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:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-24 @ 12:37 PM
NCT ID:
NCT05342961
Eligibility Criteria:
Inclusion Criteria:
* 1\. 18-75 years
* 2.Stable or unstable angina, or previous myocardial infarction, or Asymptomatic ischemia judged by clinician ,Target vascular diameter: 2.00-4.00mm ,Coronary artery stenosis stenosis ≥ 70% by visual inspection, or ≥ 50% with evidence of ischemia, TIMI blood flow≥ 1,the operator judge that the patient needs spinous balloon to treat.
* 3\. Paticipant can understand the study ,voluntarily participate in and sign the informed consent form,and accept scheduled follow-up.
Exclusion Criteria:
Patient related:
* 1.Pregnant and breast-feeding women or intention to be pregnant.
* 2.Subjects with MI within one week, or more than one week after the onset of MI,but TNI or TNT have not returned to normal.
* 3.The spinous balloon failed to pass through the stenosis after small balloon dilation , and the lesion need to be rotary grinded.
* 4\. Non-target vessel did not be dealed with successful before dealing with target vessel, or non-target vascular lesion number is more than three.
* 5.Serious heart failure（NYHA IV）
* 6.Severe renal failure（Cr\>443uMol/L) or patients undergoing hemodialysis.
* 7.Patient with heart transplant.
* 8.Patient with CABG.
* 9.Patients with hemodynamic instability or shock symptoms.
* 10.Life expectancy less than one year.
* 11.Expected to undergo surgery within one month.
* 12.Patients with bleeding tendency, history of active gastrointestinal ulcer, contraindications of antiplatelet or anticoagulant treatment, cannot receive anticoagulant treatment, and patients have hemorrhagic stroke within six months.
* 13.Allergy to heparin and contrast agent.
* 14.The illness of the patient make the treatment and evaluation difficult.
* 15.Those who have participated in other drug or medical device trials have not reached main research endpoint.
* 16.Clinicians estimated that the risk of intervention is very high or the patient should be excluded for other reasons.
* 17.Poor of compliance
Lesion related:
* 18.Lesions of LAD or with a distance of ≤ 2mm beyond LAD.
* 19.Angiogram showed thrombus.
* 20.CTO,and TIMI blood flow=0,
* 21.Coronary artery spasm
* 22.Lesions of LAD without bypass surgery or collateral circulation protection.
* 23.The doctor considered the patient unfit for the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05342961
Study Brief:
Protocol Section:
NCT05342961