Phase 4
Completed N=488
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)
Coronary Occlusion · Thrombosis (Stent Thrombosis) · Vascular Disease · myocardial ischemia
Source: ClinicalTrials.gov NCT01178268 ↗
Enrolled (actual)
488
Serious AEs
16.0%
Results posted
Aug 2016
Primary outcomePrimary: In-stent Late Loss (LL) — 0.19; 0.21 Millimeter
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY In-stent Late Loss (LL) |
0.19; 0.21 | — |
| PRIMARY Ischemia-driven Target Vessel Failure (ID-TVF) |
4.7; 7.4 | — |
| PRIMARY Incidence of Composite of ST (Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave) |
1.6; 1.7 | — |
| SECONDARY Ischemia-driven Target Vessel Failure (ID-TVF) |
4.7; 7.4 | — |
| SECONDARY Ischemia-driven Target Vessel Failure (ID-TVF) |
4.7; 7.4 | — |
| SECONDARY Ischemia-driven Target Vessel Failure (ID-TVF) |
4.7; 7.4 | — |
| SECONDARY Ischemia-driven Target Vessel Failure (ID-TVF) |
4.7; 7.4 | — |
| SECONDARY Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave). |
1.1; 0.8 | — |
| SECONDARY Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave). |
1.1; 0.8 | — |
| SECONDARY Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave) |
1.9; 1.7 | — |
| SECONDARY Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave) |
1.9; 1.7 | — |
| SECONDARY Ischemia-driven Target Lesion Revascularization (ID-TLR) (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]) |
1.9; 3.3 | — |
| SECONDARY Ischemia-driven Target Lesion Failure (ID-TLF) |
3.9; 5.0 | — |
| SECONDARY Ischemia-driven Target Lesion Failure (ID-TLF) |
3.9; 5.0 | — |
| SECONDARY Ischemia-driven Target Lesion Failure (ID-TLF) |
3.9; 5.0 | — |
| SECONDARY Ischemia-driven Target Lesion Failure (ID-TLF) |
3.9; 5.0 | — |
| SECONDARY Ischemia-driven Target Lesion Failure (ID-TLF) |
3.9; 5.0 | — |
| SECONDARY Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV) |
1.7; 1.7 | — |
| SECONDARY Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV) |
1.7; 1.7 | — |
| SECONDARY Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV) |
1.7; 1.7 | — |
| SECONDARY Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV) |
1.7; 1.7 | — |
| SECONDARY Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV) |
1.7; 1.7 | — |
| SECONDARY All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) |
8.5; 11.6 | — |
| SECONDARY All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) |
8.5; 11.6 | — |
| SECONDARY All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) |
8.5; 11.6 | — |
| SECONDARY All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) |
8.5; 11.6 | — |
| SECONDARY All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG) |
8.5; 11.6 | — |
| SECONDARY Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI |
1.9; 1.7 | — |
| SECONDARY Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI |
1.9; 1.7 | — |
| SECONDARY Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI |
1.9; 1.7 | — |
| SECONDARY Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI |
1.9; 1.7 | — |
| SECONDARY Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI |
1.9; 1.7 | — |
| SECONDARY Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) |
3.9; 5.0 | — |
| SECONDARY Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) |
3.9; 5.0 | — |
| SECONDARY Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) |
3.9; 5.0 | — |
| SECONDARY Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) |
3.9; 5.0 | — |
| SECONDARY Major Adverse Cardiac Event (Cardiac Death, All MI and TLR) |
3.9; 5.0 | — |
| SECONDARY All Revascularization (TLR, TVR, and Non-TVR) |
6.6; 9.9 | — |
