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Not Yet Recruiting NCT05616520

Treatment of Complex Femoropopliteal Artery Lesions Using Drug-coated PTA Balloon

Conditions: Peripheral Arterial Disease

Sex: All
Ages: 18 Years – N/A
Enrollment: 600
Sponsor: Xuanwu Hospital, Beijing

Summary

Although DCBs had been widely applicable after registration, there are still lack of clinical data and evidence in the real world condition of Chinese population. This data collection aims to perform regularly clinical follow up to guide the standardized diagnosis and treatment of patients post-operatively, in order to achieve the maximum clinical benefits of these patients, as well as improve the development of the field of peripheral artery disease treated by drug-coated balloon.

Eligibility Criteria

Inclusion Criteria:Rutherford grade 2-5.Femoropopliteal artery disease (stenosis > 50%) with at least one of following complex lesion characteristics: - long lesion (>150 mm), CTO(>50 mm),in-stent restenosis(Tosaka Ⅱ、Ⅲ), calcified lesion (PACCS grade 2-4)Patients who understand the purpose of this study, volunteer to participate in the experiment, sign informed consent and are willing to follow up.The guidewire needs to pass through the lesion.Life expectancy> 24 months.Patients who received DCB intervention after thrombus removal through PMT or CDT.Patients who have received DCB intervention for both lower limbs can be enrolled in the group according to the intracavitary treatment time.There is at least one continuous below-the-knee outflow artery or obtained by endovascular reconstruction.For patients combined aortic iliac artery disease, the inflow can be recanalized after endovascular reconstruction without illiac residual stenosis exceeding 50%.Exclusion Criteria:Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage or myocardial infarction within 3 months before enrollment.Patients who are known to be allergic to heparin, aspirin, other antiplatelet drugs, contrast agents, etc.Patients who have participated in clinical trials of drugs or other medical devices that interfere with this clinical trial within the past 3 months.Pregnant and lactating women.Patients who are unable or unwilling to participate in this trial.Patients with Buerger's disease.Patients who have undergone arterial bypass on the treatment side.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05616520). StuddyBuddy aggregates publicly available trial information.