The purpose of this study is to evaluate a new angioplasty catheter, AngioSculpt® for the
treatment of bifurcation lesions (blockages occurring at branch points) in coronary
Background: Bifurcation lesions, which consist of a narrowing occurring at branch points of
coronary arteries, typically involve both the main branch (parent vessel) and an adjacent
side branch. These lesions pose a particularly challenging situation for angioplasty
procedures due to the difficulty of covering both branches with stents and a higher rate of
recurrence (restenosis). A new angioplasty scoring balloon catheter (AngioSculpt®) has
recently been approved for the treatment of narrowings in coronary arteries. The
AngioSculpt® catheter incorporates a nitinol device that consists of spiral wires that wrap
around the balloon catheter. As the balloon inflates, the spiral wires score the lesion
allowing the balloon to be more stable (avoid slippage) and may enlarge the narrowed
sections of the artery with less pressure or risk of dissection (uncontrolled tearing of the
inner lining of the artery wall commonly seen with conventional balloons).
Study Purpose: To demonstrate the safety and efficacy of the AngioSculpt® used in
conjunction with coronary stents (implantable wire mesh tubes for scaffolding blocked
arteries) for the treatment of coronary artery bifurcation narrowings and to compare these
results with the historical outcomes associated with the use of conventional balloons and
stents in the treatment of bifurcation lesions.
Study Design: A prospective, multi-center, non-randomized, single-arm study with results
compared to a literature search derived historical control for conventional balloon
angioplasty (OPC - Objective Performance Criteria). The intent of this study is to enroll
and treat 100 patients at 8 U.S. interventional cardiology programs with clinical follow-up
planned at 30 days and 9 months following the procedure.
- At least 18 years of age and able to give informed consent.
- Patients with significant (> 50% diameter stenosis) native coronary artery disease
involving a bifurcation and the ostium of the side branch vessel (Medina class (x, x,
1)) including stable or unstable angina and silent ischemia.
- Patients with lesions suitable for percutaneous coronary intervention (PCI).
- Concomitant use of Rotablator, Cutting Balloon, or investigational coronary devices.
- Additional planned coronary interventions for a non-target lesion within 9 months of
the study procedure.
- Left ventricular ejection fraction < 35%
- Patients refusing or not candidates for emergency CABG surgery
- Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)
- Patients who are not candidates for chronic treatment with ASA or
- Severe renal failure with creatinine >2.0 mg/dL
- Untreated pre-procedural hemoglobin <10 g/dL
- Coagulopathy manifested by platelet count <100,000 or INR >2.0 (INR is only required
in patients who have taken warfarin within 2 weeks of enrollment)
- Women who are known or suspected to be pregnant
- Patients in cardiogenic shock
- Acute myocardial infarction (MI) within the past 72 hours, and/or elevated CPK (and
abnormal Troponin-I) at the time of enrollment
- Patients with a life expectancy of less than 1 year
- Target main branch vessel < 2.5 mm in diameter
- Target main branch lesion > 30 mm in length
- Intended use of a bare metal stent (BMS) in the main branch
- Target side branch vessel < 2.0 mm in diameter
- Target side branch lesion > 15 mm in length
- Target bifurcation angle > 90º (distal angle)
- Totally obstructed target coronary arteries (TIMI 0 or 1 flow)
- Target bifurcation lesion within a previously placed stent (i.e. in-stent restenosis
- Target bifurcation lesion within a surgical conduit (e.g. saphenous vein or internal
- Target lesion demonstrating severe dissection prior to planned deployment of the
- Unprotected Left Main diameter stenosis ≥ 50%
- Visible thrombus (by angiography) at target lesion site
- Coronary spasm in the absence of a significant stenosis
- Patients who are concurrently participating in an investigational study when such
participation could confound the treatment or outcomes of this study