Trial · NCT00617084
Randomized, Two-arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent
NCT00617084, Phase 4, Completed, Medtronic Vascular; results first posted 2011-05-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Randomized, Two-arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent. Trials, record NCT00617084. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00617084
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized, Two-arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent
- NCT number
- NCT00617084
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 2,292 participants, actual
- Lead sponsor
- Medtronic Vascular
- Conditions
- Coronary Artery Disease
- Interventions
- Medtronic Endeavor Resolute, Abbott Xience V
- First posted
- 2008-02-15
- Last updated
- 2014-06-06
- Results first posted
- 2011-05-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Target Lesion Failure | 12 months | Percentage of participants that had either Cardiac Death, Myocardial Infarction (not clearly attributable to a non-target vessel)or Target Lesion Revascularization (TLR, clinically indicated) after one year. MI: Q MI if new pathological Q waves and chest pain, non Q MI if CK elevated more than two times normal, troponin elevated more than normal, according to ARC definitions. TLR, clinically indicated if associated with ischemic symptoms and angiographic min lumen diameter bigger than fifty percent by QCA or without symptoms and min lumen diameter bigger than seventy percent. Measure average. |
| Secondary | In-Stent Percent Diameter Stenosis | 13 Months | In Stent Percent Diameter Stenosis at thirteen months. In Stent Percent Diameter Stenosis: measured percent of diameter stenosis at the region of the stent (calculated as 100x(RVD-MLD)/RVD using the mean values from 2 orthogonal views by QCA. RVD (Reference Vessel Diameter): average of normal segments within 10mm proximal and distal to target lesion from 2 orthogonal views using QCA. MLD (Minimal Lumen Diameter): average of 2 orthogonal views of the narrowest point wihtin the area of assessment. MLD measured during QCA by the angiographic core laboratory. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Target Lesion Failure | 12 months | Analysis per intention to treat | percentage of participants | NUMBER |
| SECONDARY | In-Stent Percent Diameter Stenosis | 13 Months | Percentage diameter stenosis | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Target Lesion Failure | 1. Resolute - 12-13 Months | 8.2 | 8.2 to 8.2 | percentage of participants | |
| Target Lesion Failure | 2. XIENCE V - 12-13 Months | 8.3 | 8.3 to 8.3 | percentage of participants | |
| In-Stent Percent Diameter Stenosis | 1. Resolute - 12-13 Months | 21.65 | Standard Deviation 14.42 | Percentage diameter stenosis | |
| In-Stent Percent Diameter Stenosis | 2. XIENCE V - 12-13 Months | 19.76 | Standard Deviation 14.64 | Percentage diameter stenosis |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1. Resolute - 12-13 Months | 1,140 | |
| Overall Study | STARTED | 2. XIENCE V - 12-13 Months | 1,152 | |
| Overall Study | COMPLETED | 1. Resolute - 12-13 Months | 1,119 | |
| Overall Study | COMPLETED | 2. XIENCE V - 12-13 Months | 1,126 | |
| Overall Study | NOT COMPLETED | 1. Resolute - 12-13 Months | 21 | |
| Overall Study | NOT COMPLETED | 2. XIENCE V - 12-13 Months | 26 |
Source ClinicalTrials.gov
Adverse events662
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 | Chest Pain | General disorders | 1. Resolute - 12-13 Months | 0 | 1,140 | 0 |
| other | Chest Pain | General disorders | 2. XIENCE V - 12-13 Months | 59 | 1,152 | 62 |
| serious | Anaemia | Blood and lymphatic system disorders | 1. Resolute - 12-13 Months | 11 | 1,140 | 15 |
| serious | Anaemia | Blood and lymphatic system disorders | 2. XIENCE V - 12-13 Months | 7 | 1,152 | 10 |
| serious | Iron Deficiency Anaemia | Blood and lymphatic system disorders | 1. Resolute - 12-13 Months | 1 | 1,140 | 1 |
| serious | Iron Deficiency Anaemia | Blood and lymphatic system disorders | 2. XIENCE V - 12-13 Months | 0 | 1,152 | 0 |
| serious | Pancytopenia | Blood and lymphatic system disorders | 1. Resolute - 12-13 Months | 1 | 1,140 | 1 |
| serious | Pancytopenia | Blood and lymphatic system disorders | 2. XIENCE V - 12-13 Months | 0 | 1,152 | 0 |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | 1. Resolute - 12-13 Months | 0 | 1,140 | 0 |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | 2. XIENCE V - 12-13 Months | 1 | 1,152 | 1 |
1 to 10 of 662Source ClinicalTrials.gov
See all 662 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1. Resolute - 12-13 Months | ||
| Total, all-cause mortality | 2. XIENCE V - 12-13 Months | ||
| Total, other adverse events | 1. Resolute - 12-13 Months | 0 | 1,140 |
| Total, other adverse events | 2. XIENCE V - 12-13 Months | 59 | 1,152 |
| Total, serious adverse events | 1. Resolute - 12-13 Months | 435 | 1,140 |
| Total, serious adverse events | 2. XIENCE V - 12-13 Months | 432 | 1,152 |
Source ClinicalTrials.gov
Papers21
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 |
|---|
| 1. Resolute - 12-13 Months vs 2. XIENCE V - 12-13 Months: 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/NCT00617084
GET https://conductscience.org/api/trials/v1/NCT00617084/events?page=2