Actively Recruiting
Efficacy and Safety of Sirolimus-Coated Spiral Balloon for Coronary Bifurcation Lesions
Led by Dongguan TT Medical · Updated on 2024-10-01
280
Participants Needed
1
Research Sites
166 weeks
Total Duration
On this page
Sponsors
D
Dongguan TT Medical
Lead Sponsor
P
Peking University First Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Sirolimus-Coated Spiral Balloon for Coronary Bifurcation Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 drug-coated balloon used on the branch.
- 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 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.
You will not qualify if you...
- Patients with bleeding disorders or active gastrointestinal ulcers.
- Patients who have had a stroke within the past 6 months.
- Patients 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
Research Team
Y
Yuying Bi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here