A Non-Randomized, Unblinded, Singlecenter, First-in-Man, Prospective Forward-Looking (FL) Intravascular Ultrasound (IVUS) Catheter Safety and Feasibility Study in Patients Scheduled for Coronary Stenting.

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Stable patients scheduled to undergo single vessel coronary stenting due to symptoms of stable angina.
Patient must be between the ages of 21 and 85 years old.
Patient must be able to read, understand and sign the informed consent document before the planned procedure.

Exclusion Criteria

-. Planned surgical percutaneous coronary intervention within 30 days.
-. Severe vascular disease, tortuosity, or angiographic evidence of thrombus.
-. A recent MI
-. Braunwald classification of unstable angina AI, II and III. (see Appendix 3)
-. Mainstem leasion
-. Ostial lesions.
-. Bifurcation lesions double guide wires.
-. Total occlusions.
-. Left ventricular ejection fraction (LVEF) of less than 30%
-. Clinically significant valvular disease.
-. CVA.
-. Persistent, uncontrolled hypertension
-. Hemodynamic instability
-. Significant (as determined by the investigator) gastro-intestinal bleeding in the past 3 months.
-. Contra-indication to antithrombotic regimen of anticoagulation therapy.
-. Patient is known that susceptible to vascular spasm.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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