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MedStar Health was the first in the nation to enroll a patient in this multicenter trial of a new device to treat in-stent thrombosis.
In rare cases, a stent placed in a vein can develop a blood clot, which may obstruct the vein that the device was originally meant to treat. Currently, there are few effective treatments available, but new research at MedStar Health could lead to a safe and effective option.
Blood clot formation in deep veins can be just the beginning of a complicated health journey. About 20%-50% of the 900,000 people who have deep vein thrombosis in the U.S. each year will develop a chronic, painful condition called post-thrombotic syndrome (PTS).
An expandable metal tube called a stent can help keep veins open in many patients with PTS. Yet about 25% of those stents fail within three years, causing the vein to close off. This complication, called in-stent thrombosis (IST), causes challenging symptoms, including fatigue, swelling, and pain.
There hasn’t been a good treatment for venous ITS—until now.
MedStar Health was the first research center in the U.S. to enroll a patient in a single-arm, multicenter prospective study to evaluate the safety and effectiveness of The RevCore™ Thrombectomy Catheter, a device designed to meet this unmet need for patients with venous thrombosis.
Research at the forefront of innovation.
To explore the safety and effectiveness of the RevCore device, 30 study sites across the country will enroll 100 adults with IST.
All enrolled patients will receive treatment with the device, and we will closely monitor them to study whether the treatment successfully reopens the vein. We’ll follow patients for a year to examine how their quality of life improves and whether they need to return to the hospital.
MedStar Health was the first to implant this device in a patient. We’re proud to be at the forefront of this exciting research because we know these advances make a difference for our patients and communities.
An effective way to treat IST.
Existing treatments for IST have produced subpar outcomes. Techniques involving suction, using a balloon to reopen the vein, and methods to dissolve clots have had limited success.
These procedures can be helpful when a clot first forms, but they are less effective for chronic clots. This is due in part to the nature of these clots. After about two weeks, clots can become tough and fibrous with scarring and collagen deposits. Chronic clots can’t be suctioned and won’t dissolve. Balloons offer limited results, producing small channels in the vein that close again in time.
The device is highly adjustable for stubborn IST clots which has that scar like morphology. Vascular surgeons thread the device through the vein until it reaches the clot. There, they can precisely adjust the diameter of the core and spin (rev) the device, so it removes the entire clot from inside the stent and reopens the vein.
Our patients have been very pleased with the outcomes in anecdotal early results.
Providing hope for patients with IST.
When clots form deep in leg veins, there can be serious consequences for patients’ quality of life. For years, there were no practical solutions to help patients with IST. Now, we can offer them hope.
We’re excited to see the RevCore device make a real difference for our patients, and we’re looking forward to helping even more patients get access to this innovative treatment. Here in Washington, DC, treatments like these help underserved patient populations not just live longer but live better with procedures that can decrease the severity of their symptoms, help heal wounds, and improve their quality of life.
