Phase 4
Completed N=324
SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions (Diabetic Sub-Study)
Coronary Disease · Coronary Artery Disease · Coronary Restenosis
Source: ClinicalTrials.gov NCT01171820 ↗
Enrolled (actual)
324
Serious AEs
44.1%
Results posted
Oct 2010
Primary outcomePrimary: In-stent Late Loss (LL) — 0.39; 0.19 millimeters
Summary
The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery lesions in patients (Diabetic sub-study).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY In-stent Late Loss (LL) |
0.39; 0.19 | — |
| SECONDARY Clinical Device Success (Per-lesion) |
98.50; 97.58 | — |
| SECONDARY Clinical Procedure Success (Per-patient) |
93.14; 96.70 | — |
| SECONDARY In-segment Late Loss |
0.22; 0.12 | — |
| SECONDARY Proximal Late Loss |
0.17; 0.13 | — |
| SECONDARY Distal Late Loss |
0.0; 0.0 | — |
| SECONDARY In-stent Angiographic Binary Restenosis Rate |
6.1; 3.1 | — |
| SECONDARY In-segment Angiographic Binary Restenosis Rate |
6.4; 7.5 | — |
| SECONDARY In-stent Percent Diameter Stenosis (% DS) |
20.70; 14.33 | — |
| SECONDARY In-segment Percent Diameter Stenosis (% DS) |
23.87; 22.42 | — |
| SECONDARY Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible) |
2.88; 0.47 | — |
| SECONDARY Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated. |
14.42; 20.93 | — |
| SECONDARY Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR) |
12.50; 11.16 | — |
| SECONDARY Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR) |
16.35; 16.28 | — |
| SECONDARY Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non-TVR) |
10.38; 3.21 | — |
| SECONDARY Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR) |
23.08; 24.19 | — |
Eligibility Criteria
Inclusion Criteria
- at least 18 years
- able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the XIENCE V® EECSS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site
- diagnosed with diabetes, as documented by medical history.
- evidence of myocardial ischemia
- acceptable candidate for coronary artery bypass grafting (CABG) surgery
- agree to undergo all clinical investigation plan (CIP)-required follow-up examinations
- artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned stents
- maximum of one, de novo, target lesion per native major epicardial vessel or side branch
- target vessel reference diameter must be between 2.25 mm and 4.0 mm by visual estimate
- target lesion ≤ 28 mm in length by visual estimate
- target lesion must be in a major artery or branch with a visually estimated stenosis of > 50% and 1
Exclusion Criteria
- known diagnosis of acute myocardial infarction within 72 hours preceding the index procedure
- current unstable arrhythmias
- Left ventricular ejection fraction 20% stenosed lesion by visual estimation)
- lesion involving a side branch ≥ 2.5 mm in diameter
- lesion involving a side branch with > 50% stenosis by visual estimation Lesion involving a side branch requiring predilatation
- located in a major epicardial vessel that has been previously treated with brachytherapy
- located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, cutting balloon, atherectomy), 50% diameter stenosis) in a target vessel or side branch for which an intervention within 9 months after the index procedure may be required
Data sourced from ClinicalTrials.gov (NCT01171820). 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.