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

Dongguan TT Medical0 sites280 target enrollmentDecember 20, 2023

ConditionsCoronary Bifurcation Lesion

Overview

Phase: N/A
Intervention: Not specified
Conditions: Coronary Bifurcation Lesion
Sponsor: Dongguan TT Medical
Enrollment: 280
Primary Endpoint: Diameter stenosis (%)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 20, 2023

End Date

March 2027

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Dongguan TT Medical

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Diameter stenosis (%)

Time Frame: 6 months (±30 days)

Percentage of target vessel stenosis per angiographic measurement at 6 months follow up

Secondary Outcomes

Interventional success rate(Immediate post procedure (device and lesion success), and up to 7 days post-procedure (clinical success))
Quantitative Flow Ratio (QFR)(9 months (±30 days))
Rate of restenosis(9 months (±30 days))
Late lumen loss (LLL)(9 months (±30 days))
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))
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))
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))
Thrombotic event rate(1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days))
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))
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))
Device defect rate(Immediate post procedure)