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| Protocol Number: |
05-368 |
| Trial Phase: |
IDE |
| Maximum # of Subjects: |
1125 |
| IRB Number: |
1078790 - WIRB |
| Study Status: |
Active |
| Enrollment Status: |
Open |
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| To evaluate the safety and efficacy of the XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V) for the treatment of up to three de novo native coronary artery lesions, maximum of two lesions per epicardial vessel. |
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Eligibility |
Inclusion Criteria: 1. Target lesion (s) must be located in a native coronary artery with visually estimated diameter of greater than or equal to 2.5 mm to less than or equal to 4.25 mm; treatment of up to three de novo target lesions, maximum of two de novo target lesions per epicardial vessel.
2. Target lesion (s) must measureless than or equal to 28 mm in length by visual estimation.
3. If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria.
4. The target lesion (s) must be in a major artery or branch with a visually estimated stenosis of greater than or equal to 50% and less than 100% with a TIMI flow greater than or equal to 1.
5. Non-study, percutaneous intervention for lesions in a target vessel (including side branches) is allowed if done > or equal to 9 months prior to the index procedure.
6. Non-study percutaneous intervention for lesions in a non-target vessel including:
- Successful and uncomplicated (visually estimated diameter stenosis < 50%, TIMI Grade-3 flow, no ECG changes, prolonged chest pain, or angiographic complications) bare-metal stent, balloon dilatation, cutting balloon, arherectomy, thrombectomy, and laser treatments are allowed if done> or equal to 24 hours prior to the index procedure or during (before randomization) the index procedure. For interventions done within the 24 to 48 hours prior to the index procedure, CK and CK-MB must be assessed to be < 2 times the upper limit of normal at the time of the index procedure. NOTE: Procedures within the 24 hour period preceding the index procedure are not permitted.
- Unsuccessful or complicated bare-metal stent, balloon dilatation, cutting balloon, atherectomy, thrombectomy, and laser treatments are allowed if done > or equal to 30 days prior to the index procedure.
- Drug-eluting stent treatment is allowed if done . or equal to 90 days prior to the index procedure.
7. Non-study, percutaneous interventions for lesion (s) in a target vessel (including side branches) or non-target vessel are allowed if done > or equal to 9 months after the index procedure. |
Exclusion Criteria: 1. The target lesion (s) meets any of the following criteria:
- Left main coronary artery location including left main ostial location (NOTE: RCA-aorto-ostial lesions are not excluded).
- Located within 2 mm of the origin of the LAD or LCX.
- Located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and any visually estimated diameter stenosis > 20%) arterial or saphenous vein graft.
- Involves a bifurcation in which the side branch is > or equal to 2 mm in diameter AND the ostium of the side branch is > 50% stenosed by visual estimation.
- Involves a side branch requiring pre-dilatation.
- Total occlusion (TIMI flow 0) prior to wire crossing.
- Excessive tortuosity proximal to or within in the lesion.
- Extreme angulation (> or equal to 90) proximal to or within the lesion.
- Heavy calcification.
- Restenotic from previous intervention.
2. Subject has received brachytherapy in any epicardial vessel (including side branches).
3. The target vessel contains thrombus.
4. Another clinically significant lesion in the target vessel is present that requires or has a high probability of requiring PCI during the index procedure.
5. Another lesion in a target or non-target vessel (including all side branches) is present that requires or has a high probability of requiring PCI within 9 months after the index procedure. |
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