Coronary Artery Disease
Conditions
Keywords
Balloon, Angioplasty, Coronary Artery, PCI, PTCA, Heart Disease, Myocardial Ischemia
Brief summary
Open label, single-arm trial to study the safety and effectiveness of the Sprinter Legend 1.25 mm angioplasty balloon.
Detailed description
The study examines acute outcomes when the Sprinter Legend 1.25mm balloon catheter is used for enlarging coronary luminal diameters during PCI procedures.
Interventions
PROCEDUREPercutaneous Coronary Intervention
Balloon angioplasty of a severely stenotic coronary lesion with the Sprinter Legend 1.25mm Balloon.
DEVICESprinter Legend 1.25mm Balloon Catheter
Balloon Angioplasty
Sponsors
Medtronic Vascular
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Success | 1-3 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardic Events (MACE) | 1-3 days | 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. |
| Vessel Perforation (Clinical) | 1-3 days | Clinical vessel perforation is classified as requring additional treatment, or resulting in significant pericardial effusion, acute closure, myocardial infarction, or death. |
| Device Success | 1-3 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Balloon Angioplasty All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon. | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | Balloon Angioplasty |
|---|---|
| Age Continuous | 67 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 51 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 51 |
| serious Total, serious adverse events | 6 / 51 |
Outcome results
Primary
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.
Time frame: 1-3 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balloon Angioplasty | Procedural Success | 100 Percent of Participants |
Secondary
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.
Time frame: 1-3 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balloon Angioplasty | Device Success | 100 Percent of Participants |
Secondary
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.
Time frame: 1-3 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balloon Angioplasty | Major Adverse Cardic Events (MACE) | 2.0 Percent of Participants |
Secondary
Vessel Perforation (Clinical)
Clinical vessel perforation is classified as requring additional treatment, or resulting in significant pericardial effusion, acute closure, myocardial infarction, or death.
Time frame: 1-3 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balloon Angioplasty | Vessel Perforation (Clinical) | 0 Percent of Participants |