Researchers in Northwestern Memorial Hospital's Center for Vascular Disease at the Bluhm Cardiovascular Institute are conducting clinical research trials to learn more about treating vascular disease.
Learn more about actively recruiting studies in this area below.
Principal Investigator(s): Mark K. Eskandari, MD
IRB Project Number: STU00071910- N-TACT
IRB Project Number: STU00071910
Description of Research Trial: 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.
IRB Project Number: STU00200290
Description of Research Trial: This study is recruiting participants that have carotid artery disease with no symptoms. This is called asymptomatic carotid artery disease. Carotid artery disease is caused by a thickened area (plaque) in the artery. The thickened area narrows the artery and may limit blood flow to the brain.
Participants in this study will receive either intensive medical management alone or intensive medical management and a surgical procedure to open the carotid artery. Intensive medical management includes treatments for lifestyle risk factors such as high blood pressure, high cholesterol, diabetes, and smoking cessation. The options for opening the carotid artery include carotid endarterectomy (CEA) or carotid artery stenting (CAS). CEA is surgical procedure. During CEA the thickened area (plaque) of the artery is removed through an incision (surgical cut) in the neck. CAS consists of placing a metal device called a stent in the narrowed part of the artery to hold it open.
The main purpose of the study is to find out if medical management alone results in different rates of death or stroke than medical management and a surgical procedure.
Overall, there will be about 2,480 people enrolled in this study across North America. We hope to enroll up to 20 participants at Northwestern.
Principal Investigator(s): Mark K. Eskandari, MD
IRB Project Number: STU00101601 BEST
IRB Project Number: STU000101601
Description of Research Trial: This study is recruiting participants diagnosed with peripheral artery disease (PAD) that has led to critical limb ischemia (CLI). In CLI, arteries that deliver blood to the leg and foot are narrowed or blocked by plaque buildup (atherosclerosis). CLI can cause pain in the foot or leg even when sitting or lying at rest; it also can cause foot and leg ulcerations, and can sometimes lead to gangrene and loss of the leg.
CLI is usually treated by operations or procedures that increase blood flow to the leg and foot, in order to relieve these symptoms, heal the ulcers, and preserve the limb. There are two different ways to increase the blood flow in CLI. One is with open surgery, which creates a bypass around the blockage. The other is with endovascular treatment (often called angioplasty), a minimally invasive procedure that opens the blocked arteries directly. Angioplasty is performed with balloons and other tools that clear plaque, and sometimes permanent implantation of small, mesh-like metal tubes called “stents”. Both types of treatment – open surgery and angioplasty - are considered reasonable and appropriate for patients with CLI. Half of the participants in this study will have open surgery and half will have endovascular treatment. The assignment of treatment is random, meaning purely by chance (50:50, just like a coin toss).
The purpose of the study is to learn about which therapy is more suitable for those patients who are candidates for both open surgery and endovascular treatment, and to provide information regarding cost effectiveness of the two different types of treatment.
We expect 2100 participants to enroll from approximately 120 different study centers across the United States, Canada, and possibly other countries. We hope to enroll up to 20 participants at Northwestern.
Principal Investigator(s): Andrew Hoel, MD
IRB Project Number: STU00094936 LUTONIX
IRB Project Number:STU00094936
Description of Research Trial: This study is recruiting patients who have a blocked blood vessel in their leg, which has previously been treated with a stent (hollow tube-like device that expands to hold open blockages in arteries) and has narrowed and may require retreatment. The purpose of this research study is to evaluate how well the LUTONIX® Drug Coated Balloon works compared to uncoated balloons for treatment of stented blood vessels in the leg that have had new blockage.
Balloon catheters are commonly used to expand narrowed blood vessels and treat stented areas that have new blockages. These devices are made up of a small balloon attached to the end of a thin tube. The sponsor of this study, Lutonix Inc., has developed a balloon catheter that is very similar in shape and size to other balloon catheters except that the balloon is coated with a drug called paclitaxel. Paclitaxel is a well-known drug that is currently used to treat various conditions, such as certain types of cancer. Paclitaxel is also used as a coating on stents for heart and leg vessels.
The LUTONIX® Drug Coated Balloon (study device) has been studied extensively in animals, and has been used in ongoing human clinical studies in Europe and the United States. The Study Device is considered investigational, which means it has not yet been approved by the U.S. FDA.
The purpose of this research study is to evaluate how well the LUTONIX® Drug Coated Balloon works compared to uncoated balloons for treatment of stented blood vessels in the leg that have had new blockage.
Information will be collected on the performance of the Study Device for up to five (5) years.
Patients will be asked to come to Northwestern before their procedure, for their procedure and return to the Study Doctor’s office at (1) month, six (6) months, one (1) year and two (2) years following the procedure for follow-up exams. In addition, research personnel will participants 36, 48 and 60 months (3, 4 and 5 years) after the procedure to ask about current health status.
IRB Project Number: STU00200722
Description of Research Trial: The purpose of this research study is to test whether the study drug is safe and see how well the study drug works compared to placebo (inactive substance that contains no study drug cells).
