Research Trials in the Center for Vascular Disease

GORE® TIGRIS® Vascular Stent Clinical Study

The GORE^® TIGRIS^® Vascular Stent Clinical Study is recruiting participants who have been diagnosed with obstructive peripheral artery disease ("PAD"). The standard treatment for this condition is the insertion of a permanently implanted, self-expanding, vascular stent ("stent") to hold the blockage in the leg open. 

The purpose of this Study is to determine the safety and effectiveness of the GORE^®  TIGRIS^® Vascular Stent (the "Study Device") when used to treat patients with obstructive peripheral artery disease (PAD).

The Study Device is a self-expanding vascular stent. Vascular stents are hollow tube-like devices that expand to hold open blockages in arteries. The Study Device is made by forming a wire into a zigzag pattern, and then winding it into a hollow tube shape. The wire is covered with a flexible polymer film (a plastic-like material), with bridges of the polymer connecting adjacent rows of wire in the tube to maintain their even spacing. A small amount of heparin, a drug used to prevent blood clots, is permanently attached to the surfaces of the tube.  

The Study Device is considered investigational, which means it has not yet been approved by the U.S. FDA.

Your participation in this study would last three (3) years.

A randomised, double-blind, parallel group, multicentre phase IIIb study to compare ticagrelor with clopidogrel treatment on the risk of cardiovascular death, myocardial infarction and ischaemic stroke in patients with established Peripheral Artery Disease (EUCLID – Examining Use of  tiCagreLor In paD)

The EUCLID trial is recruiting patients with symptoms of peripheral arterial disease (PAD) including leg discomfort associated with physical limitations such as claudication (painful, aching, cramping, uncomfortable or tired feeling in the legs that occurs during walking and is relieved in rest), pain during rest, or ulcers. Patients with PAD are at a significant risk to have heart problems and stroke. This study is being carried out to see if the study drug given twice daily is effective in preventing the occurrence of heart attack, stroke and/or death due to heart problems in patients who have peripheral arterial disease and if so, how it compares with  another study drug given once daily. 

It is not known whether the study drug(s) being investigated in this research trial is safe or effective.

Because of the way the study is designed, the length of your participation may vary from approximately 18 months up to 3 years.  If you agree to participate, you will be asked to come to the vascular clinic at Northwestern at least 6 times, up to 9 times.  You will also have from 2 to 5 telephone call “visits” in between your clinic visits. 

Juventas

The Junventas trial is a Phase IIa study  recruiting patients diagnosed with critical limb ischemia (severe obstruction of the blood vessels which seriously decreases blood flow to the hands, feet and legs) from having advanced peripheral vascular disease (disease of the blood vessels outside the heart). The main purpose of this study is to investigate the safety, possible harms, and side effects of infusing an experimental gene plasmid agent called JVS-100 (the “Study Drug”) into a patients limbs.

The Study Drug is a liquid that contains pieces of genetic material (DNA) that, when injected directly into the muscle in a subjects leg, may help the body’s cells make a protein called Stromal Cell-derived Factor 1 (SDF-1).  The Study Drug has not been approved for use by the US Food and Drug Administration (FDA), its use in this study is investigational.

Participation in this study will be about 12 months and will include 7 total study visits. There will be about 48 subjects who will take part in this study at up to 10 centers around the world. 

Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (N-TA3CT)

This study is recruiting subjects that have been diagnosed with an abdominal aortic aneurysm.  An abdominal aortic aneurysm is when the large blood vessel (aorta) that supplies blood to the abdomen, pelvis, and legs becomes abnormally large or bulges outward. Small bulges can stay the same size for a time; most grow slowly; some grow quickly. No one knows exactly why there are these differences. When a small bulge is present, the usual course is to check its size every 6 months to see if it enlarges to a size that should be fixed. If the bulge grows to this larger size, there is a danger it will burst, which would be a threat to your life. Your doctors would recommend fixing the bulge if it becomes large enough to pose a risk to you.

The purpose of this study is to determine the effects of a medicine called doxycycline (“study medicine”) compared to placebo (an inactive pill) on the growth of this blood vessel bulge. If the study medicine slows the growth of the bulge in blood vessels, in future years it could be used to prevent the need for surgery or repair to the blood vessel.  It is thought that doxycycline may block an enzyme that acts to take apart proteins in the bulge wall.

The time it might take for the bulge to reach this large size could be short (6 months) or long (years). Because bulge growth varies, it can be hard to tell if a new medicine really works. To find out if the study medicine can slow the growth, we have to test it along with a matching placebo (inactive) capsule. Because these bulges typically grow at a slow rate, we will need to follow the growth for 2-3 years to see if there is a difference.

The study medicine, doxycycline, is approved by the Food and Drug Administration (FDA) for treatment of certain bacterial infections (antibiotic). However, use of the doxycycline in this study is experimental since the research study is trying to determine if it can slow or stop the growth of abdominal aortic aneurysms.

Subjects will be asked to return for follow-up visits every three (3) months for a minimum of 2 years or a maximum of 3.5 years.

INSPIRATION: A Multi-Center, Open Label, Prospective, Non-Randomized Study of the ™ Stent Graft System in Subjects with Abdominal Aortic Aneurysms

The INSPIRATION study is recruiting participants who have been diagnosed with abdominal aortic aneurysms (“AAA”).  An AAA is a weakened/enlarged part of the aorta, which is the largest blood vessel in the body.   Because the vessel wall of the aorta is weak, it has a high risk of rupturing in the abdomen, causing internal bleeding, often without warning.

One way to prevent rupture of the AAA is open surgical repair of the aneurysm, which has been done for many years. Surgical repair of the AAA requires general anaesthesia, a 20-30 cm incision and major surgery of your abdomen.   Inserting a long, thin, tube-like structure into the body through the blood vessels (“Catheter-based endovascular technology”) is another option to treat AAA.  This method has the potential to reduce surgery-related risks (such as bleeding) and shorten hospital stays (allowing you to leave the hospital earlier) compared to open surgical repair. 

The purpose of this clinical research study is to evaluate the safety of the INCRAFT™ Stent Graft System (“study device”) and it’s effectiveness in the treatment of subjects with abdominal aortic aneurysms requiring repair.  The Study Device is considered investigational, which means it has not yet been approved by the U.S. FDA, however it has been used in a small number of subjects in Europe to evaluate the safety of the device in the short term.

SAPPHIRE WW - Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomy

This study is enrolling patients who will be undergoing carotid stent supported angioplasty using PRECISE® Stent System and ANGIOGUARD™ XP/RX.  This procedure treats a narrowed artery in the neck called the carotid artery, which supplies blood to the brain.  This condition has either produced symptoms that include small strokes, or if without symptoms, could cause a future stroke.

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 heart and legs.  A stent is a mettalic device that behaves like a spring to keep the artery open.  The devices that will be used are the Cordis PRECISE® Nitinol Stent System and the Cordis ANGIOGUARD™ XP/RX Emboli Capture Guidewire (ECGW).  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 study will collect information about the devices in 15,000 patients in North America.  Approximately 70 patients will participate at Northwestern University.