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To determine the safety and effectiveness of Pipeline Embolization Device for the treatment of uncoilable or failed wide-necked intracranial aneurysms (IA).
Patients with large or giant aneurysms of the internal carotid artery treated with PED. Angiographic follow-up occurs at 3 and 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pipeline | Experimental | Placement of Pipeline Embolization Device in the parent artery at the aneurysm location |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pipeline Embolization Device (PED) | Device | 1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With the Occurrence of Major Ipsilateral Stroke or Neurologic Death and Occurrence of Ipsilateral Stroke or Neurologic Death. | The number of participants with occurrence of major ipsilateral stroke or neurologic death after PED placement at 180-days and the occurrence of ipsilateral stroke or neurologic death after Pipeline Embolization Devices (PED) placement at 5-years. | 180-days and 5-years |
| Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) Without Major Parent Artery Stenosis. | The count of Intracranial Aneurysms (IA) evaluated as completely occluded (defined as Raymond Grade 1) without major parent artery stenosis at 180 days. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows: Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 1 Year | The count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) (defined as Raymond-Roy grade 1) 1 year follow-up visit. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows: Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac |
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Inclusion Criteria:
Age 21 to 75 years, inclusive
Patient has a single target IA in the anterior or posterior circulation that:
a) Is located in the following regions of the internal carotid artery: i. Paraophthalmic (including paraclinoid, ophthalmic and hypophyseal segments) ii. Cavernous iii. Petrous
b) Has a neck >4 mm or no discernible neck AND a size (maximum fundus diameter) >10 mm
c) Has a parent vessel with diameter 2.5 - 5.0 mm distal/proximal to the target IA
Subject has provided written informed consent using the Institutional Review Board (IRB)-approved consent form
Subject has the necessary mental capacity to participate and is willing and able to comply with protocol requirements
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tibor Bescke, MD | New York University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | United States | ||
| Rush University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27739944 | Derived | Becske T, Potts MB, Shapiro M, Kallmes DF, Brinjikji W, Saatci I, McDougall CG, Szikora I, Lanzino G, Moran CJ, Woo HH, Lopes DK, Berez AL, Cher DJ, Siddiqui AH, Levy EI, Albuquerque FC, Fiorella DJ, Berentei Z, Marosfoi M, Cekirge SH, Nelson PK. Pipeline for uncoilable or failed aneurysms: 3-year follow-up results. J Neurosurg. 2017 Jul;127(1):81-88. doi: 10.3171/2015.6.JNS15311. Epub 2016 Oct 14. | |
| 26162031 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pipeline | Placement of Pipeline Embolization Device in the parent artery at the aneurysm location Pipeline Embolization Device (PED): 1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pipeline | Placement of Pipeline Embolization Device in the parent artery at the aneurysm location Pipeline Embolization Device (PED): 1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach |
| 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 | Number of Participants With the Occurrence of Major Ipsilateral Stroke or Neurologic Death and Occurrence of Ipsilateral Stroke or Neurologic Death. | The number of participants with occurrence of major ipsilateral stroke or neurologic death after PED placement at 180-days and the occurrence of ipsilateral stroke or neurologic death after Pipeline Embolization Devices (PED) placement at 5-years. | Patients treated with one or more Pipeline Embolization Devices. | Posted | Count of Participants | Participants | 180-days and 5-years |
|
Cumulative incidence rate of adverse events observed at 5 years.
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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 | Pipeline | Placement of Pipeline Embolization Device in the parent artery at the aneurysm location Pipeline Embolization Device (PED): 1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebral Haemorrhage | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Darren LaCour | Medtronic | 949-680-1274 | darren.j.lacour@medtronic.com |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 1 Year |
| Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 3 Year Follow-up | The count of Intracranial Aneurysms (IA) evaluated as completely occluded (100%) (defined as Raymond-Roy grade 1) at 3 year follow-up. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows: Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac | 3 years |
| Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 5 Years | The count of Intracranial Aneurysms (IA) evaluated as completely occluded (100%) (defined as Raymond-Roy grade 1) at 5-year follow-up. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows: Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac | 5 years |
| Stenosis of the Parent Artery in PED at 3 Years | Parent artery stenosis (narrowing of the artery from which the aneurysm arises) at 3-year follow-up | 3-years |
| Stenosis of the Parent Artery in PED at 5 Years | Parent artery stenosis at 5-year follow-up | 5-years |
| Number of Participants With Device-Related Adverse Events at 3 Years | Number of participants with incidence of device-related adverse events at 3 year follow-up | 3 years |
| Number of Participants With Device-related Adverse Events at 5 Years | Subjects Observed with Device Related Adverse Events 5 years after Pipeline Placement | 5 years |
| Chicago |
| Illinois |
| United States |
| Central Du Page Hospital | Winfield | Illinois | United States |
| Mayo Clinic | Rochester | Minnesota | United States |
| Washington University St. Louis | St Louis | Missouri | United States |
| University of Buffalo | Buffalo | New York | United States |
| New York University | New York | New York | United States |
