Clinical trial NCT01196819: Randomized MicroPort's Firehawk DES Versus Xience V: TARGET I Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-09-08
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: 9 Months In-stent Late Lumen Loss
timeFrame: 9 months
Secondary outcomes:
measure: 9 Months In-stent Diameter Stenosis
timeFrame: 9 months
measure: Target Lesion Failure(TLF) Rate
timeFrame: 1 years after index PCI
measure: TLF(Target Lumen Failure) Rate
timeFrame: 3 years after index PCI (Percutaneous Coronary Intervention)
measure: TLF(Target Lumen Failure)
timeFrame: 5 years after index PCI
measure: Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)
timeFrame: 1 years after index PCI
measure: Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)
timeFrame: 3 years after index PCI
measure: Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)
timeFrame: 5 years after index PCI
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
Study officials:
affiliation: Fuwai Hospital, Beijing, China
name: Runlin Gao, Pro & MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li CJ, Xu B, Guan CD, Gao RL; TARGETⅠTrial Investigators. [Long term safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of coronary de novo lesions]. Zhonghua Xin Xue Guan Bing Za Zhi. 2017 Nov 24;45(11):940-947. doi: 10.3760/cma.j.issn.0253-3758.2017.11.009. Chinese.
citation: Gao Z, Zhang R, Xu B, Yang Y, Ma C, Li H, Chen S, Han Y, Yuan Z, Lansky AJ, Guan C, Leon MB, Gao R; TARGET Investigators. Safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of de novo coronary lesions: two-year results from a prospective patient-level pooled analysis of TARGET trials. Catheter Cardiovasc Interv. 2015 Mar;85 Suppl 1:734-43. doi: 10.1002/ccd.25861. Epub 2015 Feb 19.
citation: Gao RL, Xu B, Lansky AJ, Yang YJ, Ma CS, Han YL, Chen SL, Li H, Zhang RY, Fu GS, Yuan ZY, Jiang H, Huo Y, Li W, Zhang YJ, Leon MB; TARGET I Investigators. A randomised comparison of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: clinical and angiographic follow-up of the TARGET I trial. EuroIntervention. 2013 May 20;9(1):75-83. doi: 10.4244/EIJV9I1A12.