Phase 3
Completed N=1,002
SPIRIT III Clinical Trial of the XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
Stents · Coronary Artery Disease · Total Coronary Occlusion · Coronary Artery Restenosis
Source: ClinicalTrials.gov NCT00180479 ↗
Enrolled (actual)
1,002
Serious AEs
—
Results posted
Dec 2008
Primary outcomePrimary: Primary Endpoint: In-segment Late Loss (LL) — 0.14; 0.28 millimeters — p=<0.0001
Summary
This study is divided into 5 arms:
1. Randomized Clinical Trial (RCT): Prospective, randomized, active-controlled, single blind, parallel two-arm multi-center clinical trial in the United States (US) comparing XIENCE V® Everolimus Eluting Coronary Stent System (CSS) (2.5, 3.0, 3.5 mm diameter stents) to the Food and Drug Administration (FDA) approved commercially available active control TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent (TAXUS® EXPRESS2™ PECS) System
2. US 2.25 mm non-randomized arm using 2.25 mm diameter XIENCE V® Everolimus Eluting CSS
3. US 4.0 mm non-randomized arm using 4.0 mm diameter XIENCE V® Everolimus Eluting CSS
4. US 38 mm non-randomized arm using 38 mm in length XIENCE V® Everolimus Eluting CSS
5. Japanese non-randomized arm using XIENCE V® Everolimus Eluting CSS (2.5, 3.0, 3.5, 4.0 mm diameter stents) in Japan
The TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System is Manufactured by Boston Scientific.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Endpoint: In-segment Late Loss (LL) |
0.14; 0.28 | <0.0001 sig |
| SECONDARY Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF) |
7.2; 9.0 | <0.0001 sig |
| SECONDARY Target Vessel Failure (TVF) |
20.3; 26.6 | — |
| SECONDARY Target Vessel Failure (TVF) |
20.3; 26.6 | — |
| SECONDARY Target Vessel Failure (TVF) |
20.3; 26.6 | — |
| SECONDARY Target Vessel Failure (TVF) |
20.3; 26.6 | — |
| SECONDARY Target Vessel Failure (TVF) |
20.3; 26.6 | — |
| SECONDARY Target Vessel Failure (TVF) |
20.3; 26.6 | — |
| SECONDARY Ischemia Driven Target Lesion Revascularization (ID-TLR) |
8.9; 12.9 | — |
| SECONDARY Ischemia Driven Target Lesion Revascularization (ID-TLR) |
8.9; 12.9 | — |
| SECONDARY Ischemia Driven Target Lesion Revascularization (ID-TLR) |
8.9; 12.9 | — |
| SECONDARY Ischemia Driven Target Lesion Revascularization (ID-TLR) |
8.9; 12.9 | — |
| SECONDARY Ischemia Driven Target Lesion Revascularization (ID-TLR) |
8.9; 12.9 | — |
| SECONDARY Ischemia Driven Target Lesion Revascularization (ID-TLR) |
8.9; 12.9 | — |
| SECONDARY Ischemia Driven Target Lesion Revascularization (ID-TLR) |
8.9; 12.9 | — |
| SECONDARY Ischemia Driven Target Vessel Revascularization (ID-TVR) |
8.8; 11.9 | — |
| SECONDARY Ischemia Driven Target Vessel Revascularization (ID-TVR) |
8.8; 11.9 | — |
| SECONDARY Ischemia Driven Target Vessel Revascularization (ID-TVR) |
8.8; 11.9 | — |
| SECONDARY Ischemia Driven Target Vessel Revascularization (ID-TVR) |
8.8; 11.9 | — |
| SECONDARY Ischemia Driven Target Vessel Revascularization (ID-TVR) |
8.8; 11.9 | — |
| SECONDARY Ischemia Driven Target Vessel Revascularization (ID-TVR) |
8.8; 11.9 | — |
| SECONDARY Ischemia Driven Target Vessel Revascularization (ID-TVR) |
8.8; 11.9 | — |
| SECONDARY Ischemia Driven Major Adverse Cardiac Event (MACE) |
14.4; 22.0 | — |
| SECONDARY Ischemia Driven Major Adverse Cardiac Event (MACE) |
14.4; 22.0 | — |
| SECONDARY Ischemia Driven Major Adverse Cardiac Event (MACE) |
14.4; 22.0 | — |
| SECONDARY Ischemia Driven Major Adverse Cardiac Event (MACE) |
14.4; 22.0 | — |
| SECONDARY Ischemia Driven Major Adverse Cardiac Event(MACE) |
7.7; 13.8 | — |
| SECONDARY Ischemia Driven Major Adverse Cardiac Event (MACE) |
14.4; 22.0 | — |
| SECONDARY Ischemia Driven Major Adverse Cardiac Event (MACE) |
14.4; 22.0 | — |
| SECONDARY In-stent % Angiographic Binary Restenosis (% ABR) Rate |
2.3; 5.7 | — |
| SECONDARY In-segment % Angiographic Binary Restenosis (% ABR) Rate |
4.7; 8.9 | — |
| SECONDARY Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection |
24.4; 14.0 | — |
| SECONDARY Acute Success: Clinical Device |
98.3; 98.7 | — |
| SECONDARY Acute Success: Clinical Procedure |
98.5; 97.3 | — |
| SECONDARY Proximal Late Loss |
0.12; 0.20 | — |
| SECONDARY Distal Late Loss |
0.09; 0.10 | — |
| SECONDARY In-stent Late Loss |
0.16; 0.30 | — |
| SECONDARY % Volume Obstruction (% VO) |
6.91; 11.21 | — |
| SECONDARY In-stent % Diameter Stenosis (% DS) |
5.92; 10.30 | — |
| SECONDARY In-segment % Diameter Stenosis (% DS) |
18.77; 22.82 | — |
| SECONDARY Target Vessel Failure (TVF) |
20.3; 26.6 | — |
| SECONDARY Ischemia Driven Target Lesion Revascularization (ID-TLR) |
8.9; 12.9 | — |
| SECONDARY Ischemia Driven Target Vessel Revascularization (ID-TVR) |
8.8; 11.9 | — |
| SECONDARY Ischemia Driven Major Adverse Cardiac Event (MACE) |
14.4; 22.0 | — |
Eligibility Criteria
Inclusion Criteria
- Target lesion(s) must be located in a native epicardial vessel with visually estimated diameter between >= 2.25 mm and = 50% and = 1
- Non-study, percutaneous intervention for lesions in a non-target vessel is allowed if done >= 90 days prior to the index procedure (subjects who received brachytherapy will be excluded from the trial)
Exclusion Criteria
- Located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft
- Lesion involving a bifurcation >= 2 mm in diameter or ostial lesion > 50% stenosed by visual estimation or side branch requiring predilatation
- Located in a major epicardial vessel that has been previously treated with brachytherapy
- Located in a major epicardial vessel that has been previously treated with percutaneous intervention 40% diameter stenosis [DS]) is located in the same epicardial vessel as the target lesion
Data sourced from ClinicalTrials.gov (NCT00180479). 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.