Continuum Study

CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® VascUlar Stent SysteMs (CONTINUUM)
 
This study is enrolling participants by invitation only.
 
Sponsor:  
 C. R. Bard
Information provided by:  
 C. R. Bard
ClinicalTrials.gov Identifier:  
 NCT00908947

Purpose:
 
The objectives of this study are to collect post-market confirmatory evidence of the safety and effectiveness of the Bard® LifeStent® Vascular Stent System and LifeStent® XL Vascular Stent System (together the "LifeStent® Vascular Stent System").
The purpose of this study is to see how well study stent works at treating people with Peripheral Vascular Disease (PVD). This study will also test the safety of LifeStent Vascular Stent Systems and look at the effectiveness of the LifeStent Vascular Stent Systems. You have been invited to join this research study because your doctor is planning on treating a blockage in your Superficial Femoral Artery (SFA) (the artery which runs the length of your thigh) or popliteal artery (the artery running from lower thigh to knee) with a balloon and stent.
This is a national study with 25 locations across the country. The study will enroll a total of 170 people nationally. This location will enroll 10 people. 
This study requires that percutaneous transluminal angioplasty (PTA) or “ballooning” and stenting be performed to attempt to open your artery. A stent is an elastic metal tube used to keep an artery open. Your physician will explain how these two treatments are performed, and will ask you to sign a separate form giving your consent for the peripheral PTA and stenting procedure, using LifeStent Vascular Stent Systems. If you agree to take part in this study, you will have a Screening Visit to see if you qualify. If you qualify, and wish to continue, you will undergo your procedure and receive either a LifeStent Vascular Stent or a LifeStent XL Vascular Stent (collectively, the “LifeStent”). 
The LifeStent Vascular Stent is used to treat blockages up to 80 mm (or approximately 3 inches) in length, while the LifeStent XL Vascular Stent is used to treat blockages greater than 80 mm in length. Your physician will determine which stent is most appropriate to treat your blockage. 
If you do not qualify for the study, your doctor will treat the blockages with what he feels to be the most appropriate treatment for your condition.
Detailed Description:
The study is a prospective, multi-center, single-arm, non-randomized study enrolling up to 170 subjects with lifestyle-limiting claudication or ischemic rest pain attributable to lesion(s) (stenosed, occluded, restenosed, or re-occluded) in the infra-inguinal segment (SFA and/or proximal popliteal artery) that are amenable to treatment by PTA and stenting. All subjects enrolled in the study will receive PTA and stenting.
If you agree and are able to take part in this study you will undergo the following procedures:
Screening:
The following will be done at your initial screening visit:
  • You will have a urine pregnancy test if you are a woman of child-bearing potential (not post-menopausal or surgically sterile);
  • Your medical history and current medications will be documented;
  • You will have a comprehensive physical exam;
  • You will have blood pressure taken in your arms and legs (Ankle-Brachial Index (ABI)). An ABI measures the difference in blood pressure at your arm and your ankle, which assists in determining whether any blockages are present;
  • You will be asked to complete a questionnaire about your quality of life; and
  • You will have a catheterization procedure (angiogram). 
 
The catheterization involves placing a catheter (a thin plastic tube) in a blood vessel in your leg and injecting contrast media (dye) into your arteries. Before this procedure, local anesthetic (a numbing agent) will be placed in the skin and deeper tissues where the catheter will be inserted. An intravenous (IV) line will be placed in your arm in order to give you medicine.
If you qualify, you will undergo the study procedure which involves placement of the LifeStent®. Even if you are not enrolled in the study, you may receive PTA and a peripheral stent (including a LifeStent®), as this is a standard treatment for patients with blockages such as yours.
Your physician will determine whether you are a candidate for PTA and stenting upon review of your angiogram. 
PTA will involve the insertion of a catheter (a tube that enters the blood vessel) into one of your femoral arteries, which run along the folds of the groin. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in your artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough.
Once your physician determines that the artery has been opened enough, he may choose to place a LifeStent® within the area to keep the artery open. For LifeStent® placement, your physician will insert a catheter that has one of the two LifeStents loaded onto the end of it. The LifeStent® catheter (also called the stent delivery catheter) will be inserted into your femoral artery. Your physician will ensure that the LifeStent® is properly situated across the blockage in your artery, and then he/she will open (or expand) the LifeStent®. A balloon catheter will be inserted into you artery; the balloon will be placed within the stent and inflated in order to fully expand the stent. Once the LifeStent® is placed in your artery, you will be considered enrolled in the study, and will be monitored for 3 years following your procedure. 
 In the event that your physician cannot open (expand) the LifeStent® in your artery after insertion, you will be considered a “screen-failure.” This may occur as a result of a device malfunction or defect, but is not anticipated. You will still be monitored through your 30-day follow-up visit, but not thereafter. In this scenario, your physician will select the best treatment for your blockage.
You will have an angiography immediately after the procedure to look at your arteries.
Follow-up Study Visits:
30-days, 12 months, 24-months and 36-months after the index (study) procedure
You will have the following done:
  • You will be asked about changes in your health and medication;
  • You will be asked to complete a questionnaire about your quality of life;
  • You will have a comprehensive physical exam
  • You will have an ultrasound done on your treated leg;
  • You will have blood pressures taken in your arms and legs (Ankle-Brachial Index (ABI)). An ABI measures the difference in blood pressure at your arm and your ankle, which assists in determining whether any blockages are present;  and
  • You will have an x-ray of your treated limb at your 12-month and 24-month visit.
 
Your Role in the Study:
Your responsibilities as a study subject include the following:
  • Tell the truth about your medical history and current conditions;
  • Tell the study doctor about any problems you have during the study;
  • Tell the study doctor if you have been in a research study in the last 30 days or are in a research study now; and
  • Return for the follow-up visits and procedures at the times described above.
 
Time Commitment:
The total amount of time you will take part in this research study is 36 months.   There are 5 visits during the study and each visit should last approximately 2 hours.    Most of this time would be a part of the routine treatment of peripheral artery disease.
Benefits:
You will not receive any benefit from being in the study. However, the information gained from your taking part in this study may help others in the future.