NCT05307263

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Femoropopliteal Artery Disease

Interventions

Type	Name	Description
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.
PROCEDURE	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.

Timeline

• Start date: 2022-09-15
• Primary completion: 2029-06-30
• Completion: 2029-12-01
• First posted: 2022-04-01
• Last updated: 2025-05-04

Locations

1 site across 1 country: South Korea