AngioScore AngioSculpt RX Instructions For Use Manual page 4

VI. COMPLICATIONS
Possible complications include, but are not limited to, those listed in
Table 1 below:
Table 1: Possible Complications
• Death
• Heart Attack (acute myocardial infarction)
• Total occlusion of the treated coronary artery
• Coronary artery dissection, perforation, rupture,
or injury
• Pericardial tamponade
• No/slow reflow of treated vessel
• Emergency coronary artery bypass (CABG)
• Emergency percutaneous coronary intervention
• CVA/stroke
• Pseudoaneurysm
• Restenosis of the dilated vessel
• Unstable chest pain (angina)
• Thrombo-embolism or retained device components
• Irregular heart rhythm (arrhythmias, including life-
threatening ventricular fibrillation)
• Severe low (hypotension)/high (hypertension) blood
pressure
• Coronary artery spasm
• Hemorrhage or hematoma
• Need for blood transfusion
• Surgical repair of vascular access site
• Creation of a pathway for blood flow between the
artery and the vein in the groin (arteriovenous
fistula)
• Drug reactions, allergic reactions to x-ray dye
(contrast medium)
• Infection
VII. SUMMARY OF CLINICAL STUDIES
Study Design
A multi-center, non-randomized, single-arm, prospective clinical study
was conducted to evaluate the safety and efficacy of the AngioSculpt
catheter in a wide range of coronary artery lesions in native vessels and
following in-stent restenosis. The study population was adult patients
scheduled to undergo clinically indicated percutaneous coronary
intervention. Following informed consent, 45 patients meeting the
study inclusion criteria underwent treatment with the AngioSculpt
catheter.
Patient Selection
The following key inclusion criteria were utilized for patient selection:
• Planning to undergo clinically indicated percutaneous coronary
intervention in native coronary arteries including in-stent restenosis
• Target lesion reference vessel size 2.0 – 4.0 mm diameter
• Target lesion length ≤ 30mm
• Target lesion severity ≥ 60% diameter stenosis
Patients meeting the above criteria were to be excluded for any of the
following reasons:
• Target lesion in left main coronary artery
• Target lesion in degenerated saphenous vein graft
• Target lesion in a severe angulation of >60 degrees
• Target lesion distal to freshly deployed stent
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• Target lesion demonstrating major dissection prior to deployment of
AngioSculpt catheter
• Visible thrombus (by angiography) at target lesion site
Objectives
The primary safety objective was to demonstrate the incidence and
severity of device-related complications (MACE: death, Q wave/non-Q
wave MI, TLR) at one month follow-up.
The primary performance objective was to demonstrate successful
percutaneous revascularization (defined as a reduction in target lesion
diameter stenosis to ≤ 50% following completion of all interventions
and the absence of in-hospital MACE).
Methods
Patients were treated in standard fashion and according to institutional
practice for percutaneous coronary interventions including the
use of anti-coagulants (e.g. heparin) and antiplatelet agents (ASA,
clopidogrel). There was no attempt to alter standard practice for these
study patients other than using the investigational device.
Coronary angiography in the views best demonstrating the target
lesion was performed prior to device deployment. When technically
possible, IVUS of the target lesion was performed prior to device
deployment at one of the two clinical sites.
A cineangiogram was taken of the deployed device immediately prior
to and during inflation. Coronary angiography of the target lesion
following completion of each device treatment (and prior to adjunctive
stent placement) was performed in the original views. IVUS of the
target lesion was performed following device treatment (and prior to
adjunctive stent placement).
Additional clinically indicated interventions (e.g. stent placement) were
performed and coronary angiography of the target lesion following
completion of all interventions was performed in the original views.
Post-intervention medication was administered according to
institutional protocol for percutaneous coronary interventions
involving stents. EKG was recorded immediately post-procedure and at
24 hours or pre-discharge (whichever was earlier). CPK (and Troponin-I
if CPK is abnormally elevated), at 4 and 12 hours post-procedure and at
24 hours/pre-discharge (whichever was earlier) were recorded.
Patients treated with the AngioSculpt catheter underwent a follow
up examination 14-28 days from the interventional procedure which
consisted of an office visit or telephone questionnaire for assessment
of vital status, post-discharge myocardial infarction, post-discharge
CABG surgery/PCI, angina class, and an EKG assessment.
Results
Following informed consent, 45 consecutive patients (age 63±10.7
years, males 69%) referred for percutaneous coronary intervention
and meeting the study inclusion criteria underwent treatment with
the AngioSculpt catheter. The age and gender of the patients studied
reflect the typical distribution in non-selected patients referred for
percutaneous coronary intervention.
Patients were treated with standard peri-procedural medications
including aspirin, clopidogrel, intravenous heparin and glycoprotein
2b/3a inhibitors at the discretion of the investigator.
All patients were available and underwent clinical follow-up at
14-28 days following treatment with the AngioSculpt catheter.
The AngioSculpt catheter was utilized in 45 patients and a total of
46 lesions. Of these 46 lesions, 32 were in native vessels and 14 were
in-stent restenosis (ISR). The AngioSculpt was used as a standalone
treatment in 10 lesions (9 ISR and 1 native vessel) and was used in
combination with stenting in the remaining 36 lesions. In these
cases, the AngioSculpt was intentionally undersized relative to the
reference vessel diameter in order to facilitate stent placement
(i.e. "pre-dilation").
There were no device-related major adverse clinical events (MACE: death,
Q wave or non-Q wave myocardial infarction, ischemia driven target
lesion revascularization) encountered during hospitalization or during
the follow-up period (24.8±8.5 days). There were no device-related
coronary artery perforations. There were no device malfunctions.
PN-3078-0001 Rev. C 01/13