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

Femoropopliteal Artery Disease Clinical Trial

— ARTEMIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05307263
• Other study ID #: 4-2022-0051
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: June 2027

Study information

• Verified date: December 2023
• Source: Yonsei University
• Contact: Young-Guk Ko, MD, PhD
• Phone: 82-2-2228-8460
• Email: ygko[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Femoropopliteal Artery Disease

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patency	Primary patency is defined as absence of restenosis >50% by Duplex ultrasound, CT angiography, or catheter-based angiography	12 months post treatment