AngioSculpt® Coronary Bifurcation Study
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.
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 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.
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Coronary Artery Disease
Intervention
AngioSculpt® Scoring Balloon Catheter
Location
Columbia University Medical Center
New York
New York
United States
10032
Status
Active, not recruiting
Source
AngioScore, Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00686647
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Angioplasty, Balloon
Use of a balloon catheter for dilatation of an occluded artery. It is used in treatment of arterial occlusive diseases, including renal artery stenosis and arterial occlusions in the leg. For the specific technique of balloon dilatation in coronary arteries, ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY is available.
Angioplasty, Balloon, Coronary
Dilation of an occluded coronary artery (or arteries) by means of a balloon catheter to restore myocardial blood supply.
Angioplasty, Transluminal, Percutaneous Coronary
Dilatation of an occluded coronary artery (or arteries) by means of a balloon catheter to restore myocardial blood supply.
Catheterization, Swan-ganz
Placement of a balloon-tipped catheter into the pulmonary artery through the antecubital, subclavian, and sometimes the femoral vein. It is used to measure pulmonary artery pressure and pulmonary artery wedge pressure which reflects left atrial pressure and left ventricular end-diastolic pressure. The catheter is threaded into the right atrium, the balloon is inflated and the catheter follows the blood flow through the tricuspid valve into the right ventricle and out into the pulmonary artery.
Coronary Artery Bypass
Surgical therapy of ischemic coronary artery disease achieved by grafting a section of saphenous vein, internal mammary artery, or other substitute between the aorta and the obstructed coronary artery distal to the obstructive lesion.
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