NCT05307263 Combination Therapy of Atherectomy Plus Drug-coated Balloon Versus Drug-coated Balloon for Complex Femoropopliteal Artery Disease
| NCT ID | NCT05307263 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yonsei University |
| Condition | Femoropopliteal Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-09-15 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2022-09-15 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
* Prospective, multi-center, randomized, controlled comparison study * A total of 300 subjects with complex femoropopliteal artery disease will be included according to inclusion and exclusion criteria. Complex lesions include long lesions (\>150 mm), calcified lesions (PACSS grade 2-4) and in-stent lesions. * Patients will be randomized in a 1:1 manner into atherectomy plus drug-coated balloon (DCB) or angiography-guided intervention group. • The randomization will be startified by the participating center and in-stent restenosis lesion. • For the DCB treatment, either IN.PACT (Medtronic) or Ranger (Boston Scientific) DCB will be used. • For the atherectomy, HawkOne (Medtronic), Jetstream (Boston scientific), or Rotarex (Straub Medical) will be used. • The primary endpoint is primary patency at 12 months based on Kaplan-Meier survival analysis. • Ankle-brachial index and Image study follow-up (Duplex US, CT angiography, or catheter angiography) will be performed at 1 year. * Patients will be followed clinically for 2 years after the procedure.
Eligibility 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05307263 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 85 Years, studying Femoropopliteal Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05307263 currently recruiting?
Yes, NCT05307263 is actively recruiting participants. Contact the research team at ygko@yuhs.ac for enrollment information.
Where is the NCT05307263 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05307263 clinical trial?
NCT05307263 is sponsored by Yonsei University. The trial plans to enroll 300 participants.