XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)
Condition: Coronary Occlusion; Thrombosis (Stent Thrombosis); Vascular Disease; Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Thrombosis; Vascular Diseases; Coronary Stenosis; Coronary Occlusion; Coronary Restenosis; Ischemia
Intervention: XIENCE V EECSS; CYPHER SELECT PLUS SECSS
Intervention description: Patients who will receive this stent.; Patients who will receive this stent.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 546.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug eluting stents; Stents; Angioplasty

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-Eluting Coronary Stent System (SECSS) ("CYPHER SELECT PLUS") during
      commercial use in China.
    

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