A Prospective Multi-center Randomized Trial Assessing the Safety and Effectiveness of Biodegradable Polymer Target Release Rapamycin-Eluting STent vs. XIENCE V Everolimus-Eluting Stent for the Treatment of Coronary Artery Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
- Enrollment
- 458
- Locations
- 1
- Primary Endpoint
- 9 Months In-stent Late Lumen Loss
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this study is to evaluate new generation drug eluting stent (DES) of MicroPort of its safety, efficacy and delivery system in treating CAD.
Detailed Description
The primary endpoint is in-stent late lumen loss after 9 months of the stent implantation. The secondary endpoint is in-stent percent diameter stenosis.This study is based on non-inferior assumption (vs. Xience V), requiring both endpoints reach statistical significance. Prespecified OCT follow-up is planned at 3-Year after index procedure at 3 chosen hospitals.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18-75, male or women who are not pregnant
- •Evidence of non-symptomatic ischemia, stable or non-stable angina or past heart attack cases
- •Target lesion is primary, single artery and single lesion of coronary artery
- •Target lesion vessel length ≤24mm, diameter 2.25mm-4.0mm
- •Lesion diameter stenosis ≥70%
- •Candidates understand the study, willing to sign Consent of Agreement and to willing to accept follow-up For long lesion group, at least one target lesion length ≥28mm，diameter 2.5mm-4.0mm, and one lesion needs to implant 33mm 0r 38mm long stent
Exclusion Criteria
- •Acute heart attack within one week
- •Chronic complete stenosis (TIMI 0), left main lesion, three branches need to treat, branch vessel diameter ≤2.5mm and bypass lesion
- •Calcified lesion failed in pre-dilation and twisted lesion
- •In-stent restenosis
- •Stent implanted within one year
- •Severe heart failure (NYHA above III) or left ventricle EF \<40%
- •Renal function damage, blood creatinine \>2.0mg/dl
- •Bleeding risk; allergic to drugs and agents used in procedure/treatment
- •Life expectation \< 12 months
- •No compliances to the protocol
Outcomes
Primary Outcomes
9 Months In-stent Late Lumen Loss
Time Frame: 9 months
To observe in-stent late lumen loss after 9 months of stent implantation It means the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 9 months after the procedure
Secondary Outcomes
- 9 Months In-stent Diameter Stenosis(9 months)
- Target Lesion Failure(TLF) Rate(1 years after index PCI)
- Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)(5 years after index PCI)
- TLF(Target Lumen Failure) Rate(3 years after index PCI (Percutaneous Coronary Intervention))
- TLF(Target Lumen Failure)(5 years after index PCI)