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:
NCT01555658
Eligibility Criteria:
Inclusion Criteria:Clinical Inclusion Criteria
Candidates for this study must meet all of the following criteria:
* Male or female able to understand and sign a witnessed informed consent
* Age ≥ 18 yo
* Patients with stable (CCS 1-4) or unstable angina pectoris (but with the most recent anginal episode occurring \>48 hours before the index procedure) or documented silent ischemia
* Ongoing or recent episode (\<48 hours) of unstable coronary artery disease (including non-ST-elevation acute coronary syndromes)
* Stable Hemodynamic conditions (systolic BP \> 100 HR \> 40 \< 100).
* No clinical and ECG changes suggestive of ongoing acute or recent (\<48 hours) myocardial infarction.
Angiographic inclusion criteria
* Angiographic evidence of a de novo lesion \> 50% requiring implantation of two stents in overlapping with a total stent length\> 33 mm and reference vessel diameter between 2.5 and 4.0 mm (by visual estimation) in one coronary vessel. Multiple lesions in the same vessels can be included but at least one lesion should require implantation of two stents in overlapping with a total stent length \> 33 mm. The definition of multivessel disease requires an intention to treat at least two lesions (with a least one with the characteristics reported above) in two different major epicardial segments. For example, the presence of a lesion in the left anterior descending artery and in the obtuse marginal or the presence of a lesions in the right postero-lateral branch and in a diagonal branch will qualify as multivessel. The presence of lesions in the left anterior descending artery and in the diagonal branch will not qualify as multivessel. Bifurcation lesions and ostial lesions can be included, but only if at least two stent in overlapping with a total stent length \> 33 mm are implanted in the same branch. When treating diffuse lesion in the same vessel, overlapping stenting is recommended with high pressure (\>14 atm post-dilation) of the overlap zone. There is no maximum stent length to treat one coronary vessel.
Exclusion Criteria:
* Clinical Exclusion criteria
* Female sex with childbearing potential
* Age \<18 years
* Serum creatinine\>2.5 mg/dl or with a creatinine clearance \<40mL/min
* Ongoing serious bleeding or bleeding diathesis
* Previous stroke in the last 6 months
* Major surgery within the previous 6 weeks
* Platelet count \<100,000 per mm3
* Ejection Fraction below 30%
* STEMIpatients' treated with primary-PCI, or rescue-PCI or facilitated-PCI or thrombolysis therapy.
* Patients treated with Glycoprotein IIb/IIIa inhibitor for ACS
* The patient has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, or sensitivity to contrast which cannot be adequately pre-medicated.
* Hemodynamic instability (systolic blood pressure \< 100 mm Hg; heart rate \< 40 bpm or \>100 bpm; complex ventricular arrhythmias; AV block) requiring balloon counterpulsation or inotropic support.
* The patient is simultaneously participating in another device or drug study. Patient must have completed the follow-up phase of any previous study at least 30 days prior to enrolment in this study.
* Positive clinical history for intracranial neoplasia, AV malformation, aneurysm.
* INR ≥ 2.0 or prothrombin time 1.2 times upper limit of normality
* Clinically manifested reduced liver function
* Programmed surgery within six months
Angiographic exclusion criteria
* Vessel size \< 2.25 mm or \> 5 mm (by visual estimation).
* Previous implantation of a bare-metal or drug-eluting stent in the target lesion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01555658
Study Brief:
Protocol Section:
NCT01555658