Advertisement

Topics

AngioSculpt® Coronary Bifurcation Study

2014-07-24 14:17:33 | BioPortfolio

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)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:17:33-0400

Clinical Trials [4082 Associated Clinical Trials listed on BioPortfolio]

Post Market Surveillance of SeQuent Please Neo With Scoring Balloon

The main objective of the Indian SeQuent® Please Neo post market surveillance is to assess the clinical suitability of the combination of pre-dilatation using the NSE Alpha scoring balloo...

Scoreflex NC - Scoring PTCA Catheter

A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device procedural success of the Scoreflex NC Scoring PTCA catheters in s...

Advance® 18PTX® Balloon Catheter Study

The Advance® 18 PTX® Balloon Catheter study is a clinical trial to study the safety and effectiveness of the Advance 18® PTX® Balloon Catheter in the treatment of lesions in the superf...

The Paclitaxel-Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) - Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions

The aim of the study is to assess the safety and efficacy of a Paclitaxel-eluting PTCA-balloon in combination with bare-metal stenting for treatment of chronic total occlusions in native c...

BEnefit of Arterial Preparation by LONGitudinal Scoring

The purpose of the artery preparation concept is to perform regular longitudinal micro-incisions on the inner side of the artery ("scoring") and therefore promote a regular expansion of at...

PubMed Articles [17727 Associated PubMed Articles listed on BioPortfolio]

Percutaneous coronary intervention with drug-coated balloon-only strategy in stable coronary artery disease and in acute coronary syndromes: An all-comers registry study.

The aim of this single center all-comers retrospective registry study was to assess the efficacy and safety of percutaneous coronary intervention (PCI) using drug-coated balloon (DCB) in de novo lesio...

The Need for Multiple Bypass Grafts in Repair of Right Coronary Artery to Coronary Sinus Fistulae.

Coronary artery fistulae (CAF) are rare anomalies with controversial management strategies. The two main treatment options include either surgical repair or catheter embolization. Herein, we report su...

Historical Milestones in the Management of Stable Coronary Artery Disease over the Last Half Century.

Coronary revascularization for coronary artery disease dates to the introduction of coronary bypass surgery by Favaloro in 1967 and coronary angioplasty by Gruentzig in 1977 and first published in 196...

Coronary Artery Calcium Scoring: Current Status and Review of Literature.

Coronary artery calcium is a marker of overall atherosclerotic plaque burden, corresponding to approximately 20% overall atherosclerotic plaque burden. Coronary artery calcium screening, most commonly...

Coronary artery calcium scoring: Its practicality and clinical utility in primary care.

Coronary artery calcium scoring is useful as a risk-stratification tool in coronary artery disease, and it outperforms other risk-assessment methods. American College of Cardiology/American Heart Asso...

Medical and Biotech [MESH] Definitions

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.

Dilation of an occluded coronary artery (or arteries) by means of a balloon catheter to restore myocardial blood supply.

Dilatation of an occluded coronary artery (or arteries) by means of a balloon catheter to restore myocardial blood supply.

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.

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.

More From BioPortfolio on "AngioSculpt® Coronary Bifurcation Study"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Cardiology
Cardiology is a specialty of internal medicine.  Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...


Searches Linking to this Trial