Two different doses of the study drug will be given to see if a certain dose is safer and/or works better than the other. In addition this study will try to see if the study drug may help with walking ability and quality of life of subjects who have claudication.
In this study, subjects will receive the study drug cells or a placebo by injection into the muscle of the leg that is more severely affected by claudication (‘affected leg’), at the beginning of the study and again 3 months later. At each of these two visits, there will be 30 injections into each subject’s leg muscles of 0.5 ml volume each (0.1 teaspoon) after subjects have rested for 30 minutes. Subjects may first be given a local anesthesia with EMLA cream (cream with anesthesia effect to reduce the local pain) on the injection area before each injection, so that these injections into the muscle of the leg will cause very little, if any discomfort.
This study will evaluate four different dosing groups: the first group (low dose) will receive 150 x 106 cells, the second group (high dose) will receive 300 x 106 cells, the third group will receive placebo and the fourth group will receive combination of high dose + placebo.
Subjects will be randomly assigned by chance (like the flip of a coin) to one of the four groups. This is a double-blind study, which means neither subjects nor the study doctor will know to which of these study dosing groups subjects have been assigned. In case of an emergency; however, the study doctor can get this information.
This research study plans to enroll approximately 150 study participants at approximately 60 sites, including approximately 10 people from this institution.
Principal Investigator(s): Heron Rodriguez, MD
IRB Project Number: STU00201636 LUCY
IRB Project Number: STU00201636
Description of Research Trial: An abdominal aortic aneurysm is a bulge in the aorta (the main artery leaving the heart) caused by a weakening in the artery wall. If left untreated, this bulge may continue to grow larger and ultimately rupture (break open), resulting in serious internal bleeding. The information collected from this study will be used to evaluate how well patients do when treated with the Ovation Prime Abdominal Stent Graft System (the study device) both immediately after surgery and at 1 month after surgery. If you decide to participate in this study, your medical condition will be carefully monitored.
Treatment of your AAA with the study device involves the placement of specially designed grafts (fabric tubes) in your aorta. The main graft looks like a pair of pants with very short legs. The top of the pants will be placed in your aorta. Then, two or more smaller grafts are used to extend from the main graft into your iliac arteries (the main arteries supplying blood to your abdomen and legs) to form the legs of the pair of pants. Each graft is enclosed in a small catheter (a long, flexible tube) that is inserted into your aorta through the femoral artery in your groin (top of your leg). The grafts are then placed in the correct position in your aorta by releasing them from the catheters. Once the grafts are attached inside your aorta, they will reinforce the area of your aorta that is weakened and bulging from your aneurysm. This procedure is called an endovascular aneurysm repair because the grafts are delivered through your blood vessels.
This research study plans to enroll approximately 225 study participants, including approximately 5 people from this institution.
Principal Investigator(s): Karen Ho, MD
IRB Project Number: STU00201946 STOP-PAD
IRB Project Number: STU201946
Description of Research Trial: The first reason for conducting this study is to measure the effectiveness of giving the study drug to subjects with advanced PAD and a non-healing wound that are already planning to have a revascularization procedure. Two different doses of the study drug will be compared to placebo (an injection that looks like the study drug but does not have any active ingredient in it). The study drug or placebo will be given by direct injection into your affected lower leg and foot.
The second reason for conducting this study is to investigate the safety and tolerability of the study drug given by direct intramuscular injection to subjects with advanced PAD and non-healing wounds
This research study plans to enroll approximately 120 study participants nationally, including approximately 10 people from this institution.
Research Trial Contact Information:
For more information, participants and clinicians may contact the research team at (312) 926-4000 or firstname.lastname@example.org.
Principal Investigator(s): Chris Malaisrie, MD
IRB Project Number: STU00202843 Thoraflex
The purpose of this research study is to determine if a new investigational device, Thoraflex Hybrid, is safe and effective for the surgical treatment of damage or disease of the aorta. The aorta is the main artery that takes blood away from the heart and runs through the chest and abdomen. The damage or disease may be due to either a bulge or ballooning in the wall of the aorta (called an aneurysm) or a tear in the wall of the aorta (called a dissection). The Thoraflex Hybrid device is used to treat both aneurysm and dissection of the aorta in the chest.
Surgery for aneurysm/dissection involves replacing the weakened section of the vessel with an artificial tube, called a graft. This may be done by either, cutting out the weakened area and replacing with a graft, or by placing a graft inside the weakened blood vessel to act as a lining. The study device combines both these types of procedure in a single device. The Thoraflex Hybrid device has been licensed in Europe since 2012, but is not yet approved by the U.S. Food and Drug Administration (FDA). As the device is not yet approved by the FDA it is classed as an “Investigational” Device.
This study will involve about 65-80 people at about 14 different centers in the United States. We hope to enroll up to 10 patients at Northwestern.
Find information on participating in the research done through the BCVI CTU via our Frequently Asked Questions page.