1. RevElution Clinical Trial
Baseline Demographics
Subjects ( N = 6) 1 2 3 4 5 6
Patient Demographics
Age (n) 78 65 70 72 74 60
Gender (M/F) F M
Diabetes (Y/N) Y N
Y (ID)
Hypertension (Y/N)
Hyperlipidemia (Y/N)
Prior MI (Y/N)
Prior PCI (Y/N)
Procedural Characteristics
Access Route TR
Lesions treated (n)
Diameter stenosis (%)
95/90 75 95 90
RVD (mm)
3.0/3.5
3.5
3.0
2.9
Lesion Length (mm)
13/8 10 14 15 16
Pre-Dilatation Performed (Y/N)
Stents Implanted (n)
1/1
Daniel Chamié, MD Interventional Cardiologist, Institute Dante Pazzanese of Cardiology Director, OCT Core Laboratory, Cardiovascular Research Center Sao Paulo, Brazil

2. RevElution Clinical Trial
OCT Results – Cross Section Level
1 Month Follow Up
N = 6 patients
N = 7 lesions
N = 8 stents
Analyzed Stent Length, mm
21.66 ± 9.41
Total number of analyzed cross-sections
258
Cross-Sections Analyzed Per Scaffold
36.86 ± 16.12
Mean reference lumen area, mm2
7.43 ± 1.69
Mean reference lumen diameter, mm
3.24 ± 0.44
Daniel Chamié, MD Interventional Cardiologist, Institute Dante Pazzanese of Cardiology Director, OCT Core Laboratory, Cardiovascular Research Center Sao Paulo, Brazil

3. RevElution Clinical Trial
OCT Results – Cross Section Level
Post-Procedure
N = 5 patients
N = 6 lesions
N = 7 stents
1 Month Follow Up
N = 6 patients
N = 7 lesions
N = 8 stents
P-value
Stent Analysis
Mean Stent Area, mm2
9.07 ± 1.54
8.73 ± 1.68
0.652
Mean stent diameter, mm
3.38 ± 0.29
3.32 ± 0.31
0.564
Lumen Analysis
Minimum Lumen Area, mm2
7.22 ± 1.67
6.62 ± 1.65
0.389
Incomplete Stent Apposition (ISA) Quantification
No. of Lesions with ISA, n (%)
6/6 (100%)
4/7 (57.14%)
---
Mean ISA Area, mm2
0.57 ± 0.29
0.88 ± 0.49
0.230
Mean ISA Volume, mm3
3.65 ± 3.96
3.17 ± 3.39
0.112
Acute Plaque Prolapse Quantification
Plaque Prolapse Area, mm2
0.27 ± 0.06
Plaque Prolapse Volume, mm3
6.22 ± 2.55
Neointimal Hyperplasia (NIH) Quantification
Mean NIH Area, mm2
0.49 ± 0.18
Mean NIH Volume, mm3
10.86 ± 5.99
Mean NIH Obstruction, %
5.82 ± 2.18
Daniel Chamié, MD Interventional Cardiologist, Institute Dante Pazzanese of Cardiology Director, OCT Core Laboratory, Cardiovascular Research Center Sao Paulo, Brazil

4. RevElution Clinical Trial OCT Results – Strut level
Post-Procedure
N = 5 patients
N = 6 lesions
N = 7 stents
1 Month Follow Up
N = 6 patients
N = 7 lesions
N = 8 stents
P-value
Total number of analyzed struts
2,891
3,099
Frequency of covered struts per lesion, %
---
89.84 ± 5.06
N/A
Frequency of malapposed struts per lesion, %
4.85 ± 2.99
2.03 ± 2.73
0.002
Mean NIH thickness over covered struts, mm
0.06 ± 0.02
Daniel Chamié, MD Interventional Cardiologist, Institute Dante Pazzanese of Cardiology Director, OCT Core Laboratory, Cardiovascular Research Center Sao Paulo, Brazil

5. RevElution Clinical Trial
OCT Results – 1 Month Follow Up
Frequency (%) per lesion
0.06
Daniel Chamié, MD Interventional Cardiologist, Institute Dante Pazzanese of Cardiology Director, OCT Core Laboratory, Cardiovascular Research Center Sao Paulo, Brazil

6. Frequency of Covered Struts per Lesion (%)
RevElution Clinical Trial
Frequency of Covered Struts Per Lesion
Frequency of Covered Struts per Lesion (%)
1Circulation. 2007;115:
In a stent with 30% uncovered struts (70% covered), the odds ratio for thrombus is 9.0 (95% CI, 3.5 to 22.0) compared with a stent with complete coverage1
A univariable logistic GEE model of occurrence of thrombus in a stent section versus RUTSS shows that there is a considerable elevation of risk of thrombus as the RUTSS increases.1
(RUTSS) = variable ratio of uncovered to total struts per section
Daniel Chamié, MD Interventional Cardiologist, Institute Dante Pazzanese of Cardiology Director, OCT Core Laboratory, Cardiovascular Research Center Sao Paulo, Brazil

7. Case 20001-002 Smooth circular NIH Post-Procedure 1-Month Follow-up
Age (n) 65
Gender (M/F) M
Diabetes (Y/N) Y
Hypertension (Y/N)
Diameter stenosis (%) 75
RVD (mm)
3.5
Lesion Length (mm) 10
Pre-Dilatation Performed (Y/N) Y
Stents Implanted (n) 1
Post-Procedure
1-Month Follow-up
0.6 mm
2 mm
8 mm
10 mm
18 mm
Smooth circular NIH
Daniel Chamié, MD Interventional Cardiologist, Institute Dante Pazzanese of Cardiology Director, OCT Core Laboratory, Cardiovascular Research Center Sao Paulo, Brazil

8. Case 20013-002 Post-Procedure 1-Month Follow-up Age (n) 60
Gender (M/F) F
Diabetes (Y/N)
Y (ID)
Hypertension (Y/N) Y
Diameter stenosis (%) 90
RVD (mm)
3.0
Lesion Length (mm) 16
Pre-Dilatation Performed (Y/N) Y
Stents Implanted (n) 2
Post-Procedure
1-Month Follow-up
0.6 mm
14 mm
17 mm
17.8 mm
42.2 mm
Daniel Chamié, MD Interventional Cardiologist, Institute Dante Pazzanese of Cardiology Director, OCT Core Laboratory, Cardiovascular Research Center Sao Paulo, Brazil

9. Early (1M) Healing of Overlapping Struts
Case
Early (1M) Healing of Overlapping Struts
Daniel Chamié, MD Interventional Cardiologist, Institute Dante Pazzanese of Cardiology Director, OCT Core Laboratory, Cardiovascular Research Center Sao Paulo, Brazil

10. RevElution Clinical Trial
Conclusions
The 1M OCT data from the RevElution Clinical Trial (N = 6 patients; 8 stents) demonstrates an early healing profile with high rates of strut coverage of approx. 90% at 1 month.
Additionally, the data also show a high efficacy profile as attested by low NIH formation.
The low malapposition seen post-procedure was effectively halved within 1 month giving evidence to rapid healing
At 1 M the NIH area was 0.49 mm2, percent obstruction 5.82% and NIH thickness: 0.06mm
Additional datasets at later timepoints will provide valuable information to further confirm these early results.