Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions

NCT05096442 | Completed

• 1 other identifier: CEP-DS1001_DN
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of a novel Paclitaxel-coated balloon (Genoss® DCB) by demonstrating non-inferiority to in-lesion late lumen loss at 6 months after the procedure in Korean patients with coronary de novo lesions compared with a product of the same category (SeQuent® Please NEO).

Conditions

Coronary Artery Disease

Keywords

de novo lesions

Outcome Measures

Primary Outcomes (1)

• in-lesion late lumen loss after percutaneous coronary intervention in patients with coronary de novo lesions

  late lumen loss between test group and control group evaluated by quantitative coronary analysis in patients with coronary de novo lesions

  Follow-up angiography at 6 months after the procedure

Secondary Outcomes (2)

• Restenosis rate after percutaneous coronary intervention in patients with coronary de novo lesions

  Follow-up angiography at 6 months after procedure

• Target vessel failure(TVF)

  at 6 and 12 months after the procedure

Study Arms (2)

Genoss® DCB

EXPERIMENTAL

Paclitaxel Coated PTCA Balloon Catheter

Device: GENOSS® DCB

SeQuent® Please NEO

ACTIVE COMPARATOR

Paclitaxel Coated PTCA Balloon Catheter

Device: SeQuent® Please NEO

Interventions

GENOSS® DCB DEVICE

Drug Coated Balloon

Also known as: Paclitaxel Coated PTCA Balloon catheter

Genoss® DCB

SeQuent® Please NEO DEVICE

Drug Coated Balloon

Also known as: Paclitaxel Coated PTCA Balloon catheter

SeQuent® Please NEO

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥19 years old
• Patients requiring PCI with coronary de novo lesions
• Patients with stable angina pectoris, or unstable angina pectoris, and asymptomatic myocardial ischemia
• Women of childbearing age who agreed to use one or more of the clinically appropriate methods of contraception during the trial period.
• In case of voluntarily deciding to participate in this clinical trial by signing the informed consent form
• Patients with significant coronary artery stenosis (\> 50% diameter stenosis on coronary angiography)
• On coronary angiography, the length of the lesion is less than 34 mm and the diameter of the reference vessel of the coronary artery is 2.0 - 4.0mm.

You may not qualify if:

• Patients with ST-segment elevation myocardial infarction (STEMI)
• Patients who are contraindicated in aspirin, heparin, ticagrelor, iopromide, clopidogrel, prasugrel and paclitaxel
• Patients with platelet aggregation or disorders at risk of increased bleeding, such as gastrointestinal ulcers, which limit platelet aggregation inhibitory therapy and anticoagulant therapy
• Patients with a left ventricular ejection fraction of less than 30% on echocardiography
• Patients with renal insufficiency (eGFR\<30mL/min)
• Patients with a history of cardiogenic shock
• Pregnant or lactating women
• The patients have a life expectancy of less than 12 months
• Patients who have or currently have medical conditions such as psychiatric disorders that significantly affect this clinical trial
• Patients who, in the investigator's judgment, may not be suitable for this clinical trial or may increase the risk associated with participation in the study
• Patients who are currently participating in other clinical trials or have experience participating in other clinical trials within 90 days from the screening date
• Patients who are unsuitable for the study according to the investigator judges
• Patients with left main coronary lesion
• Patients with graft vessel lesion
• Patients who cannot apply pre-dilation or fail in pre-dilation to apply medical devices for clinical trials

Sponsors & Collaborators

• Genoss Co., Ltd.: lead

Study Sites (1)

Ulsan University Hospital

Ulsan, South Korea

Location

Related Publications (1)

• Shin ES, Park Y, Lee JY, Her AY, Chon MK, Kim S, Rha SW, Oh GC, Cho DK, Kim B, Bae JW. A Prospective Randomized Trial Comparing 2 Different Paclitaxel-Coated Balloons in De Novo Coronary Artery Disease. JACC Asia. 2025 Jan 7;5(1):15-24. doi: 10.1016/j.jacasi.2024.10.028. eCollection 2025 Jan.

  PMID: 39886190 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Eun-Seok Shin, MD, PhD

  Division of Cardiology, Ulsan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: October 27, 2021
• Study Start: September 30, 2021
• Primary Completion: June 28, 2023
• Study Completion: November 21, 2023
• Last Updated: May 17, 2024

Record last verified: 2024-01

Locations

KR (1)