Coronary Bifurcation Lesion
Conditions
Brief summary
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.
Detailed description
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.
Interventions
COMBINATION_PRODUCTSirolimus coated balloon angioplasty
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.
COMBINATION_PRODUCTPaclitaxel coated balloon angioplasty
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.
Sponsors
Peking University First Hospital
Dongguan TT Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged between 18 and 85 years, regardless of gender. * Patients must voluntarily participate in the study and sign an informed consent form. * Patients must demonstrate sufficient adherence to the study protocol and agree to follow-up visits at 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days) post-procedure, with angiography required at 9 months (±30 days). * Patients must have evidence of myocardial ischemia. * Angiographically confirmed primary coronary bifurcation lesions (Medina classification non-0, 0, 1) with branch stenosis ≥70% (estimated visually). * Patients suitable for PCI where the branch lesion is not expected to require stenting; stenting is planned for the main vessel, with DCB used on the branch. It is recommended to treat the branch with DCB first, followed by main vessel stenting. * Residual stenosis ≤50% after pre-treatment of the branch lesion, TIMI 3 flow, with no dissection or only A or B grade dissection. C grade dissections should be carefully considered by the investigator before deciding, and are generally not included. * The diameter of the branch vessel must be between 2.0 mm and 4.0 mm, with a lesion length ≤40 mm.
Exclusion criteria
* Patients with bleeding disorders or active gastrointestinal ulcers, those who have had a stroke within the past 6 months, or those who are expected to be intolerant to dual antiplatelet therapy post-intervention. * Patients with severe renal insufficiency (creatinine level \> 3.0 mg/dL or 265.2 µmol/L) and/or end-stage renal disease requiring dialysis. * Patients in cardiogenic shock. * Patients who have experienced a myocardial infarction within the week prior to enrollment. * Patients with severe congestive heart failure or NYHA class IV severe heart failure. * Patients with severe valvular heart disease. * Patients who have undergone heart transplantation. * Patients with a life expectancy of less than 1 year. * Patients currently participating in other drug or device clinical trials that have not yet reached the primary endpoint. * Patients with contraindications to taking aspirin and/or clopidogrel and/or ticagrelor. * Patients known to be allergic to paclitaxel, rapamycin, contrast agents, etc. * Pregnant or breastfeeding women, those with plans to conceive within the year, or those unwilling to use effective contraception. * Target vessels that are completely occluded, severely calcified, have \>45° angulation, or are non-protected left main lesions. * Non-target lesions that cannot be treated prior to or fail to be treated successfully before addressing the target lesion. * Target lesions in branch vessels that are in-stent restenosis. * Other patients deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diameter stenosis (%) | 6 months (±30 days) | Percentage of target vessel stenosis per angiographic measurement at 6 months follow up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative Flow Ratio (QFR) | 9 months (±30 days) | 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. |
| Rate of restenosis | 9 months (±30 days) | Coronary angiography results showing a diameter stenosis of ≥50% are considered indicative of restenosis. |
| Late lumen loss (LLL) | 9 months (±30 days) | 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. |
| Target lesion revascularization (TLR) | 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days) | Including repeat PCI with stent implantation, balloon angioplasty, plaque atherectomy, or coronary artery bypass grafting (CABG) |
| Target vessel revascularization (TVR) | 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days) | Including repeat PCI with stent implantation, balloon angioplasty, plaque atherectomy, or CABG |
| Interventional success rate | Immediate post procedure (device and lesion success), and up to 7 days post-procedure (clinical success) | 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). |
| Thrombotic event rate | 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days) | Rate of thrombosis |
| Major adverse cardiac events (MACE) rate | 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days) | Including all-cause death, all myocardial infarctions, and all repeat revascularizations |
| Adverse events (AEs) and serious adverse events (SAEs) rate | 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days) | Rate of AEs or SAEs |
| Device defect rate | Immediate post procedure | Rate of device defect |
| Target lesion failure (TLF) rate | 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days) | Including cardiac death, target vessel-related myocardial infarction, and target lesion revascularization |
Countries
China
Contacts
Primary ContactYuying Bi
Outcome results
None listed