Compare the Safety and Effectiveness of Genoss® DCB and SeQuent® Please NEO in Chinese Patients with Coronary ISR

NCT04767022 | Completed

• 1 other identifier: CIP-DS1001-C
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of Genoss® DCB by demonstrating non-inferiority in patients with in-stent restenosis (ISR) compared with a product of the same category (Sequent® Please NEO). The experimental group was treated with Genoss® DCB, and the control group was treated with SeQuent® Please NEO. In this study, the end point of 9 months after procedure was used as the main endpoint to evaluate the effectiveness of Paclitaxel coated PTCA balloon catheter. The safety of the catheter was evaluated by cardiovascular adverse events.

Conditions

Coronary Artery Disease

Keywords

In-Stent Restenosis

Outcome Measures

Primary Outcomes (1)

• In-segment late lumen loss after procedure

  In-segment late lumen loss between test group(Genoss DCB) and control group(Sequent Please) evaluated by quantitiative coronary analysis in patients with ISR

  at 9 months after procedure

Secondary Outcomes (4)

• Device-oriented compoiste endpoint (DOCE)

  at 30 days, 6 months, 9 months, 12 months and 24 months after procedure

• Patient-oriented composite endpoint (POCE)

  at 30 days, 6 months, 9 months, 12 months, and 24 months after procedure

• Stent thrombosis by ARC definition

  at 6 months, 9 months, 12 months, 24 months after procedure

• Retenosis rate

  at 9 months after procedure

Study Arms (2)

Genoss® DCB

EXPERIMENTAL

Paclitaxel Coated PTCA Balloon Catheter

Device: Paclitaxel Coated PTCA Balloon Catheter(Genoss® DCB)

SeQuent® Please NEO

ACTIVE COMPARATOR

Paclitaxel Coated PTCA Balloon Catheter

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

Interventions

Paclitaxel Coated PTCA Balloon Catheter(Genoss® DCB) DEVICE

Drug Coated Balloon

Genoss® DCB

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

Drug Coated Balloon

SeQuent® Please NEO

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18 years old \& ≤80 years old.
• Patients with stable angina pectoris, unstable angina pectoris, stable acute myocardial infarction or confirmed silent myocardial ischemia.
• Patients who can understand the purpose of the study and voluntarily participate in and sign informed consent.
• It is suitable for patients undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
• The target lesions were in stent restenosis: Mehran type I, II and III stenosis.
• The stenosis rate of target lesion diameter was more than 70%, or more than 50%, accompanied by objective evidence of ischemia (such as stress electrocardiogram, myocardial perfusion imaging, FFR, etc.)
• The reference vessel diameter of the target lesion was 2.0-4.0 mm, and the target lesion length was less than or equal to 26 mm.
• It is expected that no more than two drug balloons will be used in each subject, and each target lesion can be covered by one drug balloon.
• At most 2 primary lesions need interventional treatment, and the distance from the target lesion is more than or equal to 10 mm, and can be successfully treated before the intervention of the target lesion.

You may not qualify if:

• A woman who is pregnant, lactating, or planning a pregnancy.
• Patients with cardiogenic shock, acute infection, known bleeding or coagulation disorder, or history of cerebral hemorrhage, subarachnoid hemorrhage, active peptic ulcer and gastrointestinal bleeding within 3 months before operation.
• Patients who are known to be allergic to aspirin, clopidogrel, ticagrelor, heparin, contrast agent, paclitaxel, or have contraindications to aspirin, clopidogrel or ticagrelor.
• Patients with acute myocardial infarction within 1 week before operation.
• Patients with Takayasu arteritis.
• Left ventricular ejection fraction ≤ 30%.
• Acute or chronic renal insufficiency (serum creatinine \> 2.0mg/dl or 178 μ mol / L).
• Patients with life expectancy less than 1 year.
• Patients participating in clinical trials of other drugs or medical devices.
• According to the researcher's judgment, the patient's clinical condition is not suitable for this study, or the patient is expected to be unable to complete the follow-up study according to the protocol.
• The target lesion was total occlusion (Mehran type IV).
• The target and non target lesions were left main artery lesions.
• The target lesions were ostial, pontine and bifurcated lesions with branch diameter ≥ 2.5mm.
• Three vessel disease requiring treatment.
• More than 3 lesions (including target lesions and non target lesions) need to be treated in target vessels.

Sponsors & Collaborators

• Genoss Co., Ltd.: lead

Study Sites (1)

Department of Cardiology, First Affiliated Hospital of Air Force Medical University of Chinese PLA

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ling Tao

  Department of Cardiology, First Affiliated Hospital of Air Force Medical University of Chinese PLA

  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: February 19, 2021
• First Posted: February 23, 2021
• Study Start: January 30, 2021
• Primary Completion: December 20, 2023
• Study Completion: May 30, 2024
• Last Updated: February 21, 2025

Record last verified: 2025-02

Locations

CN (1)