Clinical trial NCT05307263: Combination Therapy of Atherectomy Plus Drug-coated Balloon Versus Drug-coated Balloon for Complex Femoropopliteal Artery Disease
Official title: Combination Therapy of Atherectomy Plus Drug-coated Balloon Versus Drug-coated Balloon for Complex Femoropopliteal Artery Disease (ARTEMIS Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Femoropopliteal Artery Disease
Keywords: Femoropopliteal artery disease
drug-coated balloon
angioplasty
atherectomy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 300
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Primary outcomes:
measure: Primary patency
timeFrame: 12 months post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
References: