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Tests treatment safety and results for Coronary Arterial Disease (CAD)
Official title Efficacy and Safety of Sirolimus-coated Coronary Balloon Dilatation Catheter for De Novo Coronary Bifurcation Lesions
ClinicalTrials.gov ID: NCT06822712
What this study is testing
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Participants in this clinical trial must meet all of the following criteria: General 1. Age ≥18 years and ≤80 years.
- Evidence of asymptomatic myocardial ischemia, or stable/unstable angina, or myocardial infarction that occurred more than 7 days before enrollment...
- Suitable for any type of coronary artery revascularization, such as balloon angioplasty, stent implantation, and coronary artery bypass grafting...
- Capable of understanding the purpose of the trial, willing to participate, and acknowledging the risks and benefits described in the informed consent...
- If the non-target lesion and the target lesion are in the same vessel, the non-target lesion must be located distal to the target lesion.
You likely can't join if
- If a participant has any of the following conditions, they will be excluded from the study: General Exclusion Criteria
- Unstable Arrhythmias: Such as high-risk ventricular premature beats or ventricular tachycardia.
- Severe Heart Failure (New York Heart Association Functional Classification, NYHA Class IV).
- Preoperative Renal Impairment: Or currently undergoing hemodialysis treatment.
- Bleeding Tendencies or Contraindications to Antiplatelet Agents and Anticoagulants: Participants who cannot undergo antithrombotic therapy.
- History of Peptic Ulcer or Gastrointestinal Bleeding within the Past 6 Months: Or history of cerebral hemorrhage, cerebral infarction, or other...
See the full eligibility criteria
Who can join
- Participants in this clinical trial must meet all of the following criteria: General 1. Age ≥18 years and ≤80 years.
- Evidence of asymptomatic myocardial ischemia, or stable/unstable angina, or myocardial infarction that occurred more than 7 days before enrollment and is now stable.
- Suitable for any type of coronary artery revascularization, such as balloon angioplasty, stent implantation, and coronary artery bypass grafting (CABG).
- Capable of understanding the purpose of the trial, willing to participate, and acknowledging the risks and benefits described in the informed consent document by signing the informed consent form, and willing to undergo...
- If the non-target lesion and the target lesion are in the same vessel, the non-target lesion must be located distal to the target lesion.
- Successful treatment treatment of the non-target lesion prior to the target lesion.
- Only one true bifurcation lesion requiring treatment (Medina classification 1.1.1, 1.0.1, 0.1.1), with a diameter stenosis ≥70% (by visual estimation) at the ostium of the target lesion side branch.
- Successful pre-dilation/kissing balloon of the target lesion side branch, no dissection grade C or higher, residual stenosis ≤30% (by visual estimation) in the side branch lesion, and TIMI 3 flow.
- Suitable for PCI, with the main branch lesion of the target lesion planned for stent implantation without drug-coated balloon treatment, and the side branch lesion treated with a drug-coated balloon without stent...
- Reference diameter of the target lesion side branch 2.0-4.0 mm, and lesion length ≤38 mm.
What rules you out
- If a participant has any of the following conditions, they will be excluded from the study: General Exclusion Criteria
- Unstable Arrhythmias: Such as high-risk ventricular premature beats or ventricular tachycardia.
- Severe Heart Failure (New York Heart Association Functional Classification, NYHA Class IV).
- Preoperative Renal Impairment: Or currently undergoing hemodialysis treatment.
- Bleeding Tendencies or Contraindications to Antiplatelet Agents and Anticoagulants: Participants who cannot undergo antithrombotic therapy.
- History of Peptic Ulcer or Gastrointestinal Bleeding within the Past 6 Months: Or history of cerebral hemorrhage, cerebral infarction, or other cerebrovascular accidents (stroke) within the past 6 months.
- Known Allergies to Contrast Agents, Paclitaxel, Sirolimus, or Their Derivatives.
- Life Expectancy Less Than 12 Months.
- Poor Compliance: Participants who, in the investigator's judgment, are unlikely to adhere to the study requirements or are otherwise deemed unsuitable for inclusion.
- Participation in Other Ongoing Clinical Trials: Participants who have not reached the primary endpoint in other ongoing clinical trials.
- Pregnant or Lactating Women: Women who plan to conceive within 12 months or are unwilling to use effective contraception. Angiographic Exclusion Criteria
- Left Main Trunk and Its Bifurcation Lesions Requiring Treatment.
- Thrombus in the Target Lesion: Excessive tortuosity of the vessel, making it unlikely for the balloon to pass through the lesion.
- Total Occlusion in the Side Branch Lesion of the Target Lesion.
- Severe Calcification in the Side Branch Lesion of the Target Lesion: Lesions that cannot be pre-dilated or treated with double-balloon kissing dilation.
- In-Stent Restenosis in the Target Vessel (Including Both Main and Side Branches).
- Residual Stenosis \>30% (by Visual Estimation) or Dissection Grade C or Higher After Pre-Dilation or Double-Balloon Kissing Dilation of the Side Branch Lesion of the Target Lesion.
The study team makes the final eligibility decision.
Where it's taking place
- Lanzhou, Gansu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lanzhou, Gansu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.