AngioSculpt® Coronary Bifurcation Study
Completed · Not applicable
Conditions studied: Coronary Artery Disease, Myocardial Ischemia
In brief
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.
Key facts
- Study ID
- NCT00686647
- Run by
- AngioScore, Inc.
- People needed
- 93
- Starts
- 2008-04-01
- Expected to finish
- 2011-01-01
- Last updated by the study team
- 2011-08-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
Where it is running
- Columbia University Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.