Comparing atherectomy plus drug-coated balloon to drug-coated balloon alone for artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long femoropopliteal artery disease: GENOSS paclitaxel-coated balloon safety and effectiveness after PTA

  This study tests whether the GENOSS paclitaxel-coated balloon is safe and helps keep the treated leg arteries open in adults with long femoropopliteal lesions after angioplasty.

  Recruiting Genoss Co., Ltd. · Suwon, Gyeonggi-do · NCT07425171

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• Embolic protection to prevent distal embolism during femoropopliteal debulking procedures.

  This study will test whether using an embolic protection system during femoropopliteal debulking can reduce distal embolism in adults with chronic femoropopliteal lesions.

  Recruiting RenJi Hospital · Shanghai, Shanghai Municipality · NCT07282301

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.