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 @ 4:38 PM
Ignite Modification Date:
2025-12-24 @ 4:38 PM
NCT ID:
NCT03069066
Eligibility Criteria:
In-stent restenosis with ischemia. Signed Informed Consent IRB approval
INCLUSION CRITERIA:
PATIENT
* Age \> 20 and \< 85 years of age
* Acceptance of late angiographic evaluation
* Angina or objective evidence of ischemia
LESION
* ISR (\>50% diameter stenosis on visual assessment)
* Previous stent location known
EXCLUSION CRITERIA:
PATIENT
* Inclusion in other clinical research protocol
* Allergy to antiplatelet agents
* Women in childbearing age
* Severe associated systemic diseases (including renal or liver failure) or diseases affecting life expectancy
* Recent myocardial infarction
* Time from index stent implantation \< 1 month
* Anticipated difficulties for late angiographic evaluation
LESION
* Stent thrombosis or large thrombus within the stent
* Angiographic failure during initial stent implantation or persistence or large dissection.
* Severe tortuosity or calcification or major difficulties during previous stent implantation
* Vessel diameter \< 2.25 mm (visual assessment)
* Stenosis outside stent stent edge (edge ISR are eligible)
* Very diffuse ISR (\>30 mm in length)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
85 Years
Study:
NCT03069066
Study Brief:
Protocol Section:
NCT03069066