N/A
N=38
Endovascular Denervation Improves Limb Ischemia in Patients With Peripheral Artery Disease
PAD
Bottom Line
View on ClinicalTrials.gov: NCT04060797 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Change of Ankle Brachial Index (ABI) at 6-month Post-procedure. — 0.24; 0.44 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- endovascular denervation (Device); PTA (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zhongda Hospital
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Ankle Brachial Index (ABI) at 6-month Post-procedure. |
0.24; 0.44 | — |
| SECONDARY Change of Ankle Brachial Index (ABI) at 3-month Post-procedure. |
0.28; 0.48 | — |
| SECONDARY Change of Ankle Brachial Index (ABI) at 1-week Post-procedure. |
0.21; 0.28 | — |
| SECONDARY Change of Transcutaneous Oxygen Pressure (TcPO2) |
5.16; 7.12 | — |
| SECONDARY Change of Transcutaneous Oxygen Pressure (TcPO2) |
5.16; 7.12 | — |
| SECONDARY Change of Transcutaneous Oxygen Pressure (TcPO2) |
5.16; 7.12 | — |
| SECONDARY Rutherford Category |
8; 11 | — |
| SECONDARY Rutherford Category |
8; 11 | — |
| SECONDARY Rutherford Category |
8; 11 | — |
| SECONDARY NRS Score |
1; 0 | — |
| SECONDARY NRS Score |
1; 0 | — |
| SECONDARY NRS Score |
1; 0 | — |
| SECONDARY Number of Participants With MACE (Major Adverse Cardiovascular Events) and MALE (Major Adverse Limb Events) |
0; 0 | — |
Summary
Sympathetic overactivity partly promotes the development of peripheral artery disease which mainly leads to ischemia of the lower limbs. Endovascular arterial denervation (ED) is a minimally invasive technique which could deliver Radiofrequency energy by a multi-electrode catheter to the Lower limb artery to restore Sympathetic activity. The purpose of this study is to evaluate the effects of multi-electrode radiofrequency ablation system on lower limb ischemia with PAD.
Eligibility Criteria
Inclusion Criteria
- eligible subjects aged 18-75 years,
- clinically confirmed PAD in the lower extremities,
- Rutherford category II-VI.
Exclusion Criteria
- thrombolytic therapy performed within 30 days,
- patients who had undergone vascular bypass surgery before this study,
- allergy or contraindication of antiplatelet drugs, anticoagulants, thrombolytic drugs and contrast agents,
- patients with obvious bleeding tendency, coagulation dysfunction, hypercoagulability and blood system diseases,
- serious liver and kidney diseases,
- history of hemorrhagic stroke within last month or ischemic stroke or transient ischemic attack within 2 weeks,
- pacemaker implants,
- patients who are pregnant, breast-feeding or planning pregnancy,
- expected survival < 24 months.
Data sourced from ClinicalTrials.gov (NCT04060797). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.