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

Femoropopliteal Artery Disease Clinical Trial

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

Status Recruiting

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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Femoropopliteal Artery Disease

• NCT number: NCT05307263
• Study type: Interventional
• Source: Yonsei University
• Contact: Young-Guk Ko, MD, PhD
• Phone: 82-2-2228-8460
• Email: ygko@yuhs.ac
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2022
• Completion date: June 2027