Clinical application of drug coated balloon in stent restenosis after endovascular treatment of lower extremity arteriosclerosis obliterans

Efficacy of drug coated balloon in the treatment of lower extremity arteriosclerosis obliterans in stent restenosis

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2000040920

Enrollment

Unknown

Registered

2020-12-15

Start date

2019-01-01

Completion date

Unknown

Last updated

2021-04-12

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

Conditions

lower extremity arteriosclerosis obliterans

Interventions

1:The lesion was dilated with drug coated balloon

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-85 years; 2. Patients with ASO and Rutherford grade 2-5. 3. Severe stent stenosis (70% or more) or occlusive disease in superficial femoral artery and / or popliteal artery. 4. There should be at least one outflow tract under the knee. 5. The residual stenosis was less than or equal to 30% after pre expansion.

Exclusion criteria

Exclusion criteria: 1. Patients with plasma creatinine level greater than 150umol /L; 2. Patients with acute and subacute thrombosis requiring thrombolysis and thrombectomy; 3. Patients with known allergies to aspirin, heparin, Plavix, paclitaxel, contrast media, etc; 4. Pregnant and lactating women; 5. Patients with previous thrombocytopenic purpura or coagulation dysfunction; 6. Patients with life expectancy less than 12 months.

Design outcomes

Primary

Measure	Time frame
Primary patency;	—

Secondary

Measure	Time frame
Rutherford grading improvement;Ankle brachial index changes;	—

Countries

China

Contacts

Public ContactChaowen Yu

The First Affiliated Hospital of Bengbu Medical College

Doctoryu16@163.com+86 13309651876

Outcome results

None listed

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