FREQUENTLY ASKED QUESTIONS

What is the purpose of this clinical research study?
The purpose of this study is to collect information and find out if the use of the PROTÉGÉ® EverFlex™ Stent is more safe and effective than angioplasty alone when used in the major blood vessel in your thigh. The study will collect information on about 287 patients. Patients will be enrolled at up to 40 sites in the US and up to 6 sites in Europe. The PROTÉGÉ EverFlex Stent, as it is used in this study, is an investigational device. If you pre-qualify for this study, when you make your first visit to the clinic or hospital, the study staff will answer further questions you may have about the study purpose and objectives.

What is expected of me if I decide to join the study?
To be in the study, you must be willing to be available and agree to have all the required tests and activities done before and after the procedure. The study, including follow-up visits will last about three years. Follow-up visits are scheduled at pre-discharge, one month, six months, one year, two years and three years after your procedure.

Who qualifies for this study?
The DURABILITY II research study seeks patients needing clinical treatment to improve circulation in a major blood vessel in their thigh. If you pre-qualify for this study and live near a participating site, 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 40 sites in the US and up to 6 sites in Europe. The study site locations are listed on our Participating Locations page. This will continue to be updated if additional sites are added.

How many people will be in this study?
About 287 people will take part in this study in both the US and Europe.

When will I know if I qualify for this clinical study?
After answering the questions on this website or questions asked if you call our study call center, 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 place the stent, follow-up visits will continue for about three years. Follow-up visits are scheduled at one month, six months, one year, two years and three years after your procedure. A lot of doctors normally see their patients at these same time points.

Should I still see my own doctor?
You are encouraged to discuss your participation in this research study with any doctor you are be 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 hospitals 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 PROTÉGÉ EverFlex Stent System and they will provide stents 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 questions you answered on this web site or during our telephone interview, and are assigned a site, the study site staff will answer further questions you may have about the privacy and security of your information.