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 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT01178268
Eligibility Criteria:
Inclusion Criteria:
* General Inclusion Criteria
1. Patient must be at least 18 years of age
2. The patient or patient's legally-authorized representative agrees to participate in this study by signing the Ethics Committee (EC)-approved ICF prior to procedure.
3. Patient must agree to undergo all protocol-required follow-ups until the completion of his/her 2-year follow-up.
4. Patient must not currently be and must agree not to become a participant in any other clinical trial until completion of his/her 2-year follow-up.
Angiographic Inclusion Criteria
1. Target lesion(s) must be located in a native de novo coronary artery with a visually estimated diameter between ≥ 2.25 and ≤ 4.0 mm.
2. Target lesion(s) must measure ≤ 28 mm in length by visual estimation.
3. A maximum of two de novo lesions can be treated, ie,
1. One lesion in one vessel, OR
2. One lesion in each of two vessels, OR
3. Two lesions in one vessel
Exclusion Criteria:
* General Exclusion Criteria
1. Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year post index procedure
2. Patients with known renal insufficiency or failure (eg, serum creatinine level of \> 2.5 mg/dL, or patient is on dialysis)
3. Patient had an MI within 72 hours and creatine kinase-myocardial band isoenzyme (CK-MB) has not returned to the normal range at the index procedure
4. Non-study PCI for lesions in a target vessel (including side branches) has been performed within 1 year prior to the index procedure
5. Patient has a planned PCI (staged procedure) within 6 months from the date of the index procedure
6. Left ventricular ejection fraction (LVEF) of \< 30%.
7. Any planned surgery necessitating discontinuation of antiplatelet therapy within 1 year
8. Patient's current medical condition has a life expectancy of \< 2 years
9. Patient meets contraindications of the IFU
Angiographic Exclusion Criteria
1. Lesion located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
2. Lesion located in left main coronary artery
3. Ostial lesion (within 3 mm of the aorta junction, or origin of the left anterior descending or left circumflex arteries)
4. Involves a bifurcation in which the side branch is ≥ 2 mm in diameter AND the ostium of the side branch is \> 50% stenosed by visual estimation
5. Total occluded lesions (TIMI=0)
6. Restenotic lesions
7. Thrombus-containing vessel
8. Extreme angulation (≥ 90º) proximal to or within the lesion
9. Excessive tortuosity proximal to or within the lesion
10. Heavy calcification
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01178268
Study Brief:
Protocol Section:
NCT01178268