Back to resultsSprinter Legend Balloon Catheter
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Percutaneous Coronary Intervention
Sprinter Legend 1.25mm Balloon Catheter
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Balloon, Angioplasty, Coronary Artery, PCI, PTCA, Heart Disease, Myocardial Ischemia
Eligibility Criteria
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.
Sites / Locations
- Scripps Green Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Trial Arm
Arm Description
All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous treatment.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Vessel Perforation (Clinical)
Clinical vessel perforation is classified as requring additional treatment, or resulting in significant pericardial effusion, acute closure, myocardial infarction, or death.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00961311
Brief Title
Sprinter Legend Balloon Catheter
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Vascular
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Balloon, Angioplasty, Coronary Artery, PCI, PTCA, Heart Disease, Myocardial Ischemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trial Arm
Arm Type
Experimental
Arm Description
All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous treatment.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Coronary Intervention
Intervention Description
Balloon angioplasty of a severely stenotic coronary lesion with the Sprinter Legend 1.25mm Balloon.
Intervention Type
Device
Intervention Name(s)
Sprinter Legend 1.25mm Balloon Catheter
Intervention Description
Balloon Angioplasty
Primary Outcome Measure Information:
Title
Procedural Success
Description
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
Secondary Outcome Measure Information:
Title
Major Adverse Cardic Events (MACE)
Description
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
Title
Vessel Perforation (Clinical)
Description
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
Title
Device Success
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kandzari, MD
Organizational Affiliation
Scripps Green Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Green Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21351225
Citation
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.
Results Reference
result
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Sprinter Legend Balloon Catheter
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