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The Safety and efficacy study of rotatIng mechanical aspiratioN combined with Angioplasty in the tReatment of Burger's dIsease: a prOspective, multicenter, single-arm study

The Safety and efficacy study of rotatIng mechanical aspiratioN combined with Angioplasty in the tReatment of Burger's dIsease: a prOspective, multicenter, single-arm study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061729
Enrollment
Unknown
Registered
2022-07-01
Start date
2022-08-01
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Burger‘s disease

Interventions

treatment group:rotatIng mechanical aspiratioN combined with Angioplasty

Sponsors

Pudong hospital of Fudan university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients with symptomatic vasculitis; 2. Occlusion scope: 1/3 below the knee - common femoral artery; 3. Age 18-60; 4. At least one outflow tract below the knee.

Exclusion criteria

Exclusion criteria: 1. History of thrombosis, atrial fibrillation, hypertension, diabetes, hyperlipidemia, etc. caused by atherosclerosis; 2. History of bleeding diseases within 6 months; 3. History of acute cardiovascular and cerebrovascular diseases within 3 months; 4. Caused by vascular malformation; 5. The extent of the lesion involves the lower 1/3 of the knee or reaches the iliac artery; 6. Severe limb infection; 7. History of previous treatment (stent placement); 8. The patient refused.

Design outcomes

Primary

MeasureTime frame
Limb salvage rate;Amputation rate;patency rate;

Secondary

MeasureTime frame
CD-Toll-like receptors;VAS;

Countries

China

Contacts

Public ContactJingdong Tang

Pudong hospital of Fudan University

drtangjingdong@126.com+86 13818226354

Outcome results

None listed

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