Endovascular Denervation for the Treatment of Patients With Peripheral Arterial Disease

Launched by ZHONGDA HOSPITAL · Apr 20, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with Peripheral Arterial Disease (PAD), a condition that can cause pain and discomfort in the legs due to poor blood flow. The treatment being tested is called Endovascular Denervation (ED), which is a minimally invasive procedure that uses radiofrequency energy to help improve blood flow in the lower limbs. The goal of this study is to see how effective this technique is in relieving symptoms associated with PAD.

To participate in this trial, individuals need to be between the ages of 18 and 75 and have been diagnosed with PAD, specifically in certain stages of the disease. However, some people may not qualify, especially those who have had recent surgeries or specific medical conditions that could complicate the treatment. If eligible, participants will receive the ED procedure and will be monitored to check how well it helps with their symptoms. This trial is currently looking for volunteers, and if you or someone you know fits the criteria, it could be an opportunity to access a new treatment option.

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Eligibility criteria

• Inclusion Criteria:
• • 1. eligible subjects aged 18-75 years,
• • 2. clinically confirmed PAD patients in Rutherford category II-VI.
• Exclusion Criteria:
• • 1. thrombolytic therapy performed within 30 days,
• • 2. patients who had undergone vascular bypass surgery before this study,
• • 3. allergy or contraindication of antiplatelet drugs, anticoagulants, thrombolytic drugs and contrast agents,
• • 4. patients with obvious bleeding tendency, coagulation dysfunction, hypercoagulability and blood system diseases,
• • 5. serious liver and kidney diseases,
• • 6. history of hemorrhagic stroke within the last 1 month or ischemic stroke or transient ischemic attack within 2 weeks,
• • 7. pacemaker implants,
• • 8. patients who are pregnant, breast-feeding or planning pregnancy,
• • 9. expected survival \< 24 months.