Trials / Completed
CompletedNCT01178268
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 546 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, randomized, active-controlled, open label, parallel two-arm, multi-center, post-approval study descriptively comparing the XIENCE V EECSS to the CYPHER SELECT PLUS Sirolimus-Eluting Coronary Stent System (SECSS) ("CYPHER SELECT PLUS") during commercial use in China.
Detailed description
Objectives * Confirm the safety and effectiveness of the XIENCE V EECSS for the treatment of patients in China * Evaluate patient compliance with dual antiplatelet therapy (DAPT) * Evaluate physician-determined XIENCE V EECSS acute performance, deliverability, and resource utilization
Conditions
- Coronary Occlusion
- Thrombosis (Stent Thrombosis)
- Vascular Disease
- Myocardial Ischemia
- Coronary Artery Stenosis
- Coronary Disease
- Coronary Artery Disease
- Coronary Restenosis
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | XIENCE V EECSS | Patients who will receive this stent. |
| DEVICE | CYPHER SELECT PLUS SECSS | Patients who will receive this stent. |
Timeline
- Start date
- 2010-08-01
- Primary completion
- 2012-10-01
- Completion
- 2014-09-01
- First posted
- 2010-08-10
- Last updated
- 2016-08-24
- Results posted
- 2016-08-24
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT01178268. Inclusion in this directory is not an endorsement.