Status:
COMPLETED
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)
Lead Sponsor:
Abbott Medical Devices
Conditions:
Coronary Occlusion
Thrombosis (Stent Thrombosis)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a prospective, randomized, active-controlled, open label, parallel two-arm, multi-center, post-approval study descriptively comparing the XIENCE V EECSS to the CYPHER SELECT PLUS Sirolimus-Elu...
Detailed Description
Objectives * Confirm the safety and effectiveness of the XIENCE V EECSS for the treatment of patients in China * Evaluate patient compliance with dual antiplatelet therapy (DAPT) * Evaluate physician...
Eligibility Criteria
Inclusion
- General Inclusion Criteria
- Patient must be at least 18 years of age
- 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.
- Patient must agree to undergo all protocol-required follow-ups until the completion of his/her 2-year follow-up.
- 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
- 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.
- Target lesion(s) must measure ≤ 28 mm in length by visual estimation.
- A maximum of two de novo lesions can be treated, ie,
- One lesion in one vessel, OR
- One lesion in each of two vessels, OR
- Two lesions in one vessel
Exclusion
- General Exclusion Criteria
- Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year post index procedure
- Patients with known renal insufficiency or failure (eg, serum creatinine level of \> 2.5 mg/dL, or patient is on dialysis)
- 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
- Non-study PCI for lesions in a target vessel (including side branches) has been performed within 1 year prior to the index procedure
- Patient has a planned PCI (staged procedure) within 6 months from the date of the index procedure
- Left ventricular ejection fraction (LVEF) of \< 30%.
- Any planned surgery necessitating discontinuation of antiplatelet therapy within 1 year
- Patient's current medical condition has a life expectancy of \< 2 years
- Patient meets contraindications of the IFU
- Angiographic Exclusion Criteria
- Lesion located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
- Lesion located in left main coronary artery
- Ostial lesion (within 3 mm of the aorta junction, or origin of the left anterior descending or left circumflex arteries)
- 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
- Total occluded lesions (TIMI=0)
- Restenotic lesions
- Thrombus-containing vessel
- Extreme angulation (≥ 90º) proximal to or within the lesion
- Excessive tortuosity proximal to or within the lesion
- Heavy calcification
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
546 Patients enrolled
Trial Details
Trial ID
NCT01178268
Start Date
August 1 2010
End Date
September 1 2014
Last Update
August 24 2016
Active Locations (2)
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1
Fu Wai Hospital
Beijing, China, 100037
2
Authorized Representative in China Guidant International Trading (Shanghai) Co., Ltd.
Shanghai, China, 200122