Advertisement

Topics

Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions

2014-07-23 21:09:45 | BioPortfolio

Summary

This is a prospective, single-arm, multi-center study to evaluate the safety and performance of the OAS in treating de novo, severely calcified coronary lesions in adult subjects. Study is going to enroll up to 429 subjects in up to 50 U.S. study sites. The primary safety endpoint is 30-day MACE and primary efficacy endpoint is procedural success. All subjects will be treated with the orbital atherectomy system and adjunctive stent. All subjects will be followed in clinic at 30 days. Additionally, all subjects will have an annual phone call or clinical follow up at each anniversary until study is closed.

Study Design

Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Coronary Artery Disease (CAD) With Severely Calcified Lesions

Intervention

Diamondback 360 Orbital Atherecotmy System

Location

Desert Cardiology Center
Rancho Mirage
California
United States
92270

Status

Recruiting

Source

Cardiovascular Systems Inc

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:45-0400

Clinical Trials [3092 Associated Clinical Trials listed on BioPortfolio]

Comparison of Orbital Versus Rotational Atherectomy Effects On Coronary Microcirculation in PCI

The investigators hypothesize that the orbital atherectomy system (OAS), a newer generation atherectomy device, reduces the incidence of microcirculatory compromise as compared to older ge...

Evaluation of Treatment Strategies for Severe CaLcIfic Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug-Eluting StEnts: The ECLIPSE Trial

This trial will evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting st...

The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions

The purpose of this study is to assess the equivalence in safety and efficacy of the Endeavor Drug Eluting Coronary Stent System when compared to the Taxus Paclitaxel-Eluting Coronary Sten...

Diamondback in Peripheral Vascular Disease

This is a prospective, nonrandomized, single-arm study using CSI Orbital Atherectomy System in patients with PAD (total occlusions or significant stenosis). Patients will be enrolled if th...

Risk Factors of Individuals With Coronary Artery Disease

It would be useful to study coronary arteriovenous difference of various markers in patients who are undergoing coronary angiography for suspected coronary artery disease. Environmental an...

PubMed Articles [25094 Associated PubMed Articles listed on BioPortfolio]

Sex differences in impact of coronary artery calcification to predict coronary artery disease.

To assess sex-specific differences regarding use of conventional risks and coronary artery calcification (CAC) to detect coronary artery disease (CAD) using coronary CT angiography (CCTA).

Transradial versus transfemoral approach for diagnostic coronary angiography and percutaneous coronary intervention in people with coronary artery disease.

Cardiovascular disease (CVD) is the major cause of mortality worldwide. Coronary artery disease (CAD) contributes to half of mortalities caused by CVD. The mainstay of management of CAD is medical the...

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...

Orbital Atherectomy of Severely Calcified Unprotected Left Main Coronary Artery Disease: One-Year Outcomes.

We assessed the 1-year outcomes of patients who underwent orbital atherectomy for severely calcified unprotected left main coronary artery (ULMCA) disease.

Real-life characteristics and outcomes of patients who undergo percutaneous coronary intervention versus coronary artery bypass grafting for left main coronary artery disease: data from the prospective Multi-vessel Coronary Artery Disease (MULTICAD) Israeli Registry.

Left main coronary artery involvement in patients with multivessel coronary artery disease provides a poor prognosis. Although the main strategy for revascularization is by coronary artery bypass graf...

Medical and Biotech [MESH] Definitions

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.

Direct myocardial revascularization in which the internal mammary artery is anastomosed to the right coronary artery, circumflex artery, or anterior descending coronary artery. The internal mammary artery is the most frequent choice, especially for a single graft, for coronary artery bypass surgery.

A complication of INTERNAL MAMMARY-CORONARY ARTERY ANASTOMOSIS whereby an occlusion or stenosis of the proximal SUBCLAVIAN ARTERY causes a reversal of the blood flow away from the CORONARY CIRCULATION, through the grafted INTERNAL MAMMARY ARTERY (internal thoracic artery), and back to the distal subclavian distribution.

A congenital coronary vessel anomaly in which the left main CORONARY ARTERY originates from the PULMONARY ARTERY instead of from AORTA. The congenital heart defect typically results in coronary artery FISTULA; LEFT-SIDED HEART FAILURE and MITRAL VALVE INSUFFICIENCY during the first months of life.

Pathological processes of CORONARY ARTERIES that may derive from a congenital abnormality, atherosclerotic, or non-atherosclerotic cause.

More From BioPortfolio on "Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Stent
A stent is a small mesh tube that's used to treat narrow or weak arteries. Arteries are blood vessels that carry blood away from your heart to other parts of your body.  A stent is placed in an artery as part of a procedure called angioplasty. &...

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...

Cardiovascular disease (CVD)
Acute Coronary Syndromes (ACS) Blood Cardiovascular Dialysis Hypertension Stent Stroke Vascular Cardiovascular disease (CVD) includes all the diseases of the heart and circulation including coronary heart disease (angina...


Searches Linking to this Trial