Comparing atherectomy plus drug-coated balloon to drug-coated balloon alone for artery disease
Combination Therapy of Atherectomy Plus Drug-coated Balloon Versus Drug-coated Balloon for Complex Femoropopliteal Artery Disease (ARTEMIS Trial)
This study is testing whether combining a special artery cleaning procedure with a drug-coated balloon works better for people with complex artery disease than using the drug-coated balloon alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 19 Years to 85 Years |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05307263 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective, multi-center, randomized, controlled study involving 300 subjects with complex femoropopliteal artery disease. Participants will be randomly assigned to receive either a combination of atherectomy and drug-coated balloon treatment or drug-coated balloon treatment alone. The study aims to evaluate the primary patency at 12 months using Kaplan-Meier survival analysis, with follow-up assessments including ankle-brachial index and imaging studies. The trial focuses on patients with specific complex lesion characteristics, such as long or calcified lesions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 and older with symptomatic peripheral artery disease and complex femoropopliteal artery lesions.
Not a fit: Patients with acute critical limb ischemia or severe hepatic dysfunction 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 disease.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 19 years or older 2. Symptomatic peripheral artery disease: * Moderate or severe claudication (Rutherford category 2 or 3) * Critical limb ischemia (Rutherford category 4 or 5) 3. Femoropopliteal artery disease (stenosis \> 50%) with one of following complex lesion characteristics: - long lesion (\>150 mm), in-stent restenosis, calcified lesion (PACCS grade 2-4) 4. Femoropopliteal artery lesions that operators consider appropriate for treatment with both atherectomy plus drug-coated balloons and drug-coated balloons alone 5. Patients with signed informed consent Exclusion Criteria: 1. Acute critical limb ischemia 2. Severe critical limb ischemia (Rutherford category 6) 3. Contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agents due to severe hypersensitive reactions 4. Age \> 85 years 5. Severe hepatic dysfunction (\> 3 times normal reference values) 6. Significant thrombocytopenia, anemia, or known bleeding diathesis 7. LVEF \< 35% or clinically overt congestive heart failure 8. Pregnant women or women with potential childbearing 9. Life expectancy \<1 year due to comorbidity 10. Previous bypass surgery in the target femoropopliteal artery 11. Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)
Where this trial is running
Seoul
- Yonsei University Health System, Severance Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Young-Guk Ko, MD, PhD
- Email: ygko@yuhs.ac
- Phone: 82-2-2228-8460
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.