Celosia Covered Stent Clinical Study Report Paraguay - Part 2 of 4 - Pages 53-86

Title: Single-Center Non-Randomized Clinical
Evaluation of the Safety, Reliability and Efficacy of

the Celosia Covered Stent in Patients with
Severe Coronary Occlusions
16.3
INDIVIDUAL CLINICAL PROCEDURE REPORTS
CASE 1
CASE SUMMARY
Patient with severe 88% stenotic occlusion in the right coronary artery. Stenting was performed using a Celosia
Covered Stent without previous dilation using balloon angioplasty. Post-procedural vessel patency confirmed.
CASE DETAILS
55 years of age male patient with family history of CAD and hypertension. Previous documented myocardial infarction. No
surgical, interventional, or endovascular procedures performed prior to the study. Diagnostic QCA revealed severe
stenotic lesion in the right coronary artery. Patient admitted the same day of the procedure with previous signed consent
of the trial.
Principal Investigator: Dr. Adrian Ebner. Study Coordinator: Dr. Santiago Gallo. Hospital Name: Sanatorio Italiano.
Asuncion, Paraguay.
PHYSICAL EXAMINATION
Weight: 93kg, Height: 160cm, Blood pressure: 140/80, HR: 61/min. Normal chest auscultation: no murmurs, sinus rhythm,
normal lungs auscultation.
RELEVANT TESTS AND TREATMENT PRIOR TO CATHETERIZATION
LABORATORY TESTS (METABOLIC AND CHEMISTRY/HEMATOLOGY)
BUN: 32mg/dl, Sodium NA: 147mEq/L, Potassium K: 4.2mEq/L, Chloride CL: 103mEq/L, Calcium CA: 1.21mmol/L,
Creatinine: 0.97 mg/dl, Glucose GL: 75mg/dl.
Hemoglobin HGB: 14.2g%, Hematocrit: 43%, Platelets: 182,000/mm, Part Thrombin Time PPT: 33.9s, Thrombin TTIME:
77.5%, Fibrinogen FBGN: 306mg/dl.
PHARMACOLOGICAL TREATMENT
ASA 125mg, Carvedilol 6.25mg bid, Iopamidol (contrast agent): 150cc.
DIAGNOSIS CHARACTERIZATION
Patient presented severe 88% lesion in the right coronary artery (Figure 1). QCA of the left main coronary artery showed
no occlusions. Left anterior descending was of medium caliber with no significant stenotic lesions; diagonal branches with
no lesions. Circumflex artery of medium caliber, non-dominant with ostium lesion of 50% with good distal patency;
marginal arteries of good caliber and with no lesions. Dominant right coronary artery of good caliber with 89% stenotic
lesion in the third segment with good patency in the distal section. Occlusion was 1.0mm with length of 12.7mm.
Figure 1. Severe 88% lesion in the third segment of the right coronary.
INTERVENTIONAL STRATEGY
InSitu Technologies, Inc.
Celosia Covered Stent Clinical Study Report 2015
Page 53 of 80

Puncture of the right common femoral artery with a 6F introducer. Using a JR guide catheter (6F) and a 0.014
guidewire, stenting with no pre-dilation was performed with a 3.0 x 13mm Celosia Covered Stent in the distal right
coronary artery. Stent delivery system tracked with ease into the lesion site and expanded at 14atm for 30 seconds. Postdilation performed to ensure stent securement onto the lumen of the vessel with no angiographic evidence of balloon
rupture or vessel dissection.
FINAL RESULTS
Lesion in target vessel was able to be accessed with stent delivery system; balloon marker bands confirmed to be visible
under fluoroscopy. Stent adequately and successfully deployed at target location; retraction of delivery system confirmed.
QCA shows no lesion residual and TIMI flow evaluation is normal. Post-procedure diameter was 2.57mm with a stenotic
percent improvement of 64%.
Figure 2. 64% stenotic improvement post-implantation of the Celosia Covered stent in the right coronary artery.
CONCLUSIONS
Device was able to cross the stenotic lesion site without the need to pre-dilate. Ischemic cardiopathy with severe lesion in
the third segment of the right coronary successfully treated with Celosia Covered Stent.

