Trials / Completed
CompletedNCT01243749
RESOLUTE China Registry:
Evaluation of the Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in a Real-World Patient Population in China
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,800 (actual)
- Sponsor
- Medtronic Vascular · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To document the safety and overall clinical performance of the Resolute Zotarolimus-Eluting Coronary Stent System in a real-world patient population requiring stent implantation.
Detailed description
The Resolute stent is designed to support the approach of delivering drug to the coronary arterial tissue over a longer period of time than that offered by current approved DES products. This method of prolonged drug elution may address the need to control local vascular neointimal proliferation in patients with complex lesions for extended therapeutic effect. The purpose of this multi-center trial is to investigate the clinical safety and efficacy of the Endeavor Resolute drug-eluting stent in every-day patients, like stable and unstable patients with single or multi-vessel disease and/or complex lesions. Patients should be treated according to normal hospital routine practice and in line with the applicable guidelines on percutaneous coronary interventions and the Instructions For Use of the device. 1800 patients will be enrolled from China at approximately 40 centers where Endeavor Resolute stent is commercially available.
Conditions
- Ischemic Heart Disease
- Stenotic Coronary Lesion
- Cardiovascular Diseases
- Arteriosclerosis
- Coronary Artery Disease
Timeline
- Start date
- 2010-12-01
- Primary completion
- 2013-04-01
- Completion
- 2017-12-15
- First posted
- 2010-11-18
- Last updated
- 2018-04-05
Locations
6 sites across 1 country: China
Source: ClinicalTrials.gov record NCT01243749. Inclusion in this directory is not an endorsement.