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To determine whether the Boston Scientific nitinol drug-eluting stent shows acceptable performance at 9 months when treating Superficial Femoral (SFA) and/or Proximal Popliteal Artery (PPA) lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test device arm (DES SFA) | Experimental | Patients in this arm will receive the study device: the Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA) | Device | Drug-eluting SFA self-expanding stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Patency | Primary patency of target lesion at 9-months assessed by duplex ultrasound (DUS) as adjudicated by an independent core laboratory. Primary Patency: percentage (%) of lesions (target stented segments) that reach endpoint without a hemodynamically significant stenosis on DUS and without target lesion revascularization (TLR) or, bypass of the target lesion. | 9-months |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Composite of Major Adverse Events | The composite rate of Major Adverse Events (MAEs) is defined as all causes of death through 1 month, target limb major amputation through 9 months and/or target lesion revascularization through 9 months. | 9 months |
Inclusion Criteria:
Subjects age 18 and older
Subject (or Legal Guardian if applicable) has signed the consent form and is willing and able to provide consent before any study-specific tests or procedures are performed and agrees to attend all required follow-up visits
Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4
Stenotic, restenotic (from angioplasty only, previous treatment with drug coated balloon is not allowed) or occlusive lesion(s) located in the native superficial femoral artery or proximal popliteal artery:
Degree of stenosis ≥70% by visual angiographic assessment
Vessel diameter ≥ 4 and ≤ 6mm
Total lesion length (or series of lesions) ≥30 mm and ≤110 mm
Target lesion located at least three centimeters above the inferior edge of the femur
Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (<50% stenosis) to the ankle or foot
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Müller-Hülsbeck, Prof. | Ev. Luth. Diakonissenanstalt Flensburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Prince Alfred Hospital | Camperdown | Australia | ||||
| Prince of Wales Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21953370 | Background | Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Zeller T, Roubin GS, Burket MW, Khatib Y, Snyder SA, Ragheb AO, White JK, Machan LS; Zilver PTX Investigators. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011 Oct 1;4(5):495-504. doi: 10.1161/CIRCINTERVENTIONS.111.962324. Epub 2011 Sep 27. | |
| 27193308 |
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There were 57 subjects enrolled at 14 investigative centers in Europe, Australia and New Zealand. The first subject was enrolled on 23 August 2013. Enrollment was completed on 03 March 2014, when the last subject was enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Device Arm (DES SFA, ELUVIAâ„¢) | All patients in this arm were treated with the study device. The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA, ELUVIAâ„¢) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Randwick |
| Australia |
| Allgemeines Krankenhaus AKH | Vienna, Austria | Austria |
| AZ Sint-Blasius | Dendermonde | 9200 | Belgium |
| Ziekenhuis Oost Limburg | Genk | Belgium |
| Regionaal Ziekenhuis Heilig Hart Tienen | Tienen | 3300 | Belgium |
| Universitäts-Herzzentrum Freiburg Bad Krozingen GmbH | Bad Krozingen | Germany |
| Ev. Luth. Diakonissenanstalt Flensburg | Flensburg | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | Germany |
| Universität Leipzig | Leipzig | Germany |
| Auckland City Hospital | Auckland | New Zealand |
| Braemar Hospital | Hamilton | New Zealand |
| Middlemore Hospital | Otahuhu | New Zealand |
| Derived |
| Muller-Hulsbeck S, Keirse K, Zeller T, Schroe H, Diaz-Cartelle J. Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther. 2016 Oct;23(5):701-7. doi: 10.1177/1526602816650206. Epub 2016 May 18. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Device Arm (DES SFA, ELUVIAâ„¢) | All patients in this arm were treated with the study device. The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA, ELUVIAâ„¢) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| General Medical History | Count of Participants | Participants |
|
| 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 | Primary Patency | Primary patency of target lesion at 9-months assessed by duplex ultrasound (DUS) as adjudicated by an independent core laboratory. Primary Patency: percentage (%) of lesions (target stented segments) that reach endpoint without a hemodynamically significant stenosis on DUS and without target lesion revascularization (TLR) or, bypass of the target lesion. | 54 subjects were included in this analysis - one 9 month visit was completed too early, outside the protocol defined visit window, one subject withdrew consent at the 1 month follow-up visit and one subject did not complete the 9 month follow up visit due to site relocation. | Posted | Number | 90% Confidence Interval | percentage of lesions | 9-months | Lesions | Lesions |
|
|
| |||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Composite of Major Adverse Events | The composite rate of Major Adverse Events (MAEs) is defined as all causes of death through 1 month, target limb major amputation through 9 months and/or target lesion revascularization through 9 months. | 55 subjects were included in this analysis - one subject withdrew consent at the 1 month follow-up visit and one subject did not complete the 9 month follow up visit due to site relocation. | Posted | Number | 95% Confidence Interval | percentage of participants | 9 months |
|
|
3 years +/- 30 days visit window from the date of the index procedure.
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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 | Test Device Arm (DES SFA, ELUVIAâ„¢) | All patients in this arm were treated with the study device. The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA, ELUVIAâ„¢) | 2 | 57 | 34 | 57 | 36 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Femoral artery stenosis | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Arterial thrombosis limb | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Arterial stenosis limb | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Femoral artery occlusion | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Arterial occlusive disease | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Arterial spasm | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Arteriovenous fistula | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Iliac artery occlusion | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Iliac artery stenosis | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Peripheral artery aneurysm | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Venous stenosis | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Arterial injury | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Graft thrombosis | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Vascular graft complication | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Dupuytren's contracture | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Abdominal wall haemorrhage | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Metastatic squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Renal artery occlusion | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cardiac death | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Catheter site haematoma | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Femoral arterial stenosis | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Femoral artery occlusion | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Iliac artery stenosis | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Arterial stenosis limb | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Arterial thrombosis limb | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Catheter site haematoma | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Catheter site haemorrhage | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| General symptom | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Abnormal sensation in eye | Eye disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hyphaema | Eye disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Tooth disorder | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Abdominal wall haematoma | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Nail injury | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Post procedural oedema | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Tendon injury | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Deafness bilateral | Ear and labyrinth disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Prostatism | Reproductive system and breast disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
Institution and Investigator shall have the right to publish the Results, provided that before publishing, Institution and Investigator shall submit copies of any proposed publication or presentation to Sponsor for review at least sixty (60) days in advance of submission for publication or presentation to a publisher or other third party. Sponsor reserves the right to delete any Confidential Information or other proprietary information of Sponsor from the proposed publication or presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lieve Cornelis, Clinical Trial Manager | Boston Scientific | + 32 476-840-183 | Lieve.Cornelis@bsci.com |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| Other |
|
| Belgium |
|
| Australia |
|
| Germany |
|
| History of Hyperlipidemia requiring medication |
|
| History of Hypertension requiring medication |
|
| History of Chronic Obstructive Pulmonary Disease |
|
| History of Coronary Artery Disease (CAD) |
|
| History of Myocardial Infarction (MI) |
|
| History of Congestive Heart Failure (CHF) |
|
| History of Percutaneous Coronary Intervention(PCI) |
|
| History of Coronary Artery Bypass Graft (CABG) |
|
| Stable Angina |
|
| History of Transient Ischemic Attacks (TIA) |
|
| History of Cerebrovascular Accident (CVA) |
|
| History of Renal Insufficiency |
|
| History of Renal Percutaneous Intervention |
|
| History of Peripheral Vascular Surgery |
|
| History of Peripheral Endovascular Intervention |
|
| History of Claudication |
|
|