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 1.
Background |
| The Classic NM PTCA
dilatation catheters produced by Neich Medical
(Shenzhen) Co. Ltd. were clinically evaluated
in Fu Wai Hospital. The clinical evaluation
was performed according to the agreement and
clinical protocol signed between this hospital
and Neich Medical. The clinical evaluation
was conducted by the experienced staff of
our cardiovascular institute. |
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| 2.
Clinical Investigators |
| Director |
Professor
Gao Run Lin
Director of Cardiovascular Institute
and Fu Wai Hospital |
| Participants |
Professor Chen Ji
Lin
Professor Yang Yue Jin
Professor Qin Xue Wen
Professor Yao Min
Associate Professor Wu Yong Jian
Associate Professor Liu Hai Bo |
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| 3.
Products Evaluated |
| Catalog
Number |
Quantity
Evaluated |
Balloon
Length
(mm) |
Inflated
balloon
Diameter (+5%) |
100
- 2020 |
1 |
20 |
2.0 |
100
- 2520 |
24 |
20 |
2.5 |
100
- 3020 |
6 |
20 |
3.0 |
100
- 3520 |
1 |
20 |
35 |
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| 4.
Clinical Evaluation Data |
| 4.1 |
Patients |
| 4.1.1 |
Total 30 patients |
| 4.1.2 |
Male: 24
Female: 6 |
| 4.1.3 |
Age less than 50 : 6
Age 50-60 : 5
Age 60-70 : 15 Age
70-80 : 4 |
| 4.1.4 |
Lesions Treated |
| 4.2.1 |
| Location of lesion:
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| RCA ostial 0 case; |
RCA proximal 3 cases; |
| RCA mid 6 cases; |
RCA distal 1 case |
| LAD ostial 2 case; |
LAD proximal 8 cases; |
| LAD mid 10 cases; |
LAD distal 0 case |
| LCX ostial 0 case; |
LCX proximal 7 cases; |
| LCX mid 3 cases; |
LCX distal 0 case |
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| 4.2.2 |
Calcified lesion 4 cases |
| 4.2.3 |
With thrombus 3 cases |
| 4.2.4 |
Tortuosity of blood vessel:
severe 5 cases; moderate
19 cases; mild
16 cases |
| 4.2.5 |
| Classification of
lesion according to ACC: |
| Type A 2 cases;
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Type B1 9 cases;
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| Type B2 18 cases; |
Type C 11 cases |
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| 4.3 |
Angiographic examination:
This evaluation involved 38 blood
vessels and 40 lesions.
Pre-procedure reference diameter of
the blood vessels was 2.5mm--4.0mm,
mean diameter was (3.09 ± 0.39)mm.
Degree of stenosis was 80%--100%,
mean degree of stenosis was (88.35
+ 6.39)%. Pre- procedure degree of
stenosis of the cases were listed
below :
| Degree
of stenosis |
Degree
of stenosis
|
| 80-90%
|
>
90% |
Number of
cases |
32 |
8 |
Percentage
of total cases |
80% |
20% |
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| 4.3.1 |
Procedure:
The patients of the 30 cases were
indicated for elective PTCA and stenting.
There were 24 males (80%) and 6 females
(20%). A total of 38 vessels, 40 lesions
were treated. Among the lesions treated,
there were 18 Type B2 lesions (45%),
11 Type C lesions (27.5%), 9 Type
B1 lesions (22.5%) and 2 Type A lesions
(5%).
29 cases were successful with 39 lesions
successfully treated (97.5%). There
was one unsuccessful case (2.5%).
The reason was the Boston Scientific
‘s PT Graphix guidewire could not
fit the 2.5mm balloon catheter.
Post procedural residual stenosis
was 0% for 14 lesions, 10% for 2 lesions,
20-30% for 14 lesions, > 30% for
9 lesions. The mean residual stenosis
was (18.46+19.13)%. Because the majority
of the cases were for elective stenting,
balloons used were 0.5mm smaller than
the reference diameter of the blood
vessel (for 3.0mm diameter blood vessel
use 2.5mm balloon).
Consequently, the residual stenosis
is greater. There was no intimal dissection,
no acute occlusion, no thrombus formation
or other complication |
| 4.4 |
Complication during the procedure:
0 case |
| 4.5 |
Pre-discharge examination: |
| 4.5.1 |
Wound infection: 0 case |
| 4.5.2 |
Other complication: 0 case
Performance of catheter
| Performance
attribute
|
Performance
Rating
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| Excellent |
Good
|
Fair |
Poor
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Pushability
(cases) (%)
|
12 |
12 |
5 |
2 |
38.7%
|
38.7%
|
16.2% |
6.4% |
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Crossing the
lesion
(cases) (%) |
11 |
18 |
2 |
0 |
35.5% |
58.1% |
6.4%
|
0% |
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Conforming
to the lesion
(cases) (%) |
8 |
21 |
2 |
0 |
25.9% |
67.7% |
6.4%
|
0% |
|
Trackability
(cases) (%) |
10 |
19 |
2 |
0 |
32.3% |
61.3%
|
6.4% |
0% |
The catheter has excellent pushability,
good capability in crossing the lesions,
conforming to the lesions and in tracking
the guidewire. The inflation pressure
used ranged from 6 to 18 atmospheres.
The Classic NM PTCA dilatation catheter
was fundamentally equivalent to the
other companies’ balloon catheter
in clinical performance. |
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| 5.
Analysis of Clinical Evaluation |
| During this clinical
evaluation of Classic NM catheters, 32 units
of catheters were evaluated, 40 lesions in
30 patients were treated with satisfactory
result obtained
The Classic NM catheter has the following
characteristics:
| • |
The design of the catheter
is suitable for use in coronary arteries. |
| • |
The catheter body and its torque control
is good. The balloon can withstand high
pressure. The catheter has excellent
pushability, good capability in crossing
the lesions, conforming to the lesions
and in tracking the guidewire. |
| • |
The catheter is compatible with guiding
catheters, guidewires and other accessories
of the cardiac catheterization lab.
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| • |
The catheter is easy to use, can be
exchanged rapidly, does not require
wire extension, therefore the time of
exposure to X ray is shortened. |
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| 6.
Conclusion |
| After conducting the
clinical evaluation in our hospital, the Classic
NM dilatation catheter from Neich Medical
(Shenzhen ) Co. Ltd. is found to be suitable
for use in PTCA procedures and in predilatation
before coronary stenting. The quality and
performance of this catheter is equivalent
to the other balloon catheters available in
the market. |
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| 7.
Adverse Event |
| 7.1 |
In the entire clinical
evaluation of Classic NM, there was
no adverse event. |
| 7.2 |
Suggested improvement:
Suggest to increase slightly the inner
lumen of the balloon catheter so that
guidewires from all manufacturers can
be passed through easily. |
Clinical Investigator’s signature:
Cardiovascular Institute and Fu Wai Hospital,
Chinese Academy of Medical Sciences |
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