N/A Completed N=458 Randomized Double-blind Treatment

Randomized MicroPort's Firehawk DES Versus Xience V: TARGET I Trial

Coronary Artery Disease

Source: ClinicalTrials.gov NCT01196819 ↗

Enrolled (actual)

458

Serious AEs

16.4%

Results posted

Feb 2018

Primary outcomePrimary: 9 Months In-stent Late Lumen Loss — 0.13; 0.13 mm — p=0.94

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY 9 Months In-stent Late Lumen Loss	0.13; 0.13	0.94
SECONDARY 9 Months In-stent Diameter Stenosis	11.51; 11.85	0.69
SECONDARY Target Lesion Failure(TLF) Rate	2.2; 2.2	1.0
SECONDARY TLF(Target Lumen Failure) Rate	3.51; 4.05	0.76
SECONDARY TLF(Target Lumen Failure)	6.67; 5.99	0.77
SECONDARY Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)	1; 0	—

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01196819). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.