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Endovascular radiofrequency ablation of sympathetic nerves on the superficial femoral artery to treat thromboangiitis obliterans: a multicenter, randomized, three-arm, open-label clinical trial

Efficacy of endovascular radiofrequency ablation for thromboangiitis obliterans

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016237
Enrollment
Unknown
Registered
2018-05-21
Start date
2018-05-21
Completion date
Unknown
Last updated
2018-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thromboangiitis obliterans

Interventions

Bypass surgery group:patients underwent vascular bypass surgery.
Balloon expansion group:balloon inflation
Endovascular radiofrequency ablation group:endovascular radiofrequency ablation

Sponsors

Shanghai pudong hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Between the ages of 18-50 years; 2. Ultrasound, CTA, MRA, or angiography confirmed the diagnosis of superficial femoral artery stenosis and sub-articular stenosis with a stenosis of >50%; 3. Rutherford grade = 4 points; 4. According to the TASC II criteria, there is evidence of lower limb arterial ischemia: the blood pressure of the affected side of the sacroiliac joint is <50-70mmHg, the pressure at the toe end is <30-50mmHg or the partial transcutaneous oxygen pressure (TcPO2) is <30-50mmHg; 5. Signing of informed consent.

Exclusion criteria

Exclusion criteria: 1. CTA examination found no distal outflow tract, or judged by physicians as not suitable for interventional therapy; 2. Amputation has been considered in the near future; 3. accompanied by life-threatening complications or severe infections; 4. With tumors; 5. Intervention, surgery or cell transplantation therapy within the past 3 months; 6. Pregnancy or lactation; 7. Cardiovascular and cerebrovascular events of myocardial infarction and stroke occurred in the past 3 months.

Design outcomes

Primary

MeasureTime frame
pain score;

Secondary

MeasureTime frame
pain score;Surgery success rate;Vascular patency rate;Clinical benefit rate;ABI;The preserve rate of limbs;Amputation or truncation rate;the period of no rest pain;skin temperature;

Countries

China

Contacts

Public ContactJingdong Tang

Shanghai Pudong Hospital

drtangjingdong@vip.126.com+86 13818226354

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026