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| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
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This is a multicenter, prospective randomized controlled study to evaluate the safety and effectiveness of Sirolimus-coated spiral balloon (SuperFlow®) versus Paclitaxel-coated balloon (Bingo™) in the treatment of coronary bifurcation lesions.
This is a prospective, multicenter, randomized controlled, non-inferiority trial conducted across 13-20 sites. The study aims to enroll 280 patients with true coronary bifurcation lesions in native coronary arteries.
Eligible patients will be randomized in a 1:1 ratio to receive either the Sirolimus-coated spiral balloon (SuperFlow®) or the Paclitaxel-coated balloon (Bingo™), following a site-specific blocked randomization schedule.
All participants will be screened based on the trial's predefined inclusion and exclusion criteria. Data and imaging will be collected during the index procedure and at the predefined 9-month clinical follow-up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sirolimus-coated spiral balloon (SuperFlow®) | Experimental | A PTCA spiral balloon catheter with sirolimus coating (3ug/mm^2) on balloon surface |
|
| Paclitaxel-coated balloon (Bingo™） | Active Comparator | A PTCA balloon catheter with paclitaxel coating (3ug/mm^2) on balloon surface |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirolimus coated balloon angioplasty | Combination Product | This study involves the use of a Sirolimus-Coated Balloon (SCB) for the treatment of coronary artery disease, specifically targeting coronary bifurcation lesions. The SCB is coated with sirolimus, an antiproliferative drug that helps to prevent restenosis by inhibiting smooth muscle cell proliferation. The balloon is inflated at the target lesion site, delivering the drug directly to the arterial wall. This intervention aims to achieve vessel dilation while reducing the risk of restenosis, providing a potential alternative to stent placement. |
| Measure | Description | Time Frame |
|---|---|---|
| Diameter stenosis (%) | Percentage of target vessel stenosis per angiographic measurement at 6 months follow up | 6 months (±30 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Interventional success rate | Including device success, lesion success, and clinical success Device Success: Includes successful delivery of the device and successful treatment. Successful Delivery: Successful delivery of the designated device to the lesion and release, with the delivery system retracting smoothly. Successful Treatment: Immediately post-procedure, residual stenosis of the target lesion is less than 50% with TIMI grade 3 flow (visual assessment). Lesion Success: After any interventional treatment, residual stenosis of the target lesion is less than 50% with TIMI grade 3 flow (visual assessment). Clinical Success: Based on lesion success, no major adverse cardiac events occurred during hospitalization (up to 7 days post-procedure). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuying Bi | Contact | +86 22215363 | ybi@ttmedicalinc.com |
| Name | Affiliation | Role |
|---|---|---|
| Tim Wu, MD, PhD | Dongguan TT Medical | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
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| Paclitaxel coated balloon angioplasty | Combination Product | This study involves the use of a Paclitaxel-Coated Balloon (PCB) for the treatment of coronary artery disease, specifically targeting coronary bifurcation lesions. The PCB is coated with paclitaxel, an antiproliferative drug that helps to prevent restenosis by inhibiting smooth muscle cell proliferation. The balloon is inflated at the target lesion site, delivering the drug directly to the arterial wall. This intervention aims to achieve vessel dilation while reducing the risk of restenosis, providing a potential alternative to stent placement. |
|
| Immediate post procedure (device and lesion success), and up to 7 days post-procedure (clinical success) |
| Quantitative Flow Ratio (QFR) | In the presence of stenotic lesions in the coronary artery, the ratio of the maximum blood flow that the artery can deliver to the myocardial region to the maximum blood flow that could theoretically be obtained in that region under normal conditions. | 9 months (±30 days) |
| Rate of restenosis | Coronary angiography results showing a diameter stenosis of ≥50% are considered indicative of restenosis. | 9 months (±30 days) |
| Late lumen loss (LLL) | The difference between the minimum lumen diameter of the target lesion segment immediately post-procedure and the minimum lumen diameter of the same segment during the angiographic follow-up at 9 months post-procedure. | 9 months (±30 days) |
| Target lesion revascularization (TLR) | Including repeat PCI with stent implantation, balloon angioplasty, plaque atherectomy, or coronary artery bypass grafting (CABG) | 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days) |
| Target vessel revascularization (TVR) | Including repeat PCI with stent implantation, balloon angioplasty, plaque atherectomy, or CABG | 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days) |
| Target lesion failure (TLF) rate | Including cardiac death, target vessel-related myocardial infarction, and target lesion revascularization | 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days) |
| Thrombotic event rate | Rate of thrombosis | 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days) |
| Major adverse cardiac events (MACE) rate | Including all-cause death, all myocardial infarctions, and all repeat revascularizations | 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days) |
| Adverse events (AEs) and serious adverse events (SAEs) rate | Rate of AEs or SAEs | 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days) |
| Device defect rate | Rate of device defect | Immediate post procedure |