N/A
Completed N=65
A Clinical Evaluation of the XIENCE PRIME Small Vessel Everolimus Eluting Coronary Stent System in Japanese Population
Vascular Disease · myocardial ischemia · Coronary Artery Stenosis · Coronary Disease
Source: ClinicalTrials.gov NCT01115933 ↗
Enrolled (actual)
65
Serious AEs
15.6%
Results posted
Jan 2014
Primary outcomePrimary: Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (TLF) — 0.00 percentage of participants
Summary
The purpose of this study is to evaluate the safety and effectiveness of the AVJ-09-385 Small Vessel Everolimus Eluting Coronary Stent System (EECSS) (2.25 mm diameter stent) in treatment of subjects with ischemic heart disease caused by de novo lesions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (TLF) |
0.00 | — |
| SECONDARY Device Success (Lesion Based Analysis, Only for XIENCE PRIME SV) |
100.00 | — |
| SECONDARY Procedural Success(Subject Base Analysis) |
100.00 | — |
| SECONDARY Percent Diameter Stenosis (%DS), In-segment, In-stent, Proximal and Distal |
19.80; 6.11; 12.32; 14.91 | — |
| SECONDARY Late Loss (LL), In-segment, In-stent, Proximal and Distal |
0.12; 0.13; 0.08; 0.08 | — |
| SECONDARY Angiographic Binary Restenosis (ABR), In-segment, In-stent, Proximal and Distal |
4.8; 0; 3.7; 0 | — |
| SECONDARY Death (Cardiac, Vascular, Non-Cardiovascular, Per ARC Definition) |
1.6; 0.00; 0.00; 1.6 | — |
| SECONDARY Death (Cardiac, Vascular, Non-Cardiovascular, Per ARC Definition) |
1.6; 0.00; 0.00; 1.6 | — |
| SECONDARY Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) |
0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) |
0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Attributable to Target Vessel (TV-MI) |
0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Attributable to Target Vessel (TV-MI) |
0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Not Attributable to Target Vessel (NTV-MI) |
0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Not Attributable to Target Vessel (NTV-MI) |
0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Target Lesion Revascularization (TLR, Per ARC Definition) |
3.1 | — |
| SECONDARY Target Lesion Revascularization (TLR, Per ARC Definition) |
3.1 | — |
| SECONDARY Target Lesion Revascularization (TLR, Per ARC Definition) Clinically-indicated TLR (CI-TLR) |
0.00 | — |
| SECONDARY Target Lesion Revascularization (TLR, Per ARC Definition) Clinically-indicated TLR (CI-TLR) |
0.00 | — |
| SECONDARY Target Lesion Revascularization (TLR, Per ARC Definition) Not Clinically-indicated TLR (NCI-TLR) |
3.1 | — |
| SECONDARY Target Lesion Revascularization (TLR, Per ARC Definition) Not Clinically-indicated TLR (NCI-TLR) |
3.1 | — |
| SECONDARY Target Vessel Revascularization (TVR, Per ARC Definition) |
3.1 | — |
| SECONDARY Target Vessel Revascularization (TVR, Per ARC Definition) |
3.1 | — |
| SECONDARY Target Vessel Revascularization (TVR, Per ARC Definition) Clinically-indicated TVR (CI-TVR) |
1.6 | — |
| SECONDARY Target Vessel Revascularization (TVR, Per ARC Definition) Clinically-indicated TVR (CI-TVR) |
1.6 | — |
| SECONDARY Target Vessel Revascularization (TVR, Per ARC Definition) Not Clinically-indicated TVR (NCI-TVR) |
3.1 | — |
| SECONDARY Target Vessel Revascularization (TVR, Per ARC Definition) Not Clinically-indicated TVR (NCI-TVR) |
3.1 | — |
| SECONDARY Composite Endpoint of Cardiac Death/All MI |
0.0 | — |
| SECONDARY Composite Endpoint of Cardiac Death/All MI |
0.0 | — |
| SECONDARY Composite Endpoint of All Death/All MI/All Revascularization (DMR) |
10.9 | — |
| SECONDARY Composite Endpoint of All Death/All MI/All Revascularization (DMR) |
10.9 | — |
| SECONDARY Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (TLF) |
0.00 | — |
| SECONDARY Composite Endpoint of Cardiac Death/All MI/CI-TLR (MACE) |
0.00 | — |
| SECONDARY Composite Endpoint of Cardiac Death, All MI and CI-TLR (MACE) |
0.0 | — |
| SECONDARY All Coronary Revascularization |
0.0 | — |
| SECONDARY All Coronary Revascularization |
0.0 | — |
| SECONDARY Acute Stent Thrombosis |
0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Subacute Stent Thrombosis |
0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Acute/Subacute Stent Thrombosis |
0.0; 0.0; 0.00; 0.00; 0.0 | — |
| SECONDARY Late Stent Thrombosis |
0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Overall Stent Thrombosis |
0.0; 0.0; 0.0; 0.0; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Subject must be at least 20 years of age.
- Subject or a legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements.
- Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia).
- Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
- Subject must agree to undergo all protocol-required follow-up procedures.
- Subject must agree not to participate in any other clinical study for a period of one year following the index procedure.
Angiographic Inclusion Criteria
- One (target) or two (one target and one non-target) de novo lesions each in a different epicardial vessel.
- Lesion(s) must be located in a major artery or branch with a visually estimated diameter stenosis of ≥ 50% and 700,000 cells/mm3, a white blood cell (WBC) of 20% stenosed lesion) arterial or saphenous vein graft.
- Target lesion involving a bifurcation with a side branch ≥ 2 mm in diameter and/or ostial lesion > 40% stenosed or side branch requiring protection guidewire, or side branch requiring dilatation.
- Target lesion with total occlusion (TIMI flow 0), prior to crossing with the wire.
- Another lesion requiring revascularization is located in the same epicardial vessel of the target lesion.
- Restenotic lesion.
- Aorto-ostial target lesion (within 3 mm of the aorta junction).
- Lesion in the left main trunk (both target and non-target).
- Lesion located within 2 mm of the origin of the LAD or LCX.
- Extreme angulation (≥ 90 °) or excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
- Heavy calcification proximal to or within the target lesion.
- Target vessel contains thrombus as indicated in the angiographic images.
- Target lesion has a high probability that a procedure other than pre-dilatation and stenting will be required at the time of index procedure for treatment of the target vessel (e.g. rotablator, DCA, cutting balloon).
- Target vessel is previously treated* with any type of PCI (e.g. balloon angioplasty, stent, rotablator, DCA, cutting balloon) within 9 months of index procedure.
- Non-target vessel was previously treated with any type of PCI within 90 days of index procedure.
- Additional clinically significant lesion(s) in the target vessel or side branch for which PCI may be required within 90 days after the index procedure.
- Target lesion must be separated ≥ 5 mm from a previously treated lesion (stenosis within 5 mm of previously treated lesion is regarded as "restenosis").
Data sourced from ClinicalTrials.gov (NCT01115933). 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.