Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2009-08-31
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Trial Arm
All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous treatment.
Percutaneous Coronary Intervention
Balloon angioplasty of a severely stenotic coronary lesion with the Sprinter Legend 1.25mm Balloon.
Sprinter Legend 1.25mm Balloon Catheter
Balloon Angioplasty
Interventions
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Percutaneous Coronary Intervention
Balloon angioplasty of a severely stenotic coronary lesion with the Sprinter Legend 1.25mm Balloon.
Sprinter Legend 1.25mm Balloon Catheter
Balloon Angioplasty
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Medtronic Vascular
INDUSTRY
Responsible Party
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Principal Investigators
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David Kandzari, MD
Role: PRINCIPAL_INVESTIGATOR
Scripps Green Hospital
Locations
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Scripps Green Hospital
La Jolla, California, United States
Countries
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References
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Kandzari DE, Zankar AA, Teirstein PS, Brilakis ES, Banerjee S, Price MJ, Stinis CT, Hudson PA, Dahle TG, Eng M, Brown R, Ferguson A, Addo TA, Popma JJ. Clinical outcomes following predilation with a novel 1.25-mm diameter angioplasty catheter. Catheter Cardiovasc Interv. 2011 Mar 1;77(4):510-4. doi: 10.1002/ccd.22734. Epub 2010 Nov 4.
Other Identifiers
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IP-111
Identifier Type: -
Identifier Source: org_study_id