RESOLUTE China RCT

Launched by MEDTRONIC VASCULAR · Apr 12, 2011

Keywords

ClinConnect Summary

This study is a prospective, multicenter, randomized, two-arm, open-label study, designed to assess the non-inferiority of Resolute stent compared to Taxus Liberte stent in in-stent late lumen loss.

The primary objective of this study is to evaluate the in-stent late lumen loss (LLL) at 9 months, defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiography MLD, of the Resolute Zotarolimus-Eluting Coronary Stent System compared to Taxus Liberte Paclitaxel-Eluting Coronary Stent System in a real-world all-comer patient population requiring s...

Gender

ALL

Eligibility criteria

• 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 Taxus Liberte 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 or Taxus Liberte 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, 316L stainless steel, polymer coatings (e.g. Biolinx), zotarolimus, paclitaxel, 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 RCT