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

NCT07159087 | Enrolling By Invitation

• 1 other identifier: CEP-DS2201
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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 with coronary stent-in-stent restenosis (ISR) with a reference vessel diameter of 2.0-4.0 mm.

Conditions

Coronary Arterial Disease (CAD)

Keywords

In-stent Restenosis

Outcome Measures

Primary Outcomes (1)

• In-segment late lumen loss after procedure

  In-segment refers to a portion including within 5 mm of each of the distal and proximal portions at the boundary of the inserted stent. Therefore, in-segment late lumen loss (LLL) is defined as the difference (mm) in the minimum lumen diameter (MLD) within the segment at 6 months from baseline.

  at 6 months after procedure

Secondary Outcomes (17)

• In-stent late lumen loss after procedure

  at 6 months after procedure

• Target Lesion Failure (TLF), %

  at 1 month, 6 months, and 12 months after procedure

• Patient-oriented composite endpoint (POCE), %

  at 1 month, 6 months, and 12 months after procedure

• Device success rate, %

  Immediately after the procedure

• Procedural success rate, %

  up to 24 hours

Study Arms (2)

Genoss® SCB

EXPERIMENTAL

Sirolimus Coated PTCA Balloon Catheter

Device: Sirolimus Coated PTCA Balloon Catheter(Genoss® SCB)

SeQuent® Please NEO

ACTIVE COMPARATOR

Paclitaxel Coated PTCA Balloon Catheter

Device: Paclitaxel Coated PTCA Balloon Catheter(SeQuent® Please NEO)

Interventions

Sirolimus Coated PTCA Balloon Catheter(Genoss® SCB) DEVICE

Drug Coated Balloon

Genoss® SCB

Paclitaxel Coated PTCA Balloon Catheter(SeQuent® Please NEO) DEVICE

Drug Coated Balloon

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:

• ≥ 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.

You may not qualify if:

• 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).
• ISR lesions located in graft vessels following coronary artery bypass grafting (CABG).
• Presence of coronary stent fracture in the ISR lesion to be treated.

Sponsors & Collaborators

• Genoss Co., Ltd.: lead
• Synex Consulting Ltd: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Gyeonggi-do, 13620, South Korea

Location

Study Officials

• In-ho Chea, MD

  Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: September 8, 2025
• Study Start: February 19, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-06

Locations

KR (1)