NCT05961787

A Trial of DCB vs DES in the Treatment of de Novo Large Diameter Coronary Atherosclerotic Stenosis(LARGE ONE)

LARGE-ONE: A Prospective, Multicenter, Randomized Controlled Trial of the Use of Drug-coating Balloons(DCB) or Drug-eluting Stents(DES) in the Treatment of Large Diameter Coronary Atherosclerotic Lesions

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

For the treatment of primary large-diameter coronary atherosclerosis through percutaneous coronary intervention (PCI), the use of a drug balloon (DCB) is not inferior to the placement of a drug-eluting stent (Firehawk™ family). \* Large-diameter vessels were defined as vessels with a diameter of ≥3.00 mm and ≤ 4.0mm

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	SeQuent® Please drug coating balloon(DCB)，Firehawk family drug eluting stent(DES)	Investigation on DCB vs DES on Symptomatic or silent ischemic coronary artery disease with indications for PCI * Lesions ≤35 mm in length (visual), diameter 3-4 mm. * A maximum of 2 target lesions on 2 major epicardial coronary target vessels can be treated during baseline procedure. (e.g., one target lesion on one target vessel, or two target lesions on the same target vessel but separated ≥ 15 mm; Or 1 target lesion on each of the target vessels)

Timeline

• Start date: 2022-12-30
• Primary completion: 2025-01-01
• Completion: 2026-01-01
• First posted: 2023-07-27
• Last updated: 2023-07-27

Locations

1 site across 1 country: China