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 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT01151033
Eligibility Criteria:
General Inclusion Criteria:
* Patient must be at least 18 years of age.
* Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the ProNOVA XR DES and she or her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site.
* Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia)
* Patient must agree to undergo all required follow-up examinations.
* Patients of childbearing potential must have had a negative pregnancy test within 7 days before treatment, and must not be nursing at the time of treatment.
Angiographic Inclusion Criteria:
* Target lesions must be de novo lesions (no prior stent implant, no prior brachytherapy)
* Target vessel reference diameter must be between 2.25 mm and 4.0 mm by visual estimate
* Target lesion ≤ 28 mm in length by visual estimate
Exclusion Criteria:
* Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year)
* Patient has a known hypersensitivity or contraindication to aspirin, either heparin or bivalirudin, both clopidogrel and ticlopidine, cobalt, chromium, nickel, or contrast sensitivity that cannot be adequately pre-medicated
* Participation in another device or drug study or has completed the follow-up phase of another study within the last 30 days
* Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01151033
Study Brief:
Protocol Section:
NCT01151033