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SUPRALIMUS SERIES I
Supralimus
®
SERIES I
Study Design
Principal Investigator:
Dr. Sameer Dani
Study Title:
A study with the Supralimus
®
Sirolimus
Eluting Stent in the treatment of patients with real world coronary artery
lesions.
Study Design:
Real world, Non randomized, multi centric study. One hundred patients were enrolled.
Study Objective:
The primary objective of this study is to assess the safety and efficacy of the Supralimus
®
Sirolimus
Eluting Stent in
real world coronary artery lesions
Status:
Ongoing
*
Published in EuroIntervention May 2008
Baseline Patient Characteristics (n=100)
Variable
(%)
Diabetes Mellitus
29%
Hypertension
57%
Hyperlipidaemia
38%
Smoker
22%
Previous Myocardial Infarction
56%
Heart failure
7%
Previous PCI
6%
Lesion Characteristics (n=126)
Variable
Chronic occlusion
17 (12%)
In stent restenosis
1 (1%)
Ostial lesion
8 (5%)
Bifurcation
5 (3%)
Major adverse clinical events (n=100)
Variables
1 Month
6 Months
9 Months
24 Months
30 Months
Death (%)
0
1
2
3
3
Non-fatal Myocardial Infarction (%)
0
0
0
0
0
Death or nonfatal MI (%)
0
1
2
3
3
TVR (%)
0
2
4
4
4
Death or nonfatal MI or TVR (%)
0
3
6
7
7
Freedom from MACE (%)
100
97
94
93
93
Quantitative coronary angiographic analysis (n=59)
Baseline
Post-procedure
6 months
Reference vessel diameter, mm
In stent
2.66 ± 0.62
2.86 ± 0.45
2.85 ± 0.46
In segment
2.80 ± 0.47
2.77 ± 0.48
Minimum lumen diameter, mm
In stent
0.73 ± 0.61
2.53 ± 0.43
2.44 ± 0.48
In segment
2.14 ± 0.49
2.11 ± 0.51
Late loss, mm
In stent
0.09 ± 0.28
In segment
0.02 ± 0.37
Diameter stenosis, %
In stent
72.4 ± 21.7
11.5 ± 6.6
14.2 ± 9.9
In segment
24.0 ± 9.3
23.9 ± 12.7
Binary angiographic restenosis, n (%)
In stent
0 (0)
In segment
1 (1.7)
Reference vessel area, mm
2
In stent
5.85 ± 2.78
7.05 ± 3.41
6.84 ± 2.83
In segment
6.41 ± 2.54
6.51 ± 2.42
Minimum lumen area, mm
2
In stent
0.91 ± 1.08
6.24 ± 2.99
5.63 ± 2.67
In segment
4.28 ± 2.45
4.30 ± 2.24
Area stenosis, %
In stent
84.4 ± 15.9
10.1 ± 21.8
18.0 ± 19.8
In segment
34.0 ± 20.5
34.8 ± 20.7
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Last Update: 2008/05/14