Patients with thoracic aortic dissection may qualify for new, less invasive treatment. A new treatment, approved for investigational use by the Food and Drug Administration (FDA), is available at [insert name of institution] for patients who have been diagnosed with a thoracic aortic dissection (a tearing of the body’s main blood vessel). If you meet study requirements, you could participate in the STABLE™ Clinical Trial (Study for Thoracic Aortic Type B Dissection using Endoluminal Repair), which could eliminate the need for highly invasive surgery.
To be considered for participation in the STABLE™ Clinical Trial, you must meet the following general study criteria: • 18 or older • Diagnosed with a descending thoracic aortic dissection warranting surgical intervention • Assessment performed by a study physician in compliance with the study protocol For more information about this trial, call [insert phone number].
Does your patient have a Type B thoracic aortic dissection? [Name of institution] is recruiting patients for endovascular treatment www.thoracicaorticdissection.com
[Insert name of institution] is pleased to announce that it is part of a global multicenter clinical trial involving a combination of endovascular medical devices for the treatment of thoracic aortic dissections. The STABLE™ Clinical Trial (Study for Thoracic Aorta Type B Dissection using Endoluminal Repair) involves the Zenith TX2® TAA Endovascular Graft Proximal Component and the Zenith® Dissection™ Endovascular Stent, both provided by COOK Medical, to seal off the entry tear, hold the layers of the aorta together and keep open blood flow to the arteries that branch from it. This study is currently in the recruitment phase for patients who meet the following general study inclusion criteria:
• Diagnosed with a Type B descending thoracic aortic dissection warranting surgical intervention
• Age 18 or older
• Assessment performed by a study physician in compliance with the study protocol
If you have a patient with a thoracic dissection who may be a candidate for this trial and you would like additional information, please call: [Insert contact information]
Heart attack or thoracic aortic dissection? The symptoms can be similar. Before you diagnose a heart attack, determine if your patient is suffering from a thoracic aortic dissection. Symptoms include: •
Sharp or tearing pain in the chest or back between the shoulder blades that radiates to the shoulder, neck, arm, jaw, abdomen or hips
How do I receive information about endovascular treatment?
What you need to know about thoracic aortic dissection.
Ask your doctor if you are a candidate for treatment with a combination of a graft and stent as part of the STABLEâ„˘ Clinical Trial.
CAUTION - Investigational device. Limited by Federal (or United States) law to investigational use.
750 Daniels Way, P.O. Box 489, Bloomington, IN 47402-0489 U.S.A. Phone: 812 339-2235, Toll Free: 800 457-4500, Toll Free FAX: 800 554-8335
WHAT IS THORACIC AORTIC DISSECTION?
The aorta is the main blood vessel that carries blood from the heart to the rest of the body and extends from the chest to the lower abdomen. Sometimes, with aging, hypertension, or other changes, a section of the aorta may weaken and tear. Tearing of the inner layers of the vessel walls allows blood to flow into the middle layer of the aorta, separating the inner and outer layers. This tearing is called a dissection. When the dissection occurs in the part of the aorta that runs through the chest, it’s called a thoracic aortic dissection.
patients as a very sharp or tearing pain in the chest or in the back between the shoulder blades. The pain may radiate to the shoulder, neck, arm, jaw, abdomen or hips, and the location may change as the aortic dissection progresses. In addition to this sharp pain, patients often suffer from:
• • • • •
Dizziness Profuse sweating Rapid pulse Difficulty walking Confusion
WHAT SHOULD I DO IF I SUFFER FROM THESE
NEW TREATMENT OPTIONS
Acute aortic dissection is life threatening, so it’s important to get medical attention immediately. TREATING THORACIC AORTIC DISSECTION
The goal of all thoracic aortic dissection treatment is to prevent the aorta from bursting or blocking the blood supply to other areas of the body. WHAT ARE ITS CAUSES?
There is no one cause of thoracic aortic dissection. However, it’s believed that patients with atherosclerosis (hardening of the arteries) or high blood pressure are at increased risk of tearing of the aortic wall. Other risk factors include: • Family history • Smoking • Heart disease • Blunt trauma to the chest Aortic dissection is rare. It can affect anyone, but is most common in men ages 40 to 70. WHAT ARE THE SYMPTOMS?
Symptoms of acute thoracic aortic dissection are often sudden and include severe pain, often described by
Two current treatment options: • Surgical repair • Medical management
Endovascular – which means inside of within a blood vessel - repair is being studied as an alternative to open surgical repair. Instead of making a large incision in the chest, the doctor makes a small incision near each hip to access the blood vessels in the leg through which a medical device is inserted and positioned inside the aorta. To treat dissections, doctors are studying the use of both a graft (a fabric tube) and a metal stent. The graft is sized to cover the tear in the aorta and restore blood flow to its normal path. Below the endovascular
Surgical repair involves opening the chest cavity, clamping the aorta and sewing a surgical graft in place to replace the damaged section of the aorta. This is most often the option for patients with acute (recently occurring) thoracic aortic dissection in the ascending aorta. Medical management involves the use of prescription drugs to aggressively lower blood pressure and heart rate while the aorta heals. This traditionally has been the option for patients whose thoracic aortic dissection is diagnosed early in development and is located in the descending aorta just below the subclavian artery (the artery to the left arm).
stent graft, a bare metal stent (or stents) is positioned to reinforce and hold the layers of the aorta together while keeping open blood flow to the arteries that branch off of it. It is inserted while collapsed, and once in position, it expands out to the vessel wall for support. The two pieces work in combination to seal the tear, prevent blood leakage and reinforce the wall of the aorta. Your doctor is currently involved in the STABLE™ Clinical Trial (Study for Thoracic Aortic Type B Dissection using Endoluminal Repair) which uses the Zenith TX2® TAA Endovascular Graft Proximal Component and the Zenith® Dissection™ Endovascular Stent.
Published on Feb 13, 2010
Direct mail, posters, brochures and a website were produced to promote the clinical Cook Medical STABLE clinical trial.