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 @ 11:00 PM
Ignite Modification Date:
2025-12-24 @ 11:00 PM
NCT ID:
NCT00936169
Eligibility Criteria:
Inclusion Criteria:
* A complex lesion is regarded as a lesion where the operator would expect a lower immediate and long term success rate compared to non-complex lesions (according to the results of Randomized Controlled Trials and from large Registries). The operator must consider the implantation of a drug-eluting stent, feasible and appropriate for this particular complex lesion
Exclusion Criteria:
* Contra-indication to dual anti-platelet therapy.
* Ejection fraction \<30%.
* Renal failure (creatinine \>2 mg/dL).
* Significant co-morbidity precluding clinical follow-up.
* Acute myocardial infarction in the 48 hours prior to the procedure.
* In-stent restenosis
* Prior brachytherapy
* Thrombocytopenia \<100,000
* Unprotected left main stem stenosis
* Venous or arterial grafts
* Recipient of heart transplant
* A positive pregnancy test in women with child bearing potential
* Acute infections
* Major surgery planned which will lead to discontinuation of antiplatelet therapy
* Patients with prior BMS or DES implanted in the target vessel less than one year prior to the enrollment, including one year from any intercurrent restenotic or thrombotic event
* Age under 18 years old.
* There is no maximum number of lesions which can be treated
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00936169
Study Brief:
Protocol Section:
NCT00936169