Status:
ENROLLING_BY_INVITATION
The Safety and Efficacy for In-segment Late Lumen Loss of the 'Genoss® SCB' Versus 'SeQuent® Please NEO' in Patients With Coronary ISR
Lead Sponsor:
Genoss Co., Ltd.
Collaborating Sponsors:
Synex Consulting Ltd
Conditions:
Coronary Arterial Disease (CAD)
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
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 ...
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 g...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
February 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT07159087
Start Date
February 19 2025
End Date
January 31 2027
Last Update
September 8 2025
Active Locations (1)
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1
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea, 13620