PADEDPADNCT05345431
Endovascular Denervation for the Treatment of Patients With Peripheral Arterial Disease
A study testing endovascular denervation and PTA in people with PAD, run by Zhongda Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- PAD
- What is being tested?
- endovascular denervation and PTA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2022to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- eligible subjects aged 18-75 years,
- clinically confirmed PAD patients in Rutherford category II-VI.
Who cannot join
- 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 the last 1 month or ischemic stroke or transient ischemic attack within 2 weeks,
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- pacemaker implants,
- patients who are pregnant, breast-feeding or planning pregnancy,
- expected survival < 24 months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital, Southeast University
Nanjing, Jiangsu
About this study
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.
Read the detailed description
Peripheral arterial disease(PAD) show insufficient blood supply of diseased limbs, which causes intermittent claudication of lower limbs, reduced skin temperature, pain, and chronic progressive disease that still produces ulcer or necrosis. Some clinical studies have shown Sympathetic overactivity in the lower arterial ischemic disease. The multi-electrode radiofrequency ablation system can significantly reduce the excitability of sympathetic nerve, restore the normal response of sympathetic nerve, relieve the pain and discomfort of patients, effectively improve the symptoms of lower limb ischemia, and improve the quality of life of patients.
- Conditions
- PAD
- Being tested
- endovascular denervation, PTA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endovascular denervationDevice
Treating with EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation
PTADevice
Treating with balloon dilation or stent implantation
| Study group | Role | What they receive |
|---|---|---|
| The control group | Other | Treating with balloon dilation or stent implantation only, Receives: Device: PTA |
| The EDN group | Experimental | Treating with EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation. Receives: Device: endovascular denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemia relief
Changes of the ankle brachial index(ABI)
Measured: from baseline to 6 months after procedure
Secondary outcomes (3)
Ischemia relief
Changes of the ankle brachial index(ABI)
Measured: from baseline to 3 months after procedure
clinical benefit
Changes of the Rutherford category(Rutherford category includes a total of 0-6 grades, the lower the grade, the better the results)
Measured: from baseline to 3, 6 months after procedure
pain relief
Changes of the numeric rating scale ( NRS) scores(NRS scores includes a total of 0-10 grades, the lower the grade, the better the results)
Measured: from baseline to 3 ,6 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start25 Apr 2022 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PADStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao-jun Teng, Zhongda Hospital
- Investigators
- Gao-Jun Teng, MD, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345431
- Sponsor's protocol ID
- EDN-PAD
- Acronym
- EDPAD
- Status last verified
- Apr 2022
- First submitted
- 12 Apr 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Denervation for the Treatment of Patients With Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT05345431
- Acronym / sponsor ID
- EDPAD / EDN-PAD
- Conditions
- PAD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 25 Apr 2022 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Peripheral arterial disease(PAD) show insufficient blood supply of diseased limbs, which causes intermittent claudication of lower limbs, reduced skin temperature, pain, and chronic progressive disease that still produces ulcer or necrosis. Some clinical studies have shown Sympathetic overactivity in the lower arterial ischemic disease. The multi-electrode radiofrequency ablation system can significantly reduce the excitability of sympathetic nerve, restore the normal response of sympathetic nerve, relieve the pain and discomfort of patients, effectively improve the symptoms of lower limb ischemia, and improve the quality of life of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The control group | Other | Device: PTATreating with balloon dilation or stent implantation only, |
| The EDN group | Experimental | Device: endovascular denervationTreating with EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- eligible subjects aged 18-75 years,
- clinically confirmed PAD patients in Rutherford category II-VI.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endovascular denervationTreating with EDN at the site of the iliac artery distal to the superficial femoral artery proximal before balloon dilation or stent implantation | Device | The EDN group |
| PTATreating with balloon dilation or stent implantation | Device | The control group |
Primary outcome
Ischemia relief
Time frame: from baseline to 6 months after procedure
Changes of the ankle brachial index(ABI)
3 secondary outcomes
Ischemia relief
Time frame: from baseline to 3 months after procedure
clinical benefit
Time frame: from baseline to 3, 6 months after procedure
pain relief
Time frame: from baseline to 3 ,6 months after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gao-Jun Teng, MD principal investigator
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endovascular denervation and PTA in people with PAD, run by Zhongda Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gao-Jun Teng, MD (+86 25 83272121, gjteng@seu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ischemia relief (time frame: from baseline to 6 months after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.