RecruitingNCT06618248Updated Oct 1, 2024

Efficacy and Safety of Sirolimus-Coated Spiral Balloon for Coronary Bifurcation Lesions

An interventional study of Sirolimus coated balloon angioplasty and Paclitaxel coated balloon angioplasty in Coronary Bifurcation Lesion, sponsored by Dongguan TT Medical. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-10-01.

Sponsored by Dongguan TT Medical · Not applicable, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
Registered 9 months after the study started (first participant enrolled Dec 2023, registered Sep 2024).
Started Dec 2023; still recruiting 2 years 9 months later.

Phase: Not applicable
Study type: Interventional
Enrollment: 280
Allocation: Randomized
Ages: 18 Years to 85 Years
Sex: All

Study 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 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 studied

Coronary Bifurcation Lesion

In context

Lead sponsor

This is the only study on the registry with Dongguan TT Medical as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts 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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 280 participants (estimated)

Study arms

Experimental
Sirolimus-coated spiral balloon (SuperFlow®)
A PTCA spiral balloon catheter with sirolimus coating (3ug/mm\^2) on balloon surface
Combination Product: Sirolimus coated balloon angioplasty
Active comparator
Paclitaxel-coated balloon (Bingo™）
A PTCA balloon catheter with paclitaxel coating (3ug/mm\^2) on balloon surface
Combination Product: Paclitaxel coated balloon angioplasty

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.

What researchers measure

Primary outcomes

Diameter stenosis (%)
Percentage of target vessel stenosis per angiographic measurement at 6 months follow up
Time frame: 6 months (±30 days)

Secondary outcomes

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).
Time frame: 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.
Time frame: 9 months (±30 days)
Rate of restenosis
Coronary angiography results showing a diameter stenosis of ≥50% are considered indicative of restenosis.
Time frame: 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.
Time frame: 9 months (±30 days)
Target lesion revascularization (TLR)
Including repeat PCI with stent implantation, balloon angioplasty, plaque atherectomy, or coronary artery bypass grafting (CABG)
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)
Including repeat PCI with stent implantation, balloon angioplasty, plaque atherectomy, or CABG
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
Including cardiac death, target vessel-related myocardial infarction, and target lesion revascularization
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
Rate of thrombosis
Time frame: 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
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
Rate of AEs or SAEs
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
Rate of device defect
Time frame: Immediate post procedure

Study locations

1 of 1 sites recruiting

Peking University First Hospital
Beijing, Beijing 100034, China
- Zheng Bo, MD · Contact
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06618248
Lead sponsor: Dongguan TT Medical
Collaborators: Peking University First Hospital
Responsible party: Sponsor
First posted: Oct 1, 2024
Start date: Dec 20, 2023
Primary completion: Sep 2025 (estimated)
Completion: Mar 2027 (estimated)
Last update: Oct 1, 2024

Study contacts

Yuying Bi

Contact

ybi@ttmedicalinc.com

+86 22215363

Tim Wu, MD, PhD

study chair · Dongguan TT Medical

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion