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NCT05096442Completed

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

A Multicenter, Prospective, Randomized, Single-blind, Pivotal Clinical Study to Evaluate the Safety and Efficacy of GENOSS® DCB Versus SeQuent® Please NEO in Patients With Coronary De Novo Lesions

Source: ClinicalTrials.gov · Last updated 17 May 2024

Brief summary (registry, in English)

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).

Status (registry)
Completed
Study type
Interventional
Enrollment
204 (actual)
First submitted
14 Oct 2021
Start date
30 Sept 2021
Primary completion date
28 Jun 2023
Lead sponsor
Genoss Co., Ltd.
NCT number
NCT05096442

What you commit to

  • Study type: Interventional
  • Participants enrolled: 204
  • From 30 Sept 2021 to the primary completion date, 28 Jun 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with ST-segment elevation myocardial infarction (STEMI)
  • Patients with a history of cardiogenic shock
  • Patients who have or currently have medical conditions such as psychiatric disorders that significantly affect this clinical trial

Lab values

  • 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)

Other

  • Patients who are contraindicated in aspirin, heparin, ticagrelor, iopromide, clopidogrel, prasugrel and paclitaxel
  • Pregnant or lactating women
  • The patients have a life expectancy of less than 12 months
  • 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
  • Patients with one of the following items after pre-dilation of the target lesion
    • When FFR (Functional measurement) is measured as ≤ 0.8 in large vessels with a reference vessel diameter exceeding 2.75mm (However, depending on the judgment of the investigator, FFR measurement may not be performed.)
    • Patients who need stenting due to vascular dissection that restricts blood flow
    • Residual stenosis \> 30%
    • TIMI flow \< 3

Who the study is looking for

  • 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.

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ulsan University Hospital
Coordinator of this site? Confirm its status
UlsanSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.