Actively Recruiting
Efficacy and Safety of Sirolimus-coated Coronary Balloon Dilatation Catheter for De Novo Coronary Bifurcation Lesions
Led by BrosMed Medical Co., Ltd · Updated on 2025-09-17
250
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
Sponsors
B
BrosMed Medical Co., Ltd
Lead Sponsor
L
LanZhou University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Evaluating the Safety and Efficacy of Sirolimus-coated Coronary Balloon Dilatation Catheter vs Paclitaxel-coated balloon catheter for the Treatment of De Novo Coronary Bifurcation Lesions
CONDITIONS
Official Title
Efficacy and Safety of Sirolimus-coated Coronary Balloon Dilatation Catheter for De Novo Coronary Bifurcation Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Evidence of asymptomatic myocardial ischemia, stable or unstable angina, or stable myocardial infarction occurring more than 7 days before enrollment
- Suitable for coronary revascularization including balloon angioplasty, stent implantation, or bypass surgery
- Ability to understand the trial purpose and willingness to participate and provide informed consent
- Maximum of 2 vessels requiring treatment with no more than 3 lesions total
- If non-target and target lesions are in the same vessel, the non-target lesion must be distal to the target lesion
- Successful treatment of non-target lesion prior to target lesion
- One true bifurcation lesion requiring treatment with at least 70% stenosis at the side branch ostium
- Successful pre-dilation or kissing balloon of the side branch lesion with no severe dissection and less than or equal to 30% residual stenosis and TIMI 3 flow
- Suitable for PCI with main branch lesion planned for stent implantation and side branch treated with drug-coated balloon without stent
- Reference diameter of the side branch lesion between 2.0 and 4.0 mm and lesion length up to 38 mm
You will not qualify if you...
- Unstable arrhythmias such as high-risk ventricular premature beats or ventricular tachycardia
- Severe heart failure classified as NYHA Class IV
- Preoperative renal impairment or current hemodialysis treatment
- Bleeding tendencies or contraindications to antiplatelet and anticoagulant therapy
- History of peptic ulcer or gastrointestinal bleeding within 6 months
- History of cerebral hemorrhage, infarction, or other stroke within 6 months
- Known allergies to contrast agents, Paclitaxel, Sirolimus, or their derivatives
- Life expectancy less than 12 months
- Poor compliance or inability to follow study requirements as judged by investigators
- Participation in other ongoing clinical trials without reaching their primary endpoints
- Pregnant or breastfeeding women or women planning to conceive within 12 months without effective contraception
- Left main trunk and its bifurcation lesions requiring treatment
- Thrombus in the target lesion or excessive vessel tortuosity preventing balloon passage
- Total occlusion in the side branch lesion of the target lesion
- Severe calcification in the side branch lesion preventing pre-dilation or kissing balloon treatment
- In-stent restenosis in target vessel main or side branches
- Residual stenosis greater than 30% or dissection grade C or higher after pre-dilation or kissing balloon treatment of the side branch lesion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
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