Page 54 of 80
CATH Lab/HOsPital:1
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ral
Patient I.D:I
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ONE MONTH FOLLOW-UP

PROCEDURE
DATE OF IMPLANT:
14- _ 04
~mPtomatic
FINAL RESUL T
_10 \S
Date of FOI!OW-up:1\8,_ Q)S'_ \
at one month
Stable angina at one month
Type:
Unstable angina at one month
Type:
------
-----Type:
Vessel:------
Documented silent ischemia at one month
Myocardial infarction
Repeat revascularization before discharge
Death
Signature:1
SIX MONTH FOLLOW-UP

PROCEDURE
DATE OF IMPLANT:
FINAL RESUL T
Date of FOI!OW-up:1
Asymptomatic at six months
Stable angina at six months

Unstable angina at six months
Type:
Type:
Documented silent ischemia at six months
-----------
Myocardial infarction between three and six months

Repeat revascularization between three and six months
Death between three and six months
Signature:!
F7535 (Rev. B)
Ref. QS753 02/25/2010
Type:
Date:1
MASTER
(when in Red'

CASE 2
CASE SUMMARY
Patient with severe 63% stenotic occlusion in the proximal segment of the first marginal branch of the circumflex coronary
artery; first stent implanted missed the lesion proximally, so a second stent was successfully deployed overlapping the
first to relieve the stenotic obstruction. Left anterior descending artery presented 98% severe proximal lesion. Stenting
was performed using Celosia Covered Stents without previous dilation using balloon angioplasty in both cases. Postprocedural vessel patency confirmed.
CASE DETAILS
61 years of age male patient with hypertension and diabetes, as well as family history of CAD. No surgical, interventional,
or endovascular procedures performed prior to the study. Diagnostic QCA revealed severe stenotic lesion in the first
marginal branch of the circumflex artery. Patient admitted the same day of the procedure with previous signed consent of
the trial.
Asuncion, Paraguay.
89.2%, Fibrinogen FBGN: 306mg/dl.
ASA 125mg, Clopidogrel 75mg, Iopamidol (contrast agent): 150cc.
Patient presented no lesions in neither the right coronary artery nor the left main coronary artery. Left anterior descending
of medium caliber with 98% severe proximal lesion of length 6.78mm and 0.32mm with good distal patency; diagonal
branches showed no significant stenotic lesions. Dominant circumflex artery of medium caliber, with no significant stenotic
lesions; first marginal branch of good caliber with 63% stenotic lesion of 3.28mm in length and 0.78mm in the proximal
segment; good distal patency.
A

Page 55 of 80

Figure 1. (A) Severe 98% lesion in the proximal left anterior descending. (B) Severe 63% stenotic lesion in the
first marginal branch of the circumflex artery.
Puncture of the right common femoral artery with a 6F introducer. Using an Extraback guide catheter (6F) and a 0.014
guidewire, stenting with no pre-dilation of the proximal LAD with a .0 x 1 mm Celosia Covered Stent was successfully
performed. Stent delivery system tracked with ease into the lesion site and expanded at 14atm for 30 seconds. Postdilation performed to ensure stent securement onto the lumen of the vessel with no angiographic evidence of balloon
rupture or vessel dissection.
Stenting of the first marginal LCX was performed with a 2. x 1 Celosia Covered Stent. At the moment of balloon
inflation implant missed the bulk of the stenotic lesion proximally. A second Celosia Covered Stent (2. x 16mm) was
then tracked past the distal end of the implanted stent and deployed at 14atm for 30 seconds to overlap 2mm inside the
first stent. Successful implant was confirmed by QCA with no angiographic evidence of overlapping stents migration or
vessel dissection.
FINAL RESULTS
Lesions in target vessel were able to be accessed with stent delivery system; balloon marker bands confirmed to be
visible under fluoroscopy. Implant in the proximal LAD adequately and successfully deployed at target location; retraction
of delivery system confirmed. Successful implant of 2 overlapping stents in the marginal branch of the LCX confirmed in
angiography. In both cases, QCA shows no lesion residual and TIMI flow evaluation is normal. Post-procedure diameter
was 1.80mm with a stenotic percent improvement of 51% in the proximal LAD, and 1.97mm with a stenotic percent
improvement of 42% in the marginal LCX (Figure 2).
A
Figure 2. (A) Post-procedure 1% stenotic improvement with the Celosia Covered Stent in the proximal LAD. (B) Postprocedure 42% stenotic improvement in the first marginal branch of the LCX with 2 overlapping Celosia Covered
Stents.
CONCLUSIONS
In both cases, device was able to cross stenotic lesion sites without the need to pre-dilate. Ischemic cardiopathy with
severe lesion in the proximal LAD and first marginal LCX were successfully treated with Celosia Covered Stents. Stents
proved to be able to deploy overlapping without the risk of stent migration or vessel dissection.

