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

NCT ID: NCT06618248

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-20
• Study Completion Date: 2027-03-31

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.

Conditions

Coronary Bifurcation Lesion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sirolimus-coated spiral balloon (SuperFlow®)

A PTCA spiral balloon catheter with sirolimus coating (3ug/mm\^2) on balloon surface

Group Type: EXPERIMENTAL

Sirolimus coated balloon angioplasty

Intervention Type: 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.

Paclitaxel-coated balloon (Bingo™）

A PTCA balloon catheter with paclitaxel coating (3ug/mm\^2) on balloon surface

Group Type: ACTIVE_COMPARATOR

Paclitaxel coated balloon angioplasty

Intervention Type: 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.

Interventions

Sirolimus 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.

Intervention Type: COMBINATION_PRODUCT

Paclitaxel 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.

Intervention Type: COMBINATION_PRODUCT

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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: collaborator

Dongguan TT Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tim Wu, MD, PhD

Role: STUDY_CHAIR

Dongguan TT Medical

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yuying Bi

Role: CONTACT

ybi@ttmedicalinc.com

+86 22215363

Facility Contacts

Zheng Bo, MD

Role: primary

Other Identifiers

SCB-CTP-B-V1

Identifier Type: -

Identifier Source: org_study_id