NCT00961311CompletedNot Applicable
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
Medtronic Vascular2 sites in 1 country51 target enrollmentStarted: August 1, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 51
- Locations
- 2
- Primary Endpoint
- Procedural Success
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Procedural Success
Time Frame: 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 Outcomes
- Major Adverse Cardic Events (MACE)(1-3 days)
- Vessel Perforation (Clinical)(1-3 days)
- Device Success(1-3 days)
Investigators
Study Sites (2)
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