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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT01127958
Eligibility Criteria:
Inclusion Criteria:
* Restenosis of the initially stented main vessel, including ostial, left main and bifurcation lesions as well as venous or arterial grafts
* Restenosis of any type of stent; all drug-eluting stents or bare metal stents
* Restenosis must be present \> 50% in-stent and \< 5 mm out of the stent
* A reference diameter of ≥ 2.0 to 4.0 millimeters by visual estimation
* Amendable to PCI treatment with either the SeQuent ® Please DEB or the Xience™ Prime DES
* Amendable to dual antiplatelet treatment for the duration of 1 year
* Patients must be ≥ 18 years of age
* Patients must be able to understand the aim of the study, including risks, benefits and treatment alternatives
* Patients must agree to undergo a follow-up angiogram at 6 months (± 1 month)
* Patients must agree to undergo a clinical follow-up at 30 days, 6 months, 1, 2, 3, 4, and 5 years
Exclusion Criteria:
* The impossibility to arrange a follow-up coronary angiography at 6 months (± 1 month) after baseline procedure is considered an exclusion criterion for this study
* Patients have to meet the inclusion criteria;
* Life expectancy less than one year
* Severe renal insufficiency (glomerular filtration rate \<30mL/min), with exception of of patients with renal dialysis
* STEMI
* Restenosis in a biodegradable stent
* Restenosis in a non CE marked stent
* Requirement for PCI in the same vessel or expected in the next 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01127958
Study Brief:
Protocol Section:
NCT01127958