Clinical trial NCT00961311: 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
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Balloon
Angioplasty
Coronary Artery
PCI
PTCA
Heart Disease
Myocardial Ischemia
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2009-08-18
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Procedural Success
timeFrame: 1-3 days
Secondary outcomes:
measure: Major Adverse Cardic Events (MACE)
timeFrame: 1-3 days
measure: Vessel Perforation (Clinical)
timeFrame: 1-3 days
measure: Device Success
timeFrame: 1-3 days
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
Study officials:
affiliation: Scripps Green Hospital
name: David Kandzari, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.