SMTPL - SIMPLE I

CLINICAL TRIALS > INFINNIUM SIMPLE I

Infinnium^®

SIMPLE I

Study Design

Principal Investigator:	Prof. D. S. Gambhir
Study Design:	Open labeled, Retrospective, Non randomized, Multicenter study, A total of 282 patients had been enrolled,
	maximum 50 & minimum 1 subject in up to 48 sites in the country.
Objective:	The primary objective of this study was to assess the safety and efficacy of the Infinnium^® Paclitaxel Eluting Stent
	in real world coronary artery lesions
Patient Enrollment:	Enrollment of 282 patients with proven coronary artery disease of lesion ≤ 25 mm in length in a vessel 2.5 mm –
	3.5 mm in diameter.
Status:	Complete

BASELINE DEMOGRAPHICS	N (%)
Diabetes	94 (33.3%)
Dyslipidemia	70 (24.8%)
Multiple Risk factors	126 (44.7%)
LESION COMPLEXITY	N (%)
Long Stenosis (> 15mm)	145 (51.4%)
CTO	72 (25.5%)
SVG Stenosis	7 (2.5%)
Left Main Stenosis	3 (1.1%)
Multivessel Stenting	30 (10.6%)
QCA at 6 Month: IN-STENT ANALYSIS	N=90
Reference Diameter (mm)	2.70 ą 0.55
MLD (mm) Pre	0.92 ą 0.42
Post	2.44 ą 0.39
F-up	2.28 ą 0.69
Late Loss (mm)	0.20 ą 0.66
Late Loss Index (mm)	0.16 ą 0.48
%DS (mm) F-up	18.8 ą 18.2
Restenosis Rate (%)	5.9
OVERALL MACE UPTO 3 YEARS F-up	N=260
Myocardial Infarction	2.1 %
Death	3.9 %
Cardiac	2.5 %
Non-Cardiac	1.4 %
TLR	6.7 %
TVR	8.1 %
Stent Thrombosis	2.1 %
MACE	12.4 %

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