Deep Vein Thrombosis (DVT) occurs when a blood clot or thrombus forms in one of the deep veins in your body, limiting blood flow. It usually occurs in your leg or pelvis. A serious complication of DVT is when a leg blood clot breaks loose and travels in the blood to another area of the body. This is called Venous Thromboembolism. If the clot isn’t dissolved within a few weeks it becomes a Chronic Deep Vein Thrombosis (Chronic DVT). The old blood clot can permanently damage both the vein and the valves that control blood flow in your legs creating a condition called Post-Thrombotic Syndrome (PTS). An estimated 50 percent of patients with Chronic DVT may develop PTS.1,2 PTS can cause long-term disability and impact your quality of life. Some of the symptoms of PTS include:
- Skin redness and discoloration
- Cramps, itching
- Tingling or numbness
- Swelling and heaviness
- Chronic pain
- Skin ulcerations
For a list of physicians treating chronic DVT with EKOS™ therapy, click here.
ACCESS PTS Clinical Trial
ACCESS PTS was a clinical research study conducted in the United States for the treatment of Chronic DVT with Post-Thrombotic Syndrome (PTS). It includes DVT treatment using the EkoSonic™ Endovascular System (EKOS™ therapy or EKOS™) – an FDA-cleared device that delivers clot-dissolving drugs (thrombolytic drugs) to the thrombus. The purpose of this research study was to evaluate whether your PTS symptoms (blood clot in leg symptoms) improve after the study treatment, how much leg blood clot can be dissolved using EKOS™ with a thrombolytic drug (clot-dissolving drug), and how much blood flow can be restored in your leg. There is research data that shows EKOS™ therapy is effective when treating acute blood clots (clots that have recently occurred). With this study, we conducted research to evaluate how well this system works with clots that are at least 6 months old and have not been responsive to traditional treatments such as elastic compression stockings and blood thinning drugs (anticoagulants).
ACCESS PTS Clinical Trial Results3
EKOS™ therapy with balloon dilatation has been shown to be effective and safe in improving the signs and symptoms of PTS.
- Clinically significant improvements in the signs and symptoms of PTS at a low tPA dose: 18.5mg ±7.5 and an average of 23hrs of ultrasound therapy
- Met primary endpoint, reduction in Villalta Score ≥4 at 30 days
- 35.5% improvement in the signs and symptoms of PTS at 30 days (as measured by Villalta Score*)
- Mean VEINES-QOL score improved by 21% at 30 days**
- One major bleed occurred within 72hrs and one PE occured within 30 days of the Acoustic Pulse Thrombolysis™ procedure
To view the full study summary, click here.
*Villalta Score measures the signs and symptoms of PTS
**N=60 for VEINES-QOL measurement