Arterial Occlusive Diseases Clinical Trial
Official title:
Safety and Effectiveness of ByCross Rotational and Aspiration Device for Revascularization of Total or Sub-total Occluded Peripheral Arterial Vessels of Luminal Diameter Equal to or Larger Than 3mm: A Prospective, Multi-center Study
The aim of the study is to demonstrate safety and effectiveness of ByCross Rotational and
Aspiration device used for revascularization of total or sub-total occluded peripheral
arterial vessels equal to or larger than 3mm in diameter.
The ByCross is a single use, disposable, minimal invasive aspiration rotational atherectomy
device. The ByCross is aimed to enable effective revascularization and restore blood flow in
peripheral occluded vessels. In cases that the artery is completely blocked such that opening
is not possible with currently available solutions and the procedure cannot be completed, the
device is capable of crossing the blocked lesion without guiding wire and enables the
completion of the procedure in a safe and effective manner, thus potentially eliminating the
need for open bypass surgery. The ByCross can be used in several pathologies: calcified
atheroma, old and fresh thrombus.
Eligible adult patients with symptoms due to chronic sub-total and total occlusion will be
enrolled and undergo percutaneous procedure including use of ByCross which will normally be
followed by balloon inflation (Percutaneous Transluminal Angioplasty) in the artery at
location where blockage has been opened by ByCross to further open the artery and restore
full opening, and in some case followed by placement of a stent for long term stabilization.
For demonstrating safety and effectiveness up to 42 patients will be enrolled. the procedure
will take up to 2 hours followed by up to 48 hour hospitalization. Patients will then come
for follow-up monitoring and examination 30 days and 6 months after procedure. Although this
is unlikely, in some cases the physician can decide during procedure that following ByCross
opening of the artery, ballooning or stent is not required. In this case the patient will
come for another follow-up visit after 12 month.
Occlusive vascular disease (OVD) is the leading cause of mortality and morbidity in the
Western world. Arterial obstructions generally start as a build-up of harder atherosclerotic
material on which clotted blood (thrombus) forms, whereas veins obstruction contains mostly
thrombus. Over 10 million patients in the US suffer from peripheral arterial disease (PAD)
including 750,000 critical limb ischemia patients who are at risk of limb amputation.
The existing pharmacological and bypass surgical methods to treat OVD are risky, expensive,
and time-consuming. Overcoming these shortcomings presents a substantial opportunity for a
mechanical catheter. Atherectomy with mechanical catheters has been used clinically for many
years, and by now the clinical outcome of atherectomy is known as reflected by multiple
clinical studies. The potential benefit of the technique compared with percutaneous
transluminal angioplasty (PTA) and/or Stenting alone or as an adjunctive therapy has also
been discussed, and more recently as an adjunctive prior to PTA with a drugeluting balloon
and stenting. The existing catheters designed mainly for arteries are expensive, complicated
to operate, demonstrate limited reduction in level of stenosis, might cause perforations,
distal embolization and hemolysis, have no or poor aspiration, and cannot cross occlusions
without passage of guidewire first. Despite the common use of these therapies and current
benefits, there remain significant opportunities to extend catheter-based treatments with
improved outcomes, to more patients and at lower cost.
The ByCross is a minimal invasive, single use atherectomy and thrombectomy device, which is
introduced over the wire into the peripheral vasculature for revascularization of chronic
occluded peripheral vessels. The ByCross has a coaxial flexible rotating shaft with an
expandable tip and integrates an independent aspiration system for suction of thrombotic
material. The expandable tip is an elastic arc that can bow and enlarge the tip diameter from
external tip diameter of 1.7mm at closed condition to 4.7mm at open condition. As the shaft
rotates, the tip breaks the calcified atheroma or thrombus into small particles, which are
simultaneously aspired into the shaft and removed into the attached collection bag. The
ByCross allows injection of contrast medium and thrombolytic agents through the rotating tip
during the procedure for continuance imaging and prevention of appositional thrombus
formation. Due to its no-symmetrical helical design the tip rotation is eccentric, causing
the tip to recenter is self within the lumen as it rotates. While ByCross is introduced over
a guide wire, it does not require the passage of an occlusion with the wire first. To cross
the occlusion the ByCross is advanced with running motor forth and back in a closed
condition. Once the occluded segment is crossed the procedure is repeated with open tip at
larger diameter vessels to further remove the remaining atheroma or thrombus. The ByCross is
battery powered, and includes a remote-control unit which allows the user full ergonomic
control of the device next to the puncture site.
Based on compliance with standard requirements, design process and risk analysis process. The
risk of occurrence of adverse events is not expected to be greater than the risk reported for
other devices available in the market today. More over the past animal test supports the
expected low risk. This study, aside to performance investigation, is intended to validate
this. The potential significant advantage of the ByCross device in the treatment of chronic
limb ischemia is the ability to cross Chronic Total Occlusion (calcified atheroma and/or
thrombus, in oppose to other atherectomy devices which can only cross partial occluded vessel
due to the necessity of progressing over the wire). Thus, instead of aborting the procedure,
completion of revascularization procedure percutaneously is possible. In addition, the
ByCross enables, due to its design, to achieve superior patency, injection of contrast medium
and antiplatelet during operation of the radio-opaque tip, and enables simultaneous
aspiration.
These benefits potentially reduce prolonged percutaneous procedures if other means are
required to enable chroni total occlusion (CTO) passage by guidewire, and, might, in the
future, reduce the number of bypass surgeries in peripheral arteries, all with no risk
compared to long term clinical use of equivalent devices.
Information gathered in this study will further assure the ByCross device as superior
solution enabling more beneficial minimal invasive procedure for the subjects with the same
indication for treatment.
The study is multi-center, single arm, open label, prospective study. 42 patients with total
or subtotal occlusion at target vessel bearing length equal to or larger than 3cm at vessels
diameter of 3mm or larger will be enrolled to the study. Eligible consented subjects will
undergo a procedure and treated with the ByCross device. Additional adjunctive treatment
(such as PTA, stenting etc.) may be performed per physician's discretion and according to
standard of care. Assessment of device safety and performance will be performed intra and
post procedural, at discharge, at 30 days post procedure and at 6 months. Subjects that will
undergo procedure using ByCross only with NO adjunctive therapy will be followed-up at 12
months as well. The overall duration of participation for each subject is expected to be up
to 7 months and 13 months for those that undergo procedure using ByCