Treatment of complex femoropopliteal artery lesions with drug-coated balloons

Clinical Efficacy for the Treatment of Complex Femoropopliteal Artery Lesions Using Drug-coated PTA Balloon：a Real-world Registry Study(CARPLAY-DCB Study)

This study is testing how well drug-coated balloons can treat complex artery problems in patients with peripheral arterial disease in China.

Quick facts

• Study type: Observational
• Enrollment: 838 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05616520 on ClinicalTrials.gov

What this trial studies

This observational study aims to collect clinical data on the use of drug-coated balloons (DCBs) for treating complex femoropopliteal artery lesions in patients with peripheral arterial disease (PAD) in China. It focuses on patients with specific lesion characteristics and will involve regular clinical follow-ups to assess safety and efficacy in a real-world setting. The study seeks to standardize diagnosis and treatment protocols while enhancing understanding of DCB applications in the Chinese population.

Who should consider this trial

Good fit: Ideal candidates include patients with Rutherford grade 2-5 femoropopliteal artery disease and specific complex lesion characteristics.

Not a fit: Patients with less severe arterial disease or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes for patients with complex femoropopliteal artery lesions by providing evidence-based guidelines for the use of drug-coated balloons.

How similar studies have performed: Previous studies have shown promising results with drug-coated balloons for peripheral artery disease, indicating potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Rutherford grade 2-5.
2. 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)
3. Patients who understand the purpose of this study, volunteer to participate in the experiment, sign informed consent and are willing to follow up.
4. The guidewire needs to pass through the lesion.
5. Life expectancy\> 24 months.
6. Patients who received DCB intervention after thrombus removal through PMT or CDT.
7. Patients who have received DCB intervention for both lower limbs can be enrolled in the group according to the intracavitary treatment time.
8. There is at least one continuous below-the-knee outflow artery or obtained by endovascular reconstruction.
9. For patients combined aortic iliac artery disease, the inflow can be recanalized after endovascular reconstruction without illiac residual stenosis exceeding 50%.

Exclusion Criteria:

1. Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage or myocardial infarction within 3 months before enrollment.
2. Patients who are known to be allergic to heparin, aspirin, other antiplatelet drugs, contrast agents, etc.
3. Patients who have participated in clinical trials of drugs or other medical devices that interfere with this clinical trial within the past 3 months.
4. Pregnant and lactating women.
5. Patients who are unable or unwilling to participate in this trial.
6. Patients with Buerger's disease.
7. Patients who have undergone arterial bypass on the treatment side.

Where this trial is running

Beijing, Beijing

• Xuanwu Hospital, Capital Medical University — Beijing, Beijing, China (Recruiting)

Study contacts

• Study coordinator: Lianrui Guo, MD.

Conditions Peripheral Arterial Disease; drug-coated balloon