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 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT05451368
Eligibility Criteria:
Inclusion Criteria:
1. The patient is older than 18 years.
2. The patient had undergone coronary angiography at our hospital for PCI and had first ISR with drug-eluting stent implantation.
3. Calcified lesion greater than 5 mm in length.
4. Stent implantation time greater than 30 days.
Exclusion Criteria:
1. Bridge vessel lesions following coronary artery bypass grafting.
2. Planned modification of the DAPT regimen for medical reasons or other surgical procedures requiring modification within 3 months of the index procedure.
3. Patients undergoing heart transplantation.
4. Significant angiogenic lesions in the target vessel that may prevent stent delivery and deployment.
5. Bifurcation disease lesions involving collateral branches ≥ 2.5 mm in diameter.
6. Lesions deemed by the investigator to be unsuitable for OCT imaging (e.g., extremely curved, very distal lesions).
7. Serum creatinine \> 2.0 mg/dl at the time of treatment.
8. Greater than three types of stent implantation.
9. Subjects with malignancy or other co-morbidities (i.e., severe liver, kidney, lung, or pancreatic disease with a life expectancy of less than 18 months or which may result in protocol non-compliance).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05451368
Study Brief:
Protocol Section:
NCT05451368