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The VISIBILITY Iliac study is a prospective, multi-center, non-randomized study confirming the safety and effectiveness of stenting using the Visi-Proâ„¢ Balloon Expandable Stent System for the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visi-Proâ„¢ Balloon Expandable Stent System | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visi-Proâ„¢ Balloon Expandable Stent System | Device | Implantation of one or more study devices in the common and/or external iliac artery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Event Rate at 9 Months | 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. | 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter L. Faries, M.D. | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| John H. Rundback, M.D. | Holy Name Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holy Name Medical Center | Teaneck | New Jersey | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28351204 | Derived | Rundback JH, Peeters P, George JC, Jaff MR, Faries PL. Results From the VISIBILITY Iliac Study: Primary and Cohort Outcomes at 9 Months. J Endovasc Ther. 2017 Jun;24(3):342-348. doi: 10.1177/1526602817692960. Epub 2017 Feb 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Visi-Proâ„¢ 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-Proâ„¢ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Visi-Proâ„¢ 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-Proâ„¢ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Major Adverse Event Rate at 9 Months | 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. | Posted | Number | percentage of participants | 9 months |
|
All events that occured within 9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Visi-Proâ„¢ 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-Proâ„¢ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Cihlar | Medtronic | 763-398-7932 | stephanie.a.cihlar@medtronic.com |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 38 |
| 75 |
| 22 |
| 75 |
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (14.1) | Systematic Assessment |
|
| Faecal incontinence | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Catheter site haematoma | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hepatobiliary disorders | Hepatobiliary disorders | MedDRA (14.1) | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Renal artery stenosis | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Aortic occlusion | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Pleuropericarditis | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Stress cardiomyopathy | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Odynophagia | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Cyst | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (14.1) | Systematic Assessment |
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| Puncture site haemorrhage | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Systemic inflammatory response syndrome | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Thrombosis in device | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
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| Enterococcal sepsis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Wound infection | Immune system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| In-stent arterial restenosis | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Incision site haematoma | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Postoperative thoracic procedure complication | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Procedural hypertension | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Urinary retention postoperative | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Neuroendocrine carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
|
| Oesophageal adenocarcinoma stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Arterial spasm | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
| Femoral arterial stenosis | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
| Femoral artery occlusion | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
| Iliac artery occlusion | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
| Peripheral artery dissection | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
| Peripheral embolism | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
| Subclavian steal syndrome | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
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.
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |