Status:
COMPLETED
AngioSculpt® Coronary Bifurcation Study
Lead Sponsor:
AngioScore, Inc.
Conditions:
Coronary Artery Disease
Myocardial Ischemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 arteries.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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 coronary artery bypass grafting (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 aspirin or Clopidogrel/Ticlopidine
- Severe renal failure with creatinine \>2.0 mg/dL
- Untreated pre-procedural hemoglobin \<10 g/dL
- Coagulopathy manifested by platelet count \<100,000 or International Normalized ratio (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 (ISR))
- Target bifurcation lesion within a surgical conduit (e.g. saphenous vein or internal mammary)
- Target lesion demonstrating severe dissection prior to planned deployment of the AngioSculpt device
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00686647
Start Date
April 1 2008
End Date
January 1 2011
Last Update
August 10 2011
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032