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Cutting ballon combined with drug-coated ballon versus simple cutting ballon and simple drug-coated ballon for the treatment of femoral-popliteal arteriosclerotic occlusive disease, a randomiazed, controlled prospective study

Cutting ballon combined with drug-coated ballon versus simple cutting ballon and simple drug-coated ballon for the treatment of femoral-popliteal arteriosclerotic occlusive disease, a randomiazed, controlled prospective study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026879
Enrollment
Unknown
Registered
2019-10-25
Start date
2020-01-01
Completion date
Unknown
Last updated
2019-10-28

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

Conditions

atherosclerotic occlusive disease of the lower extremities

Interventions

1:cutting ballon combined with drug-coated ballon
2:simple cutting ballon
3:simple drug-coated ballon

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years old; both male and female are adimitted; 2. Diagnosed with femoral-popliteal atherosclerotic occlusive disease, whose cumulative length of lesion is less than 10cm by computed tomogrraphic angiography (CTA). 3. Rutherford category 2-5; 4. Possess operation indication; 5. Treatment and follow-up should be voluntary and a informed consent form would be signed by the patient or legal guardian.

Exclusion criteria

Exclusion criteria: 1) Patients have a paclitaxel allergy or a iodine allergy; 2) Operation contraindications; 3) Patient with current medical condition with a life expectancy less than 3 months; 4) The patient had sympomatic myoinfarction within 3 months or uncontrollable heart failure; 5) The patient had severe respiratory failure (PO250 mmHg); 6) The patient had renal failure with creatine level more than 200 umol/L; 7) The patient had severe liver disfunction with alanine aminotransferase level over 3 times.

Design outcomes

Primary

MeasureTime frame
primary patency rate;

Secondary

MeasureTime frame
ABI;Rutherford category;late lumen loss;all-cause mortality;rate of target lesion revascularization;rate of target vessel revascularization;

Countries

China

Contacts

Public ContactZhang Xuemin

Peking University People's Hospital

zhangxuemin128@126.com+86 13910990996

Outcome results

None listed

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