- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05096442
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In a randomized controlled trial to compare with the same-category drug device (SeQuent® Please NEO), 204 patients with coronary de novo lesions were recruited from a total of 12 institutions, and the enrolled subjects were 1: 1 through randomization.
The ratio was assigned to the test group and the control group, and each of the test or control devices was assigned to receive the procedure.
The primary end point is the in-lesion late lumen loss of the target lesion at 6 months after the procedure, and the secondary end point is the target vessel failure (Composite of cardiac death, TV-MI, and ID-TVR) at 6 and 12 months after the procedure.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ulsan, Korea, Republic of
- Ulsan University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Inclusion criteria for coronary angiography
- 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.
Exclusion Criteria:
- 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
Exclusion criteria for coronary angiography
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Genoss® DCB
Paclitaxel Coated PTCA Balloon Catheter
|
Drug Coated Balloon
Other Names:
|
Active Comparator: SeQuent® Please NEO
Paclitaxel Coated PTCA Balloon Catheter
|
Drug Coated Balloon
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
in-lesion late lumen loss after percutaneous coronary intervention in patients with coronary de novo lesions
Time Frame: Follow-up angiography at 6 months after the procedure
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Restenosis rate after percutaneous coronary intervention in patients with coronary de novo lesions
Time Frame: Follow-up angiography at 6 months after procedure
|
Restenosis is defined as a case where the DS(Diameter stenosis) of the reference vessel diameter is 50% or more when the successfully treated lesion is evaluated through coronary angiography.
|
Follow-up angiography at 6 months after procedure
|
Target vessel failure(TVF)
Time Frame: at 6 and 12 months after the procedure
|
Composite of TVF(cardiac death, TV-MI, and ID-TVR)
|
at 6 and 12 months after the procedure
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eun-Seok Shin, MD, PhD, Division of Cardiology, Ulsan University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- CEP-DS1001_DN
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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