Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2025-12-25 @ 2:56 AM
NCT ID:
NCT05550233
Eligibility Criteria:
Inclusion Criteria:
* Over 18 years old;
* Asymptomatic myocardial ischemia, stable or unstable angina;
* The subject (or legal guardian) understands the trial requirements and treatment process, and signs a written informed consent before performing any prescribed inspection or operation;
* Willing to undergo all follow-up evaluations requested by the trial, including admission angiographic evaluation at 12 months;
* The target lesion must be the de novo lesion, and the diameter of the reference vessel is ≥3.0mm.
Exclusion Criteria:
* Patients with acute ST-segment elevation myocardial infarction/non-ST-segment elevation myocardial infarction within 3 months;
* Hypersensitivity to the investigational balloon/stent system or concomitant medications required by the protocol;
* Intolerant of dual antiplatelet therapy, or clinical conditions requiring long-term use of oral anticoagulants;
* Life expectancy is less than 12 months;
* eGFR≤30ml/min/1.73m2 or blood purification treatment;
* LVEF≤40% or NYHA cardiac function class≥III;
* Clinical conditions of severe hepatic insufficiency and coagulation disorder
* Pregnant or breastfeeding women;
* Participating in another clinical trial and have not completed the primary endpoint observation of the trial;
* Reference lumen diameter \> 4.0mm;
* Branch vessels ≥ 2.0 mm in diameter that may require intervention in the target lesion;
* The vessel where the target lesion is located has an independent lesion with a diameter stenosis of ≥50% and requires interventional therapy;
* Chronic total occlusive disease;
* Left main stem disease;
* Severe calcification, tortuous blood vessels, existing dissection or severe thrombus burden, the investigator judges that DCB is not suitable for treatment of lesions;
* Lesions with failed preprocessing, or lesions whose length exceeds the length of a single DES/DCB need to be covered after preprocessing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05550233
Study Brief:
Protocol Section:
NCT05550233