Coronary Bifurcation LesionNCT06618248
Efficacy and Safety of Sirolimus-Coated Spiral Balloon for Coronary Bifurcation Lesions
A study testing Sirolimus coated balloon angioplasty and Paclitaxel coated balloon angioplasty in people with Coronary Bifurcation Lesion, run by Dongguan TT Medical at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Bifurcation Lesion
- What is being tested?
- Sirolimus coated balloon angioplasty and Paclitaxel coated balloon angioplasty
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2023to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Zheng Bo, MD
About this study
Official title: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Trial to Evaluate the Efficacy and Safety of the Sirolimus-coated Spiral Balloon Catheter for the Treatment of Coronary Bifurcation Lesions
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.
Read the 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.
- Conditions
- Coronary Bifurcation Lesion
- Being tested
- Sirolimus coated balloon angioplasty, Paclitaxel coated balloon angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirolimus coated balloon angioplastyCombination 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.
Paclitaxel coated balloon angioplastyCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Sirolimus-coated spiral balloon (SuperFlow®) | Experimental | A PTCA spiral balloon catheter with sirolimus coating (3ug/mm^2) on balloon surface Receives: Combination Product: Sirolimus coated balloon angioplasty |
| Paclitaxel-coated balloon (Bingo™） | Active comparator | A PTCA balloon catheter with paclitaxel coating (3ug/mm^2) on balloon surface Receives: Combination Product: Paclitaxel coated balloon angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diameter stenosis (%)
Percentage of target vessel stenosis per angiographic measurement at 6 months follow up
Measured: 6 months (±30 days)
Secondary outcomes (11)
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).
Measured: 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.
Measured: 9 months (±30 days)
Rate of restenosis
Coronary angiography results showing a diameter stenosis of ≥50% are considered indicative of restenosis.
Measured: 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.
Measured: 9 months (±30 days)
Target lesion revascularization (TLR)
Including repeat PCI with stent implantation, balloon angioplasty, plaque atherectomy, or coronary artery bypass grafting (CABG)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Immediate post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start20 Dec 2023
- Primary completionSep 2025 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Bifurcation LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongguan TT Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University First Hospital
- Responsible party
- Sponsor
- Investigators
- Tim Wu, MD, PhD, Study chair, Dongguan TT Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618248
- Sponsor's protocol ID
- SCB-CTP-B-V1
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Trial to Evaluate the Efficacy and Safety of the Sirolimus-coated Spiral Balloon Catheter for the Treatment of Coronary Bifurcation Lesions
- ClinicalTrials.gov ID
- NCT06618248
- Acronym / sponsor ID
- SCB-CTP-B-V1
- Conditions
- Coronary Bifurcation Lesion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Dongguan TT MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Peking University First Hospital
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sirolimus-coated spiral balloon (SuperFlow®) | Experimental | Combination Product: Sirolimus coated balloon angioplastyA PTCA spiral balloon catheter with sirolimus coating (3ug/mm^2) on balloon surface |
| Paclitaxel-coated balloon (Bingo™） | Active comparator | Combination Product: Paclitaxel coated balloon angioplastyA PTCA balloon catheter with paclitaxel coating (3ug/mm^2) on balloon surface |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sirolimus coated balloon angioplastyThis 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 product | Sirolimus-coated spiral balloon (SuperFlow®) |
| Paclitaxel coated balloon angioplastyThis 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. | Combination product | Paclitaxel-coated balloon (Bingo™） |
Primary outcome
Diameter stenosis (%)
Time frame: 6 months (±30 days)
Percentage of target vessel stenosis per angiographic measurement at 6 months follow up
11 secondary outcomes
Interventional success rate
Time frame: Immediate post procedure (device and lesion success), and up to 7 days post-procedure (clinical success)
Quantitative Flow Ratio (QFR)
Time frame: 9 months (±30 days)
Rate of restenosis
Time frame: 9 months (±30 days)
Late lumen loss (LLL)
Time frame: 9 months (±30 days)
Target lesion revascularization (TLR)
Time frame: 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)
Time frame: 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
Time frame: 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days)
Thrombotic event rate
Time frame: 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days)
Major adverse cardiac events (MACE) rate
Time frame: 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
Time frame: 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days)
Device defect rate
Time frame: Immediate post procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tim Wu, MD, PhD study chair
Dongguan TT Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sirolimus coated balloon angioplasty and Paclitaxel coated balloon angioplasty in people with Coronary Bifurcation Lesion, run by Dongguan TT Medical at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuying Bi (+86 22215363, ybi@ttmedicalinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diameter stenosis (%) (time frame: 6 months (±30 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.