Minimally invasive treatment for peripheral artery disease
Endovascular Denervation for the Treatment of Patients With Peripheral Arterial Disease
NA · Zhongda Hospital · NCT05345431
This study tests a new minimally invasive treatment for people with peripheral artery disease to see if it can reduce pain and improve their quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Zhongda Hospital (other) |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT05345431 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of endovascular arterial denervation using a multi-electrode radiofrequency ablation system on patients with peripheral artery disease (PAD). The procedure aims to reduce sympathetic nerve excitability, which is believed to contribute to lower limb ischemia. By restoring normal sympathetic activity, the treatment seeks to alleviate symptoms such as pain and discomfort, ultimately improving patients' quality of life. Participants will be monitored for changes in their condition following the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with clinically confirmed PAD in Rutherford category II-VI.
Not a fit: Patients with recent thrombolytic therapy, vascular bypass surgery, or serious comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve symptoms and quality of life for patients suffering from peripheral artery disease.
How similar studies have performed: Previous studies have indicated that sympathetic overactivity plays a role in PAD, suggesting that this approach may be promising, though it may not have been extensively tested in this specific manner.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nanjing, Jiangsu
- Zhongda Hospital, Southeast University — Nanjing, Jiangsu, China (RECRUITING)
Study contacts
- Principal investigator: Gao-Jun Teng, MD — Zhongda Hospital
- Study coordinator: Gao-Jun Teng, MD
- Email: gjteng@seu.edu.cn
- Phone: +86 25 83272121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: PAD