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:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT01084408
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years
* Clinical evidence of stable or unstable angina or a positive functional study
* Single, stenotic de novo lesion in a native coronary artery, type A or selected B1 (see 4.3.1.1 Definition of lesion types)
* Diameter stenosis \> 70% (visual estimate)
* Vessel diameter 2.5 - 3.5 mm
* Female patients can enter this study if they are post-menopausal for at least two years or have undergone hysterectomy or sterilization
* Signed patient informed consent form
* Patient's and treating physician's agree that the patient will return for all required post procedure follow-up assessments as defined in the clinical protocol
Exclusion Criteria:
* Left ventricular ejection fraction of \< 30%
* Visible thrombus proximal to the lesion
* Expection that treatment with devices other than PTCA will be required for this lesion.
* Stenosis is within a bypass graft
* Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, paclitaxel, or a sensitivity to contrast media which cannot be adequately pre-medicated
* Other medical illness (i.e. cancer, liver disease or congestive heart failure) that may require cytostatic or radiation therapy, cause the subject to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than two years).
* Acute myocardial infarction within the past 72 hours of the intended treatment (de-fined as: Q wave infarction having total creatinine kinase (CK) \>3 times the upper normal limit, or CK remains elevated above hospital normal at time of treatment)
* Chronic renal insufficiency with serum creatinine \> 2.0 mg%
* Significant gastrointestinal (GI) bleed within the past six months.
* History of bleeding diathesis or coagulopathy or will refuse blood transfusions
* Extensive peripheral vascular disease that precludes safe 6 French sheath insertion and / or requires additional anti-platelet and / or anti-coagulation treatment.
* Participating in another device or drug study within the last 6 months which may inter-fere with the interpretation of results of this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT01084408
Study Brief:
Protocol Section:
NCT01084408