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

Yonsei University

Status: Enrolling

Conditions: Femoropopliteal Artery Disease

Treatments: Procedure: DCB alone; Procedure: Combination therapy of atherectomy and DCB

Study type: Interventional

Funder types: Other

Identifiers

NCT05307263

4-2022-0051

Details and patient eligibility

About

• 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Atherectomy plus DCB

Active Comparator group

Treatment:

Procedure: Combination therapy of atherectomy and DCB

DCB

Active Comparator group

Treatment:

Procedure: DCB alone