Sprinter Legend Balloon Catheter
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
1 other identifier
interventional
51
1 country
1
Brief Summary
Open label, single-arm trial to study the safety and effectiveness of the Sprinter Legend 1.25 mm angioplasty balloon.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable coronary-artery-disease
Started Aug 2009
Shorter than P25 for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedFirst Posted
Study publicly available on registry
August 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedResults Posted
Study results publicly available
April 14, 2011
CompletedOctober 26, 2011
October 1, 2011
5 months
July 14, 2009
January 27, 2011
October 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Major Adverse Cardic Events (MACE)
1-3 days
Vessel Perforation (Clinical)
1-3 days
Device Success
1-3 days
Study Arms (1)
Trial Arm
EXPERIMENTALAll patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous treatment.
Interventions
Balloon angioplasty of a severely stenotic coronary lesion with the Sprinter Legend 1.25mm Balloon.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Scripps Green Hospital
La Jolla, California, 92037, United States
Related Publications (1)
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.
PMID: 21351225RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- K. Bogdanovich
- Organization
- Medtronic Cardiovascular
Study Officials
- PRINCIPAL INVESTIGATOR
David Kandzari, MD
Scripps Green Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2009
First Posted
August 18, 2009
Study Start
August 1, 2009
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
October 26, 2011
Results First Posted
April 14, 2011
Record last verified: 2011-10