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NCT Number: NCT05307263

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

* 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.

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Key information

Conditions

Femoropopliteal Artery Disease

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Young-Guk Ko, MD, PhD

CONTACT

[email protected]

82-2-2228-8460

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 19 years or older
  • Symptomatic peripheral artery disease:
  • Moderate or severe claudication (Rutherford category 2 or 3)
  • Critical limb ischemia (Rutherford category 4 or 5)
  • 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)
  • Femoropopliteal artery lesions that operators consider appropriate for treatment with both atherectomy plus drug-coated balloons and drug-coated balloons alone
  • Patients with signed informed consent

Exclusion criteria

  • Acute critical limb ischemia
  • Severe critical limb ischemia (Rutherford category 6)
  • Contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agents due to severe hypersensitive reactions
  • Age > 85 years
  • Severe hepatic dysfunction (> 3 times normal reference values)
  • Significant thrombocytopenia, anemia, or known bleeding diathesis
  • LVEF < 35% or clinically overt congestive heart failure
  • Pregnant women or women with potential childbearing
  • Life expectancy <1 year due to comorbidity
  • Previous bypass surgery in the target femoropopliteal artery
  • Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)

Treatment and study plan

Combination therapy of atherectomy and DCB

Procedure

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

Procedure

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.

Primary outcomes

  1. Primary patency

    Time frame: 12 months post treatment

    Primary patency is defined as absence of restenosis >50% by Duplex ultrasound, CT angiography, or catheter-based angiography

Study contacts

Contact information is provided by the study sponsor or research team.

Young-Guk Ko, MD, PhD

CONTACT

[email protected]

82-2-2228-8460

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

Combination Therapy of Atherectomy Plus Drug-coated Balloon Versus Drug-coated Balloon for Complex Femoropopliteal Artery Disease (ARTEMIS Trial)

Acronym: ARTEMIS

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Apr 1, 2022
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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