| Stony Brook University | Stony Brook | New York | United States |
| National Institute of Neurosurgery | Budapest | Hungary |
| Hacettepe University | Ankara | Turkey (Türkiye) |
| Derived |
| Sahlein DH, Fouladvand M, Becske T, Saatci I, McDougall CG, Szikora I, Lanzino G, Moran CJ, Woo HH, Lopes DK, Berez AL, Cher DJ, Siddiqui AH, Levy EI, Albuquerque FC, Fiorella DJ, Berentei Z, Marosfoi M, Cekirge SH, Kallmes DF, Nelson PK. Neuroophthalmological outcomes associated with use of the Pipeline Embolization Device: analysis of the PUFS trial results. J Neurosurg. 2015 Oct;123(4):897-905. doi: 10.3171/2014.12.JNS141777. Epub 2015 Jul 10. |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) Without Major Parent Artery Stenosis. | The count of Intracranial Aneurysms (IA) evaluated as completely occluded (defined as Raymond Grade 1) without major parent artery stenosis at 180 days. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows: Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac | A total of 104 participants and 106 intracranial aneurysms treated with the Pipeline Embolization Device were included in the primary effectiveness endpoint analysis. | Posted | Count of Units | Fully Occluded Intracranial Aneurysms | 180 days | Fully Occluded Intracranial Aneurysms | Fully Occluded Intracranial Aneurysms |
|
|
|
|
| Secondary | Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 1 Year | The count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) (defined as Raymond-Roy grade 1) 1 year follow-up visit. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows: Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac | Pipeline treated subjects with observable data at 1 year | Posted | Count of Units | Target Intracranial Aneurysms | 1 Year | Target Intracranial Aneurysms | Target Intracranial Aneurysms |
|
|
|
| Secondary | Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 3 Year Follow-up | The count of Intracranial Aneurysms (IA) evaluated as completely occluded (100%) (defined as Raymond-Roy grade 1) at 3 year follow-up. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows: Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac | Pipeline treated Subjects with observable data at 3 years | Posted | Count of Units | Target Intracranial Aneurysms | 3 years | Target Intracranial Aneurysms | Target Intracranial Aneurysms |
|
|
|
| Secondary | Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 5 Years | The count of Intracranial Aneurysms (IA) evaluated as completely occluded (100%) (defined as Raymond-Roy grade 1) at 5-year follow-up. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows: Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac | Pipeline treated subjects with observable data at 5 years | Posted | Count of Units | Target Intracranial Aneurysms | 5 years | Target Intracranial Aneurysms | Target Intracranial Aneurysms |
|
|
|
| Secondary | Stenosis of the Parent Artery in PED at 3 Years | Parent artery stenosis (narrowing of the artery from which the aneurysm arises) at 3-year follow-up | Subjects that completed imaging at the 3-year follow-up were included in the parent artery stenosis analysis. | Posted | Count of Units | Parent Artery Assessments | 3-years | Parent Artery Assessments | Parent Artery Assessments |
|
|
|
| Secondary | Stenosis of the Parent Artery in PED at 5 Years | Parent artery stenosis at 5-year follow-up | Subjects that completed imaging at the 5-year follow-up were included in the parent artery stenosis analysis. | Posted | Count of Units | Parent Artery Assessments | 5-years | Parent Artery Assessments | Parent Artery Assessments |
|
|
|
| Secondary | Number of Participants With Device-Related Adverse Events at 3 Years | Number of participants with incidence of device-related adverse events at 3 year follow-up | Posted | Count of Participants | Participants | 3 years |
|
|
|
| Secondary | Number of Participants With Device-related Adverse Events at 5 Years | Subjects Observed with Device Related Adverse Events 5 years after Pipeline Placement | Subjects Observed with Device Related Adverse Events 5 years after Pipeline Placement | Posted | Count of Participants | Participants | 5 years |
|
|
|
| 55 |
| 107 |
| 74 |
| 107 |
| Headcahe | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cerebral Ischaemia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Liird nerve disorder | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ischaemia stroke | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Carotid artery occlusion | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cerebral artery embolism | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dimentia alzheimer's type | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vith nerve disorder | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Wolff-parkinson white syndrome | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Amaurosis fugax | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ophthalmoplegia | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Retinal artery embolism | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Diverticulitis intestinal haemorrhagic | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Oesophageal spasm | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Aneurysm | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Intermittent claudification | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Arterial injury | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Aneurysm repair | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Arterial aneurysm repair | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Intra-cerebral aneurysm repair | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Cholecystitis infective | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Creast cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
|
| Catheter site discharge | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Death | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Intervertebral disk degeneration | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Visual Impairment | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Title | Measurements |
|---|---|
|
| Stenosis >75% |
|
| Indeterminate |
|
| Title | Measurements |
|---|---|
|
| Stenosis >75% |
|
| Indeterminate |
|