Sprinter Legend Balloon Catheter

Study Overview
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Brief Summary
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Open label, single-arm trial to study the safety and effectiveness of the Sprinter Legend 1.25 mm angioplasty balloon.

Detailed Description
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The study examines acute outcomes when the Sprinter Legend 1.25mm balloon catheter is used for enlarging coronary luminal diameters during PCI procedures.

Official Title
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Evaluation of Acute Safety and Efficacy of the Medtronic Sprinter Legend 1.25mm Balloon Dilation Catheter Utilized for Enlarging Coronary Luminal Diameters During PCI Procedures

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Percutaneous Coronary Intervention
* Device: Sprinter Legend 1.25mm Balloon Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is greater than18 years of age and able to give informed consent. Patient with stenotic lesions in coronary arteries or bypass graft stenosis that are suitable for percutaneous coronary intervention (PCI). The patient has single or multiple vessel coronary artery disease and clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, and/or a positive functional study. Female patients of childbearing potential must have a negative pregnancy test within seven (7) days before the procedure. Patient or patient's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective investigational site. Patients with symptomatic ischemic heart disease due to stenotic lesions in coronary arteries or bypass graft stenosis that are amenable to percutaneous treatment. Exclusion Criteria: A known hypersensitivity or contraindication to aspirin, heparin, or bivalirudin, anti-platelet medications, or sensitivity to contrast media, which cannot be adequately pre-medicated. A serum creatinine level > 2.0 mg/dl within seven days prior to index procedure. Evidence of an acute myocardial infarction within 72 hours of the intended index procedure (defined as: Q wave myocardial infarction or non-Q wave myocardial infarction having creatine kinase myocardial-band isoenzyme (CK-MB) or troponin elevated above the Institution's upper limit of normal). During the index procedure, the target lesion requires additional treatment with a cutting balloon, any artherectomy, any laser, thrombectomy, etc. History of stroke or transient ischemic attack (TIA) within the prior 6 months. Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months. History of bleeding diathesis or coagulopathy or will refuse blood transfusions.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trial Arm<br>All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous treatment. | Procedure: Percutaneous Coronary Intervention<br>* Balloon angioplasty of a severely stenotic coronary lesion with the Sprinter Legend 1.25mm Balloon.<br>Device: Sprinter Legend 1.25mm Balloon Catheter<br>* Balloon Angioplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success | Procedural Success defined as delivery of the balloon to the target lesion, no evidence of perforation or dissection and restoration of normal blood flow at the end of the procedure. | 1-3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardic Events (MACE) | Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction, emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods. | 1-3 days | 
| Vessel Perforation (Clinical) | Clinical vessel perforation is classified as requring additional treatment, or resulting in significant pericardial effusion, acute closure, myocardial infarction, or death. | 1-3 days | 
| Device Success | Device Success defined as successful delivery of the balloon to the target lesion, dilatation of the lesion using the study device, and no evidence of arterial perforation, dissection, arrhythmias, or reduction in blood flow. | 1-3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Balloon, Angioplasty, Coronary Artery, PCI, PTCA, Heart Disease, Myocardial Ischemia