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Percutaneous mechanical thrombectomy and drug coated balloon to treat femoropopliteal artery stent restenosis: a multi-centered, prospective, randomized controlled trial

Percutaneous mechanical thrombectomy and drug coated balloon to treat femoropopliteal artery stent restenosis: a multi-centered, prospective, randomized controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041380
Enrollment
Unknown
Registered
2020-12-24
Start date
2020-05-01
Completion date
Unknown
Last updated
2021-03-08

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

Conditions

Peripheral Vascular Disease

Interventions

mechanical thrombectomy and drug coated balloon:mechanical thrombectomy and drug coated balloon
common balloon+drug coated balloon:common balloon+drug coated balloon

Sponsors

Beijing Friendship Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 80 Years

Inclusion criteria

Inclusion criteria: 1. The patient signs the informed consent; 2. Previous femoral popliteal artery stenting due to lower extremity arteriosclerosis obliterans; 3. The stents were self-expanding and bare metal stents. 4. The stent was completely occluded. 5. The main symptoms is severe Intermittent claudication or resting pain or ulcers or gangrene 6. Good proximal inflow tract; 7. Good distal outflow tract (with 2 or more infrapopliteal arteries); 8. Good compliance, follow-up can be conducted.

Exclusion criteria

Exclusion criteria: 1. Older than 80 years; 2. Acute femoral popliteal artery in-stent thrombosis; 3. Cerebral infarction or/and myocardial infarction in the last 3 months; 4. Patients with malignant tumors; 5. Severe hepatic insufficiency; 6. There are contraindications for antiplatelet and anticoagulation; 7. Abnormal of Protein C, protein S, antithrombin III, anti-cardiolipin antibodies; 8. Blood pressure, blood sugar, blood lipid control is not satisfied; Unable to quit smoking completely.

Design outcomes

Primary

MeasureTime frame
Incidence of target vessel restenosis;

Secondary

MeasureTime frame
Success rate of operation;Remedial Stent Placement;Target lesion revascularization rate;Limb amputation rate;Ulcer healing rate;Pain-free walking distance;ABI;

Countries

China

Contacts

Public ContactFeng Hai

Beijing Tropical Medicine Research Institute

Fenghai543@126.com+86 15810581273

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 14, 2026