Status:
COMPLETED
Randomized MicroPort's Firehawk DES Versus Xience V: TARGET I Trial
Lead Sponsor:
Shanghai MicroPort Medical (Group) Co., Ltd.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
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 (...
Eligibility Criteria
Inclusion
- 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
- 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
- Heart implantation cases
- Pre-specified OCT inclusion/exclusion criteria:
- Patients underwent 9-month angio F/U
- No binary restenosis at 9-month
- LLL between -0.01\~0.2mm
- No mix-implanted stent
- No more than one bail-out stent
- No TLR occurred at 3 years after PCI
- The target vessel able to deliver the OCT catheter
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
458 Patients enrolled
Trial Details
Trial ID
NCT01196819
Start Date
September 1 2010
End Date
December 1 2016
Last Update
July 30 2019
Active Locations (1)
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1
Fuwai Hospital
Beijing, China, 100037