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Clinical Trials in South Korea / NCT05307263
Recruiting Not applicable

Combination Therapy of Atherectomy Plus Drug-coated Balloon Versus Drug-coated Balloon for Complex Femoropopliteal Artery Disease

NCT05307263 · tracked via the Priya Life Science South Korea tracker
Sponsor
Yonsei University
Phase
Not applicable
Started
2022-09-15
Last updated
2025-05-04

Condition(s) studied

Femoropopliteal Artery Disease

Investigational drug(s) / intervention(s)

Combination therapy of atherectomy and DCBDCB alone

Combination therapy of atherectomy and DCB: The target lesion in femoropopliteal artery will be treated with atherectomy folloewd by DCB. The choice of atherectomy devices (HawkOne, Jectstream, or Rotarex)and DCBs (IN.PACT or Ranger) will be left to the operator's decision. In presence of ≥ 50% residual stenosis or flow limiting dissections, implantation of bare nitinol stents is recommended. Implantational of drug-eluting stents is not allowed.

DCB alone: The target lesion in femoropopliteal artery will be treated with DCB. The choice of DCBs (IN.PACT or Ranger) will be left to the operator's decision. In presence of ≥ 50% residual stenosis or flow limiting dissections, implantation of bare nitinol stents is recommended. Implantational of drug-eluting stents is not allowed.

Study 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

Sex
ALL
Min age
19 Years
Max age
85 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Primary patency — 12 months post treatment
    Primary patency is defined as absence of restenosis \>50% by Duplex ultrasound, CT angiography, or catheter-based angiography

Trial sites (1)

FacilityCityRegionStatus
Yonsei University Health System, Severance Hospital Seoul South Korea Recruiting

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Other trials for the same condition

Safety and Effectiveness of GENOSS PCB in Patients With Long Femoropopliteal Lesion Recruiting
Clinical Outcomes of GENOSS PCB for Femoropopliteal Artery Disease Enrolling by invitation
One-Year Results of GENOSS PCB Real-World Study in Femoropopliteal Artery Disease Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05307263 on ClinicalTrials.gov ↗ ← All trials in South Korea