Trial · NCT00307047
SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System
NCT00307047, Phase 3, Completed, Abbott Medical Devices; results first posted 2010-10-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System. Trials, record NCT00307047. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00307047
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System
- NCT number
- NCT00307047
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,687 participants, actual
- Lead sponsor
- Abbott Medical Devices
- Conditions
- Coronary Artery Disease
- Interventions
- XIENCE V® Everolimus Eluting Coronary Stent, TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
- First posted
- 2006-03-27
- Last updated
- 2012-11-07
- Results first posted
- 2010-10-21
Source ClinicalTrials.gov
Registered outcomes66
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ischemia Driven Target Lesion Failure (TLF) | 1 year | Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR). |
| Secondary | Ischemia Driven Target Vessel Failure (TVF) | 30 days | Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR |
| Secondary | Ischemia Driven Target Vessel Failure (TVF) | 180 days | Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR |
| Secondary | Ischemia Driven Target Vessel Failure (TVF) | 270 days | Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR |
| Secondary | Ischemia Driven Target Vessel Failure (TVF) | 1 year | Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR |
| Secondary | Ischemia Driven Target Vessel Failure (TVF) | 2 years | Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR |
| Secondary | Ischemia Driven Target Vessel Failure (TVF) | 3 years | Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR |
| Secondary | Ischemia Driven Target Lesion Revascularization (TLR) | 30 days | Revascularization of a target lesion associated with any of the following: * positive functional ischemia study * ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study |
| Secondary | Ischemia Driven Target Lesion Revascularization (TLR) | 180 days | Revascularization of a target lesion associated with any of the following: * positive functional ischemia study * ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study |
| Secondary | Ischemia Driven Target Lesion Revascularization (TLR) | 270 days | Revascularization of a target lesion associated with any of the following: * positive functional ischemia study * ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 registered outcomesOutcomes66
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Ischemia Driven Target Vessel Failure (TVF) | 30 days | percentage of participants | NUMBER | |
| SECONDARY | Ischemia Driven Target Vessel Failure (TVF) | 180 days | percentage of participants | NUMBER | |
| SECONDARY | Ischemia Driven Target Vessel Failure (TVF) | 270 days | percentage of participants | NUMBER | |
| SECONDARY | Ischemia Driven Target Vessel Failure (TVF) | 1 year | ITT, @ 1 yr | percentage of participants | NUMBER |
| SECONDARY | Ischemia Driven Target Vessel Failure (TVF) | 2 years | ITT, @ 2 years | percentage of participants | NUMBER |
| SECONDARY | Ischemia Driven Target Vessel Failure (TVF) | 3 years | ITT, @ 3 years | percentage of participants | NUMBER |
| SECONDARY | Ischemia Driven Target Lesion Revascularization (TLR) | 30 days | ITT population. | percentage of participants | NUMBER |
| SECONDARY | Ischemia Driven Target Lesion Revascularization (TLR) | 180 days | ITT population | percentage of participants | NUMBER |
| SECONDARY | Ischemia Driven Target Lesion Revascularization (TLR) | 270 days | ITT population | percentage of participants | NUMBER |
| SECONDARY | Ischemia Driven Target Lesion Revascularization (TLR) | 1 year | ITT population. | percentage of participants | NUMBER |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 outcomesResults by group132
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Ischemia Driven Target Vessel Failure (TVF) | XIENCE V® | 1.9 | percentage of participants | ||
| Ischemia Driven Target Vessel Failure (TVF) | TAXUS™ EXPRESS 2™ | 3.1 | percentage of participants | ||
| Ischemia Driven Target Vessel Failure (TVF) | XIENCE V® | 3.4 | percentage of participants | ||
| Ischemia Driven Target Vessel Failure (TVF) | TAXUS™ EXPRESS 2™ | 6.2 | percentage of participants | ||
| Ischemia Driven Target Vessel Failure (TVF) | XIENCE V® | 4.6 | percentage of participants | ||
| Ischemia Driven Target Vessel Failure (TVF) | TAXUS™ EXPRESS 2™ | 7.2 | percentage of participants | ||
| Ischemia Driven Target Vessel Failure (TVF) | XIENCE V® | 5.6 | percentage of participants | ||
| Ischemia Driven Target Vessel Failure (TVF) | TAXUS™ EXPRESS 2™ | 7.9 | percentage of participants | ||
| Ischemia Driven Target Vessel Failure (TVF) | XIENCE V® | 9.6 | percentage of participants | ||
| Ischemia Driven Target Vessel Failure (TVF) | TAXUS™ EXPRESS 2™ | 11.8 | percentage of participants |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | XIENCE V® | 2,458 | |
| Overall Study | STARTED | TAXUS™ EXPRESS 2™ | 1,229 | |
| Overall Study | COMPLETED | XIENCE V® | 2,389 | |
| Overall Study | COMPLETED | TAXUS™ EXPRESS 2™ | 1,180 | |
| Overall Study | NOT COMPLETED | XIENCE V® | 69 | |
| Overall Study | NOT COMPLETED | TAXUS™ EXPRESS 2™ | 49 |
Source ClinicalTrials.gov
Adverse events994
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Angina pectoris | Cardiac disorders | XIENCE V® | 398 | 2,436 | 493 |
| other | Angina pectoris | Cardiac disorders | TAXUS™ EXPRESS 2™ | 198 | 1,214 | 236 |
| other | Back pain | Musculoskeletal and connective tissue disorders | XIENCE V® | 193 | 2,436 | 194 |
| other | Back pain | Musculoskeletal and connective tissue disorders | TAXUS™ EXPRESS 2™ | 130 | 1,214 | 139 |
| other | Catheter site haematoma | General disorders | XIENCE V® | 177 | 2,436 | 181 |
| other | Catheter site haematoma | General disorders | TAXUS™ EXPRESS 2™ | 98 | 1,214 | 102 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | XIENCE V® | 121 | 2,436 | 126 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | TAXUS™ EXPRESS 2™ | 64 | 1,214 | 67 |
| serious | Abdominal hernia | Gastrointestinal disorders | XIENCE V® | 2 | 2,436 | 2 |
| serious | Abdominal hernia | Gastrointestinal disorders | TAXUS™ EXPRESS 2™ | 0 | 1,214 | 0 |
1 to 10 of 994Source ClinicalTrials.gov
See all 994 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | XIENCE V® | ||
| Total, all-cause mortality | TAXUS™ EXPRESS 2™ | ||
| Total, other adverse events | XIENCE V® | 762 | 2,436 |
| Total, other adverse events | TAXUS™ EXPRESS 2™ | 407 | 1,214 |
| Total, serious adverse events | XIENCE V® | 913 | 2,436 |
| Total, serious adverse events | TAXUS™ EXPRESS 2™ | 468 | 1,214 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| XIENCE V® vs TAXUS™ EXPRESS 2™: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00307047
GET https://conductscience.org/api/trials/v1/NCT00307047/registered?page=2