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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 procedure in patients with in-stent restenosis (ISR) compared with a product of the same category (Sequent® Please)
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 enrolled subjects were 1: 1 through randomization. The ratio was assigned to the test group and the control group, and each of the test or control devices was assigned to receive the procedure.
Drug release "stents" for PCI usually follow 9 months or 12 months, but the medical device for this clinical trial has a drug coated "balloon catheter" and the mechanism of action is different from the stent and the duration of follow up was set to 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genoss® DCB | Experimental | Paclitaxel Coated PTCA Balloon Catheter |
|
| SeQuent® Please | Active Comparator | Paclitaxel Coated PTCA Balloon Catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel Coated PTCA Balloon Catheter | Device | Drug coated balloon |
|
| Measure | Description | Time Frame |
|---|---|---|
| In-segment late lumen loss after percutaneous coronary intervention in patients with ISR | In-segment late lumen loss between test group(Genoss DCB) and control group(Sequent Please) evaluated by quantitiative coronary analysis in patients with ISR | Follow-up angiography at 6 months after procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36339121 | Derived | Jun EJ, Shin ES, Yuan SL, Bhak Y, Garg S, Kang WC, Kim JS, Kim JH, Bae JW, Rha SW, Chae IH. Comparison of 2 Different Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis: A Randomized Controlled Trial. JACC Asia. 2022 Mar 1;2(2):170-179. doi: 10.1016/j.jacasi.2021.11.015. eCollection 2022 Apr. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |