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| Study Type: | Interventional |
|---|---|
| Study Design: | Randomized, Single Blind (Subject), Active Control, Parallel Assignment |
| Conditions: |
Stents Coronary Artery Disease Total Coronary Occlusion Coronary Artery Restenosis Stent Thrombosis Vascular Disease Myocardial Ischemia Coronary Artery Stenosis |
| Interventions: |
Device: XIENCE V® Everolimus Eluting Coronary Stent Device: TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent |
Baseline Characteristics
| Description | |
|---|---|
| XIENCE V® EECSS | XIENCE V® Everolimus Eluting Coronary Stent System |
| TAXUS® EXPRESS2™ ECSS | TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332. |
| XIENCE V® EECSS | TAXUS® EXPRESS2™ ECSS | Total | |
|---|---|---|---|
|
Number of Participants [units: participants] |
669 | 333 | 1002 |
|
Age[1] [units: participants] |
|||
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 376 | 191 | 567 |
| >=65 years | 293 | 141 | 434 |
|
Age[2] [units: years] Mean ± Standard Deviation |
63.23 ± 10.53 | 62.80 ± 10.24 | 63.08 ± 10.43 |
|
Gender[3] [units: participants] |
|||
| Female | 200 | 114 | 314 |
| Male | 469 | 218 | 687 |
|
Region of Enrollment[4] [units: participants] |
|||
| United States | 669 | 333 | 1002 |
| [1] | 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332. |
|---|---|
| [2] | 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332. |
| [3] | 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332. |
| [4] | 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332. |
Outcome Measures
| 1. Primary: | Primary Endpoint: In-segment Late Loss (LL) [ 240 days ] |
| 2. Secondary: | Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF) [ 270 days ] |
| 3. Secondary: | Target Vessel Failure (TVF) [ 30 days ] |
| 4. Secondary: | Target Vessel Failure (TVF) [ 180 days ] |
| 5. Secondary: | Target Vessel Failure (TVF) [ 1 year ] |
| 6. Secondary: | Target Vessel Failure (TVF) [ 2 year ] |
| 7. Secondary: | Ischemia Driven Target Lesion Revascularization (ID-TLR) [ 30 days ] |
| 8. Secondary: | Ischemia Driven Target Lesion Revascularization (ID-TLR) [ 180 days ] |
| 9. Secondary: | Ischemia Driven Target Lesion Revascularization (ID-TLR) [ 270 days ] |
| 10. Secondary: | Ischemia Driven Target Lesion Revascularization (ID-TLR) [ 1 years ] |
| 11. Secondary: | Ischemia Driven Target Lesion Revascularization (ID-TLR) [ 2 years ] |
| 12. Secondary: | Ischemia Driven Target Vessel Revascularization (ID-TVR) [ 30 days ] |
| 13. Secondary: | Ischemia Driven Target Vessel Revascularization (ID-TVR) [ 180 days ] |
| 14. Secondary: | Ischemia Driven Target Vessel Revascularization (ID-TVR) [ 270 days ] |
| 15. Secondary: | Ischemia Driven Target Vessel Revascularization (ID-TVR) [ 1 year ] |
| 16. Secondary: | Ischemia Drive Target Vessel Revascularization (ID-TVR) [ 2 years ] |
| 17. Secondary: | Ischemia Driven Major Adverse Cardiac Event (MACE) [ 30 days ] |
| 18. Secondary: | Ischemia Driven Major Adverse Cardiac Event (MACE) [ 180 days ] |
| 19. Secondary: | Ischemia Driven Major Adverse Cardiac Event (MACE) [ 270 days ] |
| 20. Secondary: | Ischemia Driven Major Adverse Cardiac Event (MACE) [ 1 year ] |
| 21. Secondary: | Ischemia Driven Major Adverse Cardiac Event(MACE) [ 2 years ] |
| 22. Secondary: | In-stent % Angiographic Binary Restenosis (% ABR) Rate [ at 240 days ] |
| 23. Secondary: | In-segment % Angiographic Binary Restenosis (% ABR) Rate [ 240 days ] |
| 24. Secondary: | Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection [ at 240 days ] |
| 25. Secondary: | Acute Success: Clinical Device [ In-hospital ] |
| 26. Secondary: | Acute Success: Clinical Procedure [ In-hospital ] |
| 27. Secondary: | Proximal Late Loss [ at 240 days ] |
| 28. Secondary: | Distal Late Loss [ 240 days ] |
| 29. Secondary: | In-stent Late Loss [ at 240 days ] |
| 30. Secondary: | % Volume Obstruction (% VO) [ at 240 days ] |
| 31. Secondary: | In-stent % Diameter Stenosis (% DS) [ at 240 days ] |
| 32. Secondary: | In-segment % Diameter Stenosis (% DS) [ 240 days ] |
More Information
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
| Responsible Party: | Abbott Vascular ( Abbott Vascular ) |
| Study ID Numbers: | 03-360 |
| Study First Received: | September 13, 2005 |
| Results First Received: | October 15, 2008 |
| Last Updated: | September 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00180479 History of Changes |
| Health Authority: | United States: Food and Drug Administration |