Phase 3 N=60 Evaluation of Coronary Luminal Diameter Enlargement With Emerge™ 1.20 mm PTCA Dilatation Catheter
Coronary Artery Disease
Primary: Device Procedural Success — 98.3 percentage of participants
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Phase 2 N=10 CorPath™ 200: Robotically-Assisted Percutaneous Coronary Intervention (PCI)
Coronary Artery Disease
Primary: Clinical Procedural Success — 100 percentage of participants
N/A N=96 Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions
Coronary Artery Disease
Primary: Delta Cardiac Troponin I (ΔcTnI) — 0.04; 0.19 ng/mL
N/A N=200 Hybrid Coronary Revascularization Trial
Coronary Artery Disease
Primary: Major Adverse Coronary and Cerebrovascular Events (MACCE) — 0.130; 0.111 MACCE Event Rate per Person-Year
Phase 4 N=208 Thromboaspiration in Patients With High Thrombotic Burden Undergoing Primary Percutaneous Coronary Intervention (PCI)
Primary PCI for STEMI
Primary: Rate of Complete ST-segment Elevation Resolution at 60 Minutes After the End of the Procedure — 38; 58 Participants
N/A N=3,000 Diagnostic Accuracy of Electrocardiogram for Acute Coronary Occlusion Resulting in Myocardial Infarction
Myocardial Infarction · Acute Coronary Syndrome · Coronary Artery Disease
Primary: The Sensitivity and Specificity of ECG for Acute Coronary Occlusion. — 767; 282; 16 Participants
N/A N=439 Evaluation Of New Onset Postoperative Atrial Fibrillation
Atrial Fibrillation New Onset
Primary: Primary Safety Endpoint — 3.9; 3.6 percentage of participants
N/A N=15 ECPR for Refractory Out-Of-Hospital Cardiac Arrest
Cardiac Arrest · Heart Arrest · Sudden Cardiac Arrest
Primary: Emergency Department Arrivals Under 30 Minutes — 5 Participants
N/A N=51 PCI Alternative Using Sustained Exercise
Cardiovascular Disease
Primary: Myocardial Perfusion Reserve — 2.76; 2.47; 2.82; 2.52 Ratio
N/A N=1,392 Computed Tomography Coronary Angiogram (CTCA) Versus Traditional Care in Emergency Department Assessment of Potential Acute Coronary Syndromes (ACS)
Chest Pain · Acute Coronary Syndrome · Acute Myocardial Infarction
Primary: Rates of Major Cardiac Events (AMI or Cardiac Death) Within 30 Days — 0; 0; 0; 10 Participants
N/A N=754 Post-Market CorPath Registry on the CorPath 200 System in Percutaneous Coronary Interventions
Coronary Artery Disease · Coronary Disease · Myocardial Ischemia
Primary: Number of Participants With Clinical Success — 723 Participants
Phase 4 N=22 EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders)
Lipid Disorder
Primary: Low-density Lipoprotein Cholesterol (LDL-C) Levels at Baseline and Day 30 — 110; 84.0 mg/dL
N/A N=222 EXPERT CTO: Evaluation of the XIENCE PRIME™ LL and XIENCE Nano™ Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions
Coronary Artery Disease (CAD) · Chronic Total Occlusion (CTO)
Primary: Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per ITT Set) — 39 Participants
Phase 4 N=390 Pre-hospital Administration of Thrombolytic Therapy With Urgent Culprit Artery Revascularization
Heart Disease · Myocardial Infarction · Acute Myocardial Infarction
Primary: Mortality at 30 Days — 1; 7; 3; 2 participants
N/A N=1,748 Rapid Assessment of Potential Ischaemic Heart Disease With CTCA
Acute Coronary Syndrome
Primary: All-cause Death or Subsequent Non-fatal Type 1 or Type 4b MI at One Year Measured as Time to First Such Event. — 51; 53 Participants
N/A N=3,691 Percutaneous Coronary Intervention (PCI) Outcomes in Community Versus Tertiary Settings
Coronary Artery Diseases
Primary: 30-day Composite Major Adverse Cardiac Event (MACE) — 256; 83 participants
N/A N=300 Electrophysiological Effects of Late PCI After MI
Cardiovascular Diseases · Heart Diseases · Myocardial Infarction
Primary: Short-termed Fractal Scaling Exponent (Alpha 1) — 0.01; -0.03 unit-less — p=0.34
N/A N=769 Early Discharge After Primary Percutaneous Coronary Intervention
ST Elevation Myocardial Infarction
Primary: All Cause Mortality and Readmission at 30 Days. — 16; 28 participants — p=<0.05
N/A N=2,103 The PRECISE Protocol: Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization
Coronary Artery Disease
Primary: Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease — 44; 118; 18; 12 number of events — p=<.001
N/A N=2,487 ILUMIEN IV: OPTIMAL Percutaneous Coronary Intervention (PCI)
Coronary Artery Disease · Coronary Stenosis · Atherosclerosis
Primary: Imaging Outcome (Powered): Minimal Stent Area (MSA) — 5.72; 5.36 mm^2 — p=<0.0001
N/A N=1,150 Randomized Endo-Vein Graft Prospective
Coronary Artery Bypass Grafting
Primary: Incidence of First MACE During Active Follow-up Period. — 80; 89 Participants — p=0.47
Phase 2 N=503 Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE)
Coronary Artery Disease (CAD)
Primary: Clinical Events Defined as the Composite of 30-day Death, MI, Repeat Revascularization, Catheter Thrombus, Stroke, Thrombocytopenia, Bailout Use of Glycoprotein IIb/IIIa…
N/A N=983 Safety Assessment of Angioplasty Procedures
Angiospastic; Disorder
Primary: Number of Major Adverse Cardiac Events (MACE) — 9; 6; 2; 119 Participants
N/A N=298 Hybrid Revascularization Observational Study
Coronary Artery Disease
Primary: Major Adverse Cardiac and Cerebrovascular Event (MACCE) — 23; 10; 3; 1 participants — p=0.80
N/A N=10,003 PROspective Multicenter Imaging Study for Evaluation of Chest Pain
Chest Pain
Primary: Time to Primary Endpoint — 1.0; 1.1; 1.2; 1.4 Percentage of participants with an event
N/A N=105 Oxford Acute Myocardial Infarction - Pressure-controlled Intermittent Coronary Sinus Occlusion
ST Elevation Myocardial Infarction
Primary: Index of Microcirculatory Resistance — 24.8; 45.0 units
Phase 4 N=100 Ad Hoc Percutaneous Coronary Intervention Study in Acute Coronary Syndrome Patients
Acute Coronary Syndrome
Primary: Inhibition of the P2Y12 Receptor at 2 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by P2Y12 Reaction Units (PRU) From VerifyNow™ — 98.4; 257.5 PRU…
N/A N=230 CorMatrix ECM for Carotid Repair Following Endarterectomy Registry
Carotid Stenosis
Primary: Carotid Procedure and Device Related Adverse Events to Determine Device Performance — 53; 10; 1; 2 Device related adverse events
N/A N=371 Dynamic Coronary Roadmap for Contrast Reduction
Coronary Artery Disease
Primary: Total Percutaneous Coronary Intervention (PCI) Iodinated Contrast Volume — 64.6; 90.8 ml
N/A N=5,179 International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)
Cardiovascular Diseases · Coronary Disease · Coronary Artery Disease
Primary: Primary Composite Outcome: Death From Cardiovascular Causes, Myocardial Infarction, or Hospitalization for Unstable Angina, Heart Failure, or Resuscitated Cardiac Arrest…