Frequently Asked Questions

What is the purpose of this clinical research study?
The purpose of this study is to evaluate the safety and effectiveness of the SilverHawk® LS-C Device and the SpiderFX ™ Filter. These devices are used for removal of hardened plaque (calcium) from blocked arteries in your leg. You can speak with your doctor about the details of the procedure, and its risks and benefits before agreeing to participate in this study.

What is expected of me if I decide to join the study?
To be in the study, you must meet certain entry criteria, be willing to be available, agree to have all the required tests and be able to attend clinical visits in your area. Certain medications and medical exams are required before, during and after the research study procedures. You will be asked to return to the clinic for a follow-up assessment visit no more than one month after your procedure.

Who qualifies for this study?
The DEFINITIVE™ Calcium leg pain research study seeks patients needing clinical treatment to improve blood flow in the major blood vessel in their leg. If you pre-qualify based on the questions asked on this web questionnaire or telephone pre-screening, and when you make your first visit to the clinic or hospital, medically qualified personnel will complete the enrollment process to determine if you fully qualify for the study.

Where are the research sites?
Patients will be enrolled at up to 30 sites in the US. After you complete the pre-screening questionnaire on this web site or by calling our TeleMEDICINE Contact Center, we may be able to identify a nearby site for you.

How many people will be in this study?
About 102 people will take part in this study in the US.

When will I know if I qualify for this clinical study?
At the end of the screening questionnaire, you will know if you are pre-qualified for the research study. When you make your first clinic visit, medically qualified personnel will complete the enrollment process to determine if you fully qualify for the study.

How long will the study last?
There will be study tests prior to the procedure. After completion of the clinical procedure to remove the plaque from your artery, you will be assessed before you are discharged from the medical facility and have another assessment approximately one month later.

Should I still see my own doctor?
You are encouraged to discuss your participation in this research study with any doctor you are currently seeing. The research study doctor will normally be able to keep your current doctor informed of your progress and any test results.

Will I get paid to be in this study?
The sponsor is offering to reimburse qualified patients for their time and travel. Some study centers do not allow this, so if you do qualify for the study you should check with your study doctor to know if you can be compensated or not.

Who is sponsoring the study?
The study sponsor is ev3 Endovascular, Inc., who makes the SilverHawk® LS-C Device and the SpiderFX™ Filter. They will provide these medical devices to the doctor who performs the procedure.

Will my information be kept private?
Personal and medical information about you will be kept private. It will be kept in confidential and secured files. If you pre-qualify based on the screening questions on this web site or by telephone interview, the study site staff will answer further questions you may have about the privacy and security of your information..

Call today for a free pre-screening 1-866-860-6294