| SECONDARY All Revascularization (TLR, TVR, and Non-TVR) |
6.6; 9.9 | — |
| SECONDARY All Revascularization (TLR, TVR, and Non-TVR) |
6.6; 9.9 | — |
| SECONDARY All Revascularization (TLR, TVR, and Non-TVR) |
6.6; 9.9 | — |
| SECONDARY All Revascularization (TLR, TVR, and Non-TVR) |
6.6; 9.9 | — |
| SECONDARY All Death |
0.8; 0.8 | — |
| SECONDARY All Death |
0.8; 0.8 | — |
| SECONDARY All Death |
0.8; 0.8 | — |
| SECONDARY All Death |
0.8; 0.8 | — |
| SECONDARY All Death |
0.8; 0.8 | — |
| SECONDARY All Protocol MI (Including Q-wave or Non-Q-wave) |
1.1; 0.8 | — |
| SECONDARY All Protocol MI (Including Q-wave or Non-Q-wave) |
1.1; 0.8 | — |
| SECONDARY All Protocol MI (Including Q-wave or Non-Q-wave) |
1.1; 0.8 | — |
| SECONDARY All Protocol MI (Including Q-wave or Non-Q-wave) |
1.1; 0.8 | — |
| SECONDARY All Protocol MI (Including Q-wave or Non-Q-wave) |
1.1; 0.8 | — |
| SECONDARY Target Vessel Protocol MI (TV-MI) |
1.1; 0.8 | — |
| SECONDARY Target Vessel Protocol MI (TV-MI) |
1.1; 0.8 | — |
| SECONDARY Target Vessel Protocol MI (TV-MI) |
1.1; 0.8 | — |
| SECONDARY Target Vessel Protocol MI (TV-MI) |
1.1; 0.8 | — |
| SECONDARY Target Vessel Protocol MI (TV-MI) |
1.1; 0.8 | — |
| SECONDARY Major Bleeding Complications |
0.8; 0.0 | — |
| SECONDARY Major Bleeding Complications |
0.8; 0.0 | — |
| SECONDARY Major Bleeding Complications |
0.8; 0.0 | — |
| SECONDARY Major Bleeding Complications |
0.8; 0.0 | — |
| SECONDARY Major Bleeding Complications |
0.8; 0.0 | — |
| SECONDARY Definite / Probable Stent Thrombosis |
0.54; 0.00 | — |
| SECONDARY Definite / Probable Stent Thrombosis |
0.54; 0.00 | — |
| SECONDARY Definite / Probable Stent Thrombosis |
0.54; 0.00 | — |
| SECONDARY Definite / Probable Stent Thrombosis |
0.54; 0.00 | — |
| SECONDARY Definite / Probable Stent Thrombosis |
0.54; 0.00 | — |
| SECONDARY Definite / Probable Stent Thrombosis |
0.54; 0.00 | — |
| SECONDARY Patient Compliance With Dual Antiplatelet Therapy (DAPT) |
58.0; 55.4 | — |
| SECONDARY Patient Compliance With Dual Antiplatelet Therapy (DAPT) |
58.0; 55.4 | — |
| SECONDARY Patient Compliance With Dual Antiplatelet Therapy (DAPT) |
58.0; 55.4 | — |
| SECONDARY Patient Compliance With Dual Antiplatelet Therapy (DAPT) |
58.0; 55.4 | — |
| SECONDARY Patient Compliance With Dual Antiplatelet Therapy (DAPT) |
58.0; 55.4 | — |
| SECONDARY Acute Device Success |
97.2; 98.4 | — |
| SECONDARY Acute Procedure Success |
98.1; 99.2 | — |
| SECONDARY Procedure Time |
29.6; 28.6 | — |
| SECONDARY Amount of Contrast Used |
132.1; 145.4 | — |
| SECONDARY Fluoroscopy Time |
7.0; 7.4 | — |
| SECONDARY XIENCE V EECSS Excellent Overall Performance and Deliverability Using the XIENCE V EECSS Performance Evaluation Questionnaire |
93.2 | — |
| SECONDARY Follow-up Late Loss |
0.15; 0.27; 0.20; 0.33; 0.11; 0.20 | — |
| SECONDARY Follow-up In-stent Minimum Lumen Diameter (MLD) |
2.62; 2.63 | — |
| SECONDARY Follow-up In-stent Percent Diameter Stenosis (DS) |
10.56; 11.82 | — |
| SECONDARY Follow-up In-stent Angiographic Binary Restenosis (ABR) |
1.1; 1.0 | — |
| SECONDARY Follow-up In-segment Minimum Lumen Diameter (MLD) |
2.34; 2.33 | — |
| SECONDARY Follow-up In-segment Percent Diameter Stenosis (DS) |
16.79; 18.79 | — |
| SECONDARY Follow-up In-segment Angiographic Binary Restenosis (ABR) |
2.1; 3.1 | — |
| SECONDARY Percent Diameter Stenosis |
64.97; 64.95 | — |
| SECONDARY Percent Diameter Stenosis (%DS) |
8.09; 8.56; 14.40; 12.46 | — |
| SECONDARY Acute Gain |
1.79; 1.77; 1.48; 1.52; 2.03; 2.06 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT01178268). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.