain  1  1/75 (1.33%)  1
Puncture site haemorrhage  1  1/75 (1.33%)  1
Systemic inflammatory response syndrome  1  1/75 (1.33%)  1
Thrombosis in device  1  4/75 (5.33%)  6
Hepatobiliary disorders   
Hepatobiliary disorders  1  1/75 (1.33%)  1
Immune system disorders   
Wound infection  1  1/75 (1.33%)  1
Infections and infestations   
Abdominal abscess  1  1/75 (1.33%)  1
Cellulitis  1  1/75 (1.33%)  1
Enterococcal sepsis  1  1/75 (1.33%)  1
Gastroenteritis  1  1/75 (1.33%)  1
Lobar pneumonia  1  1/75 (1.33%)  1
Pneumonia  1  3/75 (4.00%)  3
Upper respiratory tract infection  1  1/75 (1.33%)  1
Injury, poisoning and procedural complications   
Forearm fracture  1  1/75 (1.33%)  1
Hip fracture  1  1/75 (1.33%)  1
In-stent arterial restenosis  1  1/75 (1.33%)  2
Incision site haematoma  1  1/75 (1.33%)  1
Post procedural haematoma  1  1/75 (1.33%)  1
Postoperative thoracic procedure complication  1  1/75 (1.33%)  2
Procedural hypertension  1  1/75 (1.33%)  1
Procedural nausea  1  1/75 (1.33%)  1
Urinary retention postoperative  1  1/75 (1.33%)  1
Vascular graft occlusion  1  1/75 (1.33%)  1
Metabolism and nutrition disorders   
Hyperglycaemia  1  1/75 (1.33%)  1
Musculoskeletal and connective tissue disorders   
Intervertebral disc degeneration  1  1/75 (1.33%)  1
Spinal column stenosis  1  2/75 (2.67%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lung cancer metastatic  1  2/75 (2.67%)  2
Neuroendocrine carcinoma metastatic  1  1/75 (1.33%)  1
Oesophageal adenocarcinoma stage III  1  1/75 (1.33%)  1
Nervous system disorders   
Ataxia  1  1/75 (1.33%)  1
Carotid artery stenosis  1  1/75 (1.33%)  1
Transient ischaemic attack  1  1/75 (1.33%)  1
Renal and urinary disorders   
Renal artery stenosis  1  3/75 (4.00%)  3
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure  1  1/75 (1.33%)  1
Chronic obstructive pulmonary disease  1  3/75 (4.00%)  3
Haemothorax  1  1/75 (1.33%)  1
Pleural effusion  1  1/75 (1.33%)  1
Pneumothorax  1  1/75 (1.33%)  1
Vascular disorders   
Aortic occlusion  1  1/75 (1.33%)  1
Arterial spasm  1  1/75 (1.33%)  1
Femoral arterial stenosis  1  1/75 (1.33%)  1
Femoral artery occlusion  1  3/75 (4.00%)  3
Hypertensive crisis  1  1/75 (1.33%)  1
Iliac artery occlusion  1  1/75 (1.33%)  1
Peripheral arterial occlusive disease  1  1/75 (1.33%)  1
Peripheral artery dissection  1  5/75 (6.67%)  5
Peripheral embolism  1  1/75 (1.33%)  1
Subclavian steal syndrome  1  1/75 (1.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.0%
Visi-Pro™ Balloon Expandable Stent System
Affected / at Risk (%) # Events
Total   22/75 (29.33%)    
Blood and lymphatic system disorders   
Anaemia  1  4/75 (5.33%)  4
Gastrointestinal disorders   
Diarrhoea  1  4/75 (5.33%)  4
Nausea  1  4/75 (5.33%)  4
General disorders   
Oedema peripheral  1  4/75 (5.33%)  5
Musculoskeletal and connective tissue disorders   
Back pain  1  6/75 (8.00%)  6
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
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.

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.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Stephanie Cihlar
Organization: Medtronic
Phone: 763-398-7932
EMail: stephanie.a.cihlar@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01402700     History of Changes
Other Study ID Numbers: CP-1000
First Submitted: July 25, 2011
First Posted: July 26, 2011
Results First Submitted: August 11, 2015
Results First Posted: September 16, 2015
Last Update Posted: March 7, 2018