Overview

This trial is active, not recruiting.

Conditions ischemic heart disease, stenotic coronary lesion, cardiovascular diseases, arteriosclerosis, coronary artery disease
Sponsor Medtronic Vascular
Start date December 2010
End date April 2013
Trial size 1800 participants
Trial identifier NCT01243749, IP124

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
Target lesion failure (TLF)
time frame: 12m

Secondary Outcomes

Measure
Overall stent thrombosis
time frame: 12m
Device success, Lesion success, Procedural success
time frame: At the end of the index procedure or during hospital stay
TLF
time frame: 30 days, 6 months, 2 year, 3 year, 4 year and 5 year
All deaths (cardiac, vascular and non-cardiovascular)
time frame: 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Stent thrombosis rate
time frame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Myocardial infarction
time frame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Revascularization
time frame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Significant bleeding complications and stroke
time frame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Target vessel failure (TVF)
time frame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Major adverse cardiac events (MACE)
time frame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Patient must meet all of the following criteria to be eligible for treatment in the trial: 1. Age ≥ 18 years or minimum age as required by local regulations 2. 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 3. 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 4. Intention to electively implant at least one Resolute stent 5. The patient is willing and able to cooperate with study procedures and required follow up visits Exclusion Criteria: Patients will be excluded from the trial if any of the following criteria are met: 1. 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 2. Women with known pregnancy or who are lactating 3. High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) 4. Currently participating in another trial that has not completed the primary endpoint or that clinically interferes with the current trial requirements 5. Planned surgery within 6 months of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period 6. Previous enrollment in the Resolute China Registry

Additional Information

Official title RESOLUTE China Registry: Evaluation of the Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in a Real-World Patient Population in China
Principal investigator Shubin Qiao, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Medtronic Vascular.