Sprinter Legend Balloon Catheter

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00961311
• Other study ID #: IP-111
• Status: Completed
• Phase: N/A
• First received: July 14, 2009
• Last updated: October 21, 2011
• Start date: August 2009
• Est. completion date: January 2010

Study information

• Verified date: October 2011
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Open label, single-arm trial to study the safety and effectiveness of the Sprinter Legend 1.25 mm angioplasty balloon.

Description:

The study examines acute outcomes when the Sprinter Legend 1.25mm balloon catheter is used for enlarging coronary luminal diameters during PCI procedures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Percutaneous Coronary Intervention
Balloon angioplasty of a severely stenotic coronary lesion with the Sprinter Legend 1.25mm Balloon.

Device:
• Sprinter Legend 1.25mm Balloon Catheter
Balloon Angioplasty

Locations

Country	Name	City	State
United States	Scripps Green Hospital	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Country where clinical trial is conducted

United States, 

References & 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 Ca — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	1-3 days	Yes
Secondary	Vessel Perforation (Clinical)	Clinical vessel perforation is classified as requring additional treatment, or resulting in significant pericardial effusion, acute closure, myocardial infarction, or death.	1-3 days	Yes
Secondary	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.	1-3 days	Yes