Status:
COMPLETED
RESOLUTE China Registry:
Lead Sponsor:
Medtronic Vascular
Conditions:
Ischemic Heart Disease
Stenotic Coronary Lesion
Eligibility:
All Genders
18+ years
Brief 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 o...
Eligibility Criteria
Inclusion
- Patient must meet all of the following criteria to be eligible for treatment in the trial:
- Age ≥ 18 years or minimum age as required by local regulations
- The patient is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, the Instructions for Use of the Resolute stent and the Declaration of Helsinki
- The patient or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his/her medical information by signing a Patient Informed Consent Form
- Intention to electively implant at least one Resolute stent
- The patient is willing and able to cooperate with study procedures and required follow up visits
Exclusion
- Patients will be excluded from the trial if any of the following criteria are met:
- Known intolerance to aspirin, clopidogrel or ticlopidin, heparin, bivalirudin, cobalt, nickel, chromium, molybdenum, polymer coatings (e.g. Biolinx), zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative, or contrast media
- Women with known pregnancy or who are lactating
- High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
- Currently participating in another trial that has not completed the primary endpoint or that clinically interferes with the current trial requirements
- Planned surgery within 6 months of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period
- Previous enrollment in the Resolute China Registry
Key Trial Info
Start Date :
December 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 15 2017
Estimated Enrollment :
1800 Patients enrolled
Trial Details
Trial ID
NCT01243749
Start Date
December 1 2010
End Date
December 15 2017
Last Update
April 5 2018
Active Locations (6)
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1
Beijing Fumwai Hospital
Beijing, China, 100000
2
Peiking University People's Hospital
Beijing, China, 100044
3
Fujian Medical University Union Hospital
Fuzhou, China, 350001
4
Guangdong Provincial People's Hospital
Guangdong, China, 510000