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

NCT05961787 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2023-07-27

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Shanghai MicroPort Medical (Group) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Ming Zheng, Doctoral · Shanghai MicroPort Medical (Group) Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-30
Primary Completion
2025-01-31
Completion
2026-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05961787 on ClinicalTrials.gov