Page 56 of 80
CATH Lab/l-lospital.l
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Patient 1.0:1
I LOT#:1
ONE MONTH FOLLOW-UP

PROCEDURE
DATE OF IMPLANT:
1"\_
FINAL RESULT
04 _'Lo \ S
mptomatiC
A. ~
at ono month
Stable angina at one month
Type:
Unstable angina at one month
Type:
Documented silent ischemia at one month
Myocardial infarction
Repeat revascularization before discharge
------
-----Type:
Vessel:------
Oeath
Sgnature:1
SIX MONTH FOLLOW-UP

PROCEDURE
DATE OF IMPLANT:
FINAL RESULT
r Asymptomatic
Date of FOIIOW-up:1
at six months
Stable angina at six months
Type:
r Unstable angina at six months
Type:
r Oocumented silent ischemia at six months
Type:
-----------
r Myocardial infarction between three and six months

r Repeat revascularization
between three and six months
Oeath between three and six months
Signature:1
F7535 (Rev. B)
Ret. QS753 02/25/2010
oate:1
MASTER (when in Red

CASE 3
CASE SUMMARY
Patient with severe 74% stenotic occlusion in the medial left anterior descending coronary artery; challenging case
because of patients tortuous vasculature. Stenting was performed using a Celosia Covered Stent without previous
dilation using balloon angioplasty. Post-procedural vessel patency confirmed.
CASE DETAILS
72 years of age female patient with hypertension; no family history of CAD. No surgical, interventional, or endovascular
procedures performed prior to the study. Patient presented a severe case of kyphoscoliosis and spondylosis which made
the tracking in the descending aorta challenging. Diagnostic QCA revealed severe stenotic lesion in the mid-section of the
left anterior descending coronary artery. Patient admitted the same day of the procedure with previous signed consent of
the trial.
Asuncion, Paraguay.
90%, Fibrinogen FBGN: 301mg/dl.
ASA 125mg, Carvedilol 25mg bid, Clopidogrel 75mg, Iopamidol (contrast agent): 150cc.
Patient presented no lesions in neither the right coronary artery nor the main left coronary artery. The left anterior
descending artery was of good caliber with a 74% stenotic lesion with length of 7.90mm and 0.72mm in the medial
section; no lesions in the diagonal branches (Figure 1). The circumflex artery was dominant of good caliber with no
lesions; the second marginal branch was thin with 95% distal stenotic lesion.
Figure 1. Severe 74% lesion in the mid-section of the LAD.
Puncture of the right common femoral artery with a 6F introducer. Using an Extraback guide catheter (6F) and a 0.014
guidewire, stenting with no pre-dilation was performed with a 2. x 16mm Celosia Covered Stent in the medial LAD.
Stent delivery system tracked with ease up the descending aorta despite tortuous vasculature and into the lesion site.
Stent expanded at 14atm for 30 seconds. Post-dilation performed to ensure stent securement onto the lumen of the
vessel with no angiographic evidence of balloon rupture or vessel dissection.
Page 57 of 80

FINAL RESULTS
Lesion in target vessel was able to be accessed with stent delivery system; balloon marker bands confirmed to be visible
under fluoroscopy. Stent adequately and successfully deployed at target location; retraction of delivery system confirmed.
QCA shows no lesion residual and TIMI flow evaluation is normal. Post-procedure diameter of the medial LAD was
3.15mm with a stenotic percent improvement of 57.26% (Figure 2).
Figure 2. 57% stenotic improvement post-implantation of the Celosia Covered stent in the medial LAD.
CONCLUSIONS
Device was able to track past the tortuous descending aorta and across the stenotic lesion site without the need to predilate. Ischemic cardiopathy with severe lesion in the medial left anterior descending artery successfully treated with
Celosia Covered Stent.

Page 58 of 80
CATH Lab/Hospitat.
'1
patientI.D:I.
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~3ILoT#r\1.
ONE MONTH FOLLOW-UP

PROCEDURE
DATE OF IMPLANT:
FINAL RESUL T
I~_ 0'-\ _'lo \~
jSymPIOmatiC
Date of FOllow-up:1\~~ (Ql~_
S.
al one monlh
r Stable angina at one month

r Unstable angina at one month
r Documented
\\
Type:
Type:
------
Type:
Vessel:------
silent ischemia at one month
r Myocardial infarction
)r Repeat revascularization
------
before discharge
r Death
Signature:1
Date:l
1/ (/IJ-
SIX MONTH FOLLOW-UP

PROCEDURE
DATE OF IMPLANT:
FINAL RESUL T
r Asymptomatic
Date of FOIIOW-up:1
at six months
r Stable angina at six months
Type:
r Unstable angina at six months

r Documented silent ischemia at six months
Type:
Type:
-----------
r Myocardial infarction between three and six months
r Repeat revascularization between three and six months

r Death between three and six months
Signature:1
F7535 (Rev, B)
Ref. QS753 02/25/2010
Date:1
MASTER !when in Red\

Celosia Covered Stent Clinical Study Report Paraguay - Part 2 of 4 - Pages 53-86

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Title: Single-Center Non-Randomized Clinical

Evaluation of the Safety, Reliability and Efficacy of

INDIVIDUAL CLINICAL PROCEDURE REPORTS

Title: Single-Center Non-Randomized Clinical

InSitu Technologies, Inc.

ONE MONTH FOLLOW-UP

Date of FOI!OW-up:1\8,_ Q)S'_ \

Stable angina at one month

Unstable angina at one month

Documented silent ischemia at one month

SIX MONTH FOLLOW-UP

Asymptomatic at six months

Stable angina at six months

Documented silent ischemia at six months

Myocardial infarction between three and six months

Title: Single-Center Non-Randomized Clinical

InSitu Technologies, Inc.

Title: Single-Center Non-Randomized Clinical

InSitu Technologies, Inc.

ONE MONTH FOLLOW-UP

Stable angina at one month

Unstable angina at one month

Documented silent ischemia at one month

Repeat revascularization before discharge

SIX MONTH FOLLOW-UP

Stable angina at six months

r Unstable angina at six months

r Oocumented silent ischemia at six months

r Myocardial infarction between three and six months

between three and six months

Oeath between three and six months

MASTER (when in Red

Title: Single-Center Non-Randomized Clinical

Figure 1. Severe 74% lesion in the mid-section of the LAD.

Title: Single-Center Non-Randomized Clinical

InSitu Technologies, Inc.

ONE MONTH FOLLOW-UP

I~_ 0'-\ _'lo \~

Date of FOllow-up:1\~~ (Ql~_

r Stable angina at one month

silent ischemia at one month

SIX MONTH FOLLOW-UP

r Stable angina at six months

r Unstable angina at six months

r Myocardial infarction between three and six months

r Repeat revascularization between three and six months

MASTER !when in Red\

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