Status:
COMPLETED
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please in Korean Patients With Coronary In-stent Restenosis
Lead Sponsor:
Genoss Co., Ltd.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of Paclitaxel-coated balloon (Genoss® DCB) by demonstrating non-inferiority to in-segment late lumen loss at 6 months after the procedu...
Detailed Description
In a randomized controlled trials to compare with the same-category medical device (Sequent® Please), 82 patients with in-stent restenosis (ISR) were recruited from a total of 7 institutions, and the ...
Eligibility Criteria
Inclusion
- Age ≥19 years old
- Patients with significant coronary artery stenosis including left main coronary lesion (\> 50% diameter stenosis on coronary angiography)
- Patients with stable angina pectoris, or unstable angina pectoris, and asymptomatic myocardial ischemia
- Patients suitable to receive coronary revascularization of any type
- Restenosis Mehran type I-III after stent implantation for the first time
- Patients with In-stent restenosis after 90 days of the stent implantation, and the degree of restenosis corresponds to Mehran type I-Ⅲ.
- Diameter of the stent with restenosis should be 2.0-4.0mm (included). Length of the stenosis lesion should be no more than 40mm
- In case of voluntarily deciding to participate in this clinical trial by signing the informed consent form
Exclusion
- Patients with Infarct related artery (IRA) lesions among patients with acute myocardial infarction
- Patients have restenosis lesions with thrombosis
- Patients with a history of cardiogenic shock
- Patients with total occlusion indicating TIMI 0 blood flow at the target lesion (Mehran type IV stenosis)
- Patients with graft vessel lesion
- Patients who are contraindicated in aspirin, heparin, clopidogrel, ticlopidine, and paclitaxel
- Patients with renal insufficiency (eGFR\<30mL/min)
- Pregnant or lactating women
- The patients have a life expectancy of less than 12 months
- Patients who had reduced immunity or clinically significant abnormalities in the laboratory tests (hematological, serum biochemical, and urine tests) performed at the time of screening
- Patients who had clinically significant disorders in cardiovascular system, digestive system, respiratory system, endocrine system, and central nervous system, or mental illness that significantly affects this study
- Patients who are unsuitable for the study according to the investigator judges
Key Trial Info
Start Date :
November 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2019
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04405063
Start Date
November 1 2016
End Date
February 1 2019
Last Update
May 17 2024
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