Cardiovascular Research Unit
Clinical Trials and Registries

CAROTID ARTERY DISEASE

CHOICE
Carotid Stenting for High Surgical Risk Patients; Evaluating Outcomes Through the Collection Of Clinical Evidence

Principal Investigator
Ray Matthews, M.D.

Study Coordinators
Karen Adams
Stephanie Mullin, R.N.

Study Summary
This study is about the use of a stent and an embolic protection system in treating a blockage, or stenosis, in the carotid artery.  A stent is an elastic like metal tube that is used to hold open a narrow part of a blood vessel.  An embolic protection system is a wire mesh basket designed to catch material (blood clots, fatty material) that could break off from the narrowed area of the blood vessel during the carotid stenting procedure. 

The sponsor of this study has 2 stent and embolic protection systems currently approved/cleared by the Food and Drug Administration (FDA) for use in patients who need to have stenting of a carotid artery.  The first system is the RX Acculink Carotid Stent System (RX Acculink) with the RX Accunet Embolic Protection System (RX Accunet) and the other is the Xact Rapid Exchange Carotid Stent System (the Xact stent) with the Emboshield BareWire Rapid Exchange Embolic Protection System (the Emboshield filter). 

The purpose of this study is to find out about a subjects medical experiences and conditions following treatment of carotid stenosis using one of these systems. 

Enrollment Status: OPEN

RESPECT
Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment

Principal Investigator
Ray Matthews, M.D.

Study Coordinators
Karen Adams
Stephanie Mullin, R.N.

Study Summary
A Patent Foramen Ovale (PFO) is an opening in the heart. Normally, the PFO closes at or shortly after birth. In some people, the PFO remains open and allows a blood clot to pass from the right side of the heart to the left side. Blood flowing from the left heart chamber can to to the brain, so a clot or piece of tissue crossing over through the opening could go to the brain and cause a stroke. The current treatment used to prevent another stroke or death is medicine to thin the blood to attempt to prevent further blood clot formation.

In this study, we hope to learn if an experimental device, called the AMPLATZER® PFO Occluder, is safe and effective in the treatment of PFO in people who have had a stroke. The purpose of this study is to compare the AMPLATZER PFO Occluder device to medicine in preventing another stroke or death related to a PFO and also to evaluate the safety of the device. The AMPLATZER ® PFO Occluder device is considered an experimental device because it has not been approved by the Food and Drug Administration (FDA).

Enrollment Status: OPEN

SAPPHIRE Worldwide Registry
Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy

Principal Investigator
Ray Matthews, M.D.

Study Coordinators
Karen Adams
Stephanie Mullin, R.N.

Study Summary
The purpose of this study is to establish a registry for people who will have a procedure called carotid stent supported angioplasty. Carotid stent supported angioplasty is an approved procedure being offered as an alternative to carotid artery surgery for narrowed carotid arteries.

Angioplasty (a balloon catheter technique) is an effective method of opening the blood vessels in the neck, heart and legs. A stent is a metallic device that behaves like a spring to keep the artery open. The devices that will be utilized are the Cordis PRECISE Nitinol Stent System and the Cordis ANGIOGUARD XP/RX Emboli Capture Guidewire (ECGW). The ECGW is a tiny filter basket at the end of the Guidewire in the shape of an umbrella intended to capture debris that might be released during the procedure and help reduce the chance of stroke. Both of these devices have been approved by the Food and Drug Administration (FDA). Other PRECISE stents that are approved for use by the FDA in the future may also be used.

This registry will collect information about the stent and distal protection and the people who are treated with it.

Enrollment Status: OPEN