Orbit Study

Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions (ORBIT II)
 
This study is not currently recruiting participants.
 
Sponsor:
Cardiovascular Systems Inc
Information provided by:
Cardiovascular Systems Inc
ClinicalTrials.gov Identifier:
NCT01092416
 
What is Coronary Artery disease and how is it treated?
Coronary Artery Disease (CAD) is a blockage (stenosis) in one or more of your coronary arteries. CAD affects over 16 million people in the United States. CAD is most commonly treated with percutaneous coronary intervention (PCI), which is a procedure in which a thin hollow tube (catheter) is threaded through your blood vessels and delivers a device to your heart to treat the artery blockage. The most common PCI treatments are listed below:
 
Balloon Angioplasty-procedure in which a tiny balloon on a catheter tip is inserted in the artery blockage and inflated, pressing the plaque of the blockage against the artery wall and opening of the artery.
 
Stenting-procedure in which a wire mesh tube is placed within the blockage that acts like scaffolding to keep the artery open.

Artherectomy
-process of removing the plaque that is blocking the artery.

What is the Diamondback 360 Orbital Artherectomy System (OAS)?


 
                   
 
 
The OAS is a type of PCI treatment in this study. The OAS is a device designed to remove coronary blockages by sanding away hard plaque blocking the artery. Hard plaque makes it difficult to place a stent. The OAS is designed to make it safer and easier for your doctor to place a stent when you have hardened plaque causing blockages in your heart arteries.
If you choose to be part of this study and your doctor determines that you are eligible to participate, you will be treated with the OAS prior to receiving your stent.
 
What is this research study about?
The purpose of this study is to establish the safety and effectiveness of the OAS in facilitating stent placement. Even though the OAS is investigational in this study, it has been well tested in the laboratory.    It has also been used in an earlier study of 50 subjects with blocked coronary arteries. The OAS prepared arteries so that more successful balloon angioplasty could be done and a stent placed.  A different but very similar CSI device has already been cleared by the FDA to treat blockages in the leg arteries and has been used in more than 13,000 patients.
 
Why should I consider participation in this clinical research study?
There are no direct personal benefits to you for participating in the study besides having your blockage opened by the OAS prior to receiving your stent.  Your participation may help doctors understand how to select the best treatment options for other people with blockages like yours.  Your doctor will explain alternative treatments they believe will help your medical condition. These treatments include but are not limited to: other artherectomy devices, balloon angioplasty, stenting, and coronary artery bypass grafting.
 
What does participation in this study involve?     
Before you decide whether or not you wish to participate in the ORBIT II clinical research study, the details about this study will be explained completely to you. You will have time to ask questions , as well as to discuss the study with your doctor, family and loved ones.  If you decide that you are interested in participating in this study, you will receive a medical examination to determine if you are eligible. The questions asked and tests performed are standard practices and would likely be done if you were not part of the study screening.  If you agree to be part of this study, your involvement will include treatment of your CAD using the OAS prior to receiving your stent. You will also be required to see your doctor for a 30 day follow-up visit as well as an annual clinic visit or phone follow-up for up to 5 years post treatment or until the study is closed, whichever comes first.
 
Are there possible risks or discomforts?
Known risks in participating in this study are believed to be similar to those that occur with other standard methods of treatment for blockages in coronary arteries. There also may be risks that are not known at this time. You will be promptly informed if any new information develops which may cause you to change your mind about continuing in this study.