The Safety and Efficacy for In-segment Late Lumen Loss of the 'Genoss® SCB' Versus 'SeQuent® Please NEO' in Patients With Coronary ISR

Official title

A Multicenter, Prospective, Randomized, Double-blind, Pivotal Clinical Trial to Compare the Safety and Efficacy for In-segment Late Lumen Loss of the 'Genoss® SCB' Versus 'SeQuent® Please NEO' in Patients With Coronary ISR

Overview

The objective of this study is to evaluate the safety and effectiveness of Genoss® SCB by comparing in-segment late lumen loss (LLL) to the control group (SeQuent® Please NEO) at 6 months in patients with coronary stent-in-stent restenosis (ISR) with a reference vessel diameter of 2.0-4.0 mm.

Detailed description

This pivotal study is a randomized controlled trial to compare with the control group (SeQuent® Please NEO), and will recruit 94 patients with in-stent restenosis (ISR) from 9 institutions. The test group (Genoss® SCB) and the control group (SeQuent® Please NEO) will be randomly assigned 1:1, and all patients will be followed up at 1, 6, and 12 months after the procedure. The primary endpoint is to evaluate in-segment late lumen loss by quantitative coronary angiography (QCA) by an independent assessor at 6 months after the procedure.

Interventions

• Device Sirolimus Coated PTCA Balloon Catheter(Genoss® SCB)
  Drug Coated Balloon
• Device Paclitaxel Coated PTCA Balloon Catheter(SeQuent® Please NEO)
  Drug Coated Balloon

Primary outcome measures

• In-segment late lumen loss after procedure [Time frame: at 6 months after procedure]

Secondary outcome measures (12)

• In-stent late lumen loss after procedure [Time frame: at 6 months after procedure]
• Target Lesion Failure (TLF), % [Time frame: at 1 month, 6 months, and 12 months after procedure]
• Patient-oriented composite endpoint (POCE), % [Time frame: at 1 month, 6 months, and 12 months after procedure]
• Device success rate, % [Time frame: Immediately after the procedure]
• Procedural success rate, % [Time frame: up to 24 hours]
• Binary restenosis rate, % [Time frame: at 6 months after procdure]
• Cardiac Death, % [Time frame: at 1 month, 6 months, and 12 months after procedure]
• All-cause death, % [Time frame: at 1 month, 6 months, 12 months after procedure]
• Target vessel myocardial infarction (TV-MI), % [Time frame: at 1 month, 6 months, and 12 months after procedure]
• Myocardial infarction (MI), % [Time frame: at 1 month, 6 months, and 12 months after procedure]
• Ischemia-driven target lesion revascularization (ID-TLR), % [Time frame: at 1 month, 6 months, and 12 months after procedure]
• Ischemia-driven target vessel revascularization (ID-TVR), % [Time frame: at 1 month, 6 months, and 12 months after procedure]

Eligibility criteria

Inclusion criteria

• ≥ 19 years of age
• Patients with in-stent restenosis who are candidates for percutaneous coronary intervention (PCI)
• In cases corresponding to one of the following conditions: non-ST-segment elevation myocardial infarction (NSTEMI), stable angina, unstable angina, or silent myocardial ischemia
• Women of childbearing potential\* must agree to use at least one medically acceptable method of contraception\*\* throughout the duration of the clinical trial
• Subjects who voluntarily agree to participate and provide written informed consent
• Subjects who are willing to comply with the requirements of the clinical trial protocol
• Subjects who develop in-stent restenosis (ISR) ≥ 90 days after the index coronary stent implantation, with the restenosis classified as Mehran type I to III
• Subjects with a maximum of two ISR lesions, with visually estimated significant coronary artery stenosis on quantitative coronary angiography analysis (QCA) meeting one of the following criteria:

• In asymptomatic patients: in-segment percent diameter stenosis (DS%) > 70% compared to the reference vessel diameter of the target vessel\* (\*Target vessel: the vessel containing the target lesion with the minimum lumen diameter.)
• In patients with angina symptoms or evidence of ischemia on non-invasive functional testing: DS% > 50%
• On QCA, the ISR lesion(s) to be treated must have a lesion length < 36 mm and the reference vessel diameter (RVD) of the target coronary artery must be between 2.0 mm and 4.0 mm.

Exclusion criteria

• Patients diagnosed with ST-segment elevation myocardial infarction (STEMI) by electrocardiogram.
• Known hypersensitivity or contraindications at screening to any of the following drugs or substances: Aspirin, Heparin, Clopidogrel, Prasugrel, Ticagrelor, Sirolimus, Paclitaxel, Delivery matrix (e.g., shellac, vitamin E-TPGS), Ticlopidine, Contrast agents (e.g., Iopromide) Note: Subjects with contrast media sensitivity may be enrolled if the reaction is manageable with steroids and pheniramine; however, those with a known anaphylactic reaction are excluded.
• Subjects who are scheduled for or require surgery within 1 year of the index procedure that would necessitate discontinuation of antiplatelet therapy.
• Subjects with bleeding disorders, gastrointestinal ulcers, or any conditions that may increase the risk of bleeding, in which anticoagulation is contraindicated or limited.
• Subjects with a left ventricular ejection fraction (LVEF) < 30% as assessed by echocardiography.
• Severe renal failure (Creatinine > 2.0 mg/dL) that makes QCA inappropriate.
• Subjects with cardiogenic shock.
• Pregnant or breastfeeding women: Women of childbearing potential with a positive urine hCG (or serum β-hCG) test are excluded.
• Subjects with an estimated life expectancy of less than 1 year due to comorbid conditions.
• Subjects with medical conditions such as significant psychiatric disorders that may interfere with trial participation or outcomes.
• Subjects who, in the investigator's opinion, are inappropriate for this clinical trial or for whom participation poses increased risk.
• Participation in another clinical trial currently or within 90 days prior to screening.
• Any other condition deemed ethically or clinically inappropriate by the investigator to participate in the study: Specific reasons should be recorded in the Case Report Form (CRF).

\[Exclusion Criteria Based on QCA and Pre-Dilatation Assessment of ISR Lesions\]

• ISR lesions located in graft vessels following coronary artery bypass grafting (CABG).
• Presence of coronary stent fracture in the ISR lesion to be treated.
• Target lesion with two or more stents implanted, i.e., all segments of the target lesion contain ≥2 layers of stents.
• Presence of additional lesions proximal or clinically significant distal to the target lesion (>2.0 mm RVD) with >50% stenosis.
• Subjects requiring CABG based on any of the following:

• Lesions in the left main coronary artery.
• Triple-vessel coronary artery disease.
• Other conditions requiring CABG as determined by the investigator.
• Subjects for whom pre-dilatation is not feasible or has failed, making application of the investigational device difficult due to any of the following:

• Total occlusion of the target lesion.
• Evidence of thrombus not treatable with aspiration.
• Severe vessel tortuosity or calcification preventing access to the target site, as determined by the investigator.
• Other conditions deemed unsuitable for investigational device application by the investigator.
• After lesion pre-dilatation, if any of the following are present:

• Need for atherectomy (rotational, orbital, or laser).
• Presence of flow-limiting dissection of NHLBI type C or higher requiring stent implantation.
• Residual stenosis\* in the target lesion. (\*Defined as in-segment DS > 30%)
• Fractional flow reserve (FFR) ≤ 0.8 (FFR measurement may be omitted at the discretion of the investigator.)
• TIMI flow < 3

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

South Korea · 1 center

• Seoul National University Bundang Hospital — Gyeonggi-do

Identifiers

NCT: NCT07159087 · CEP-DS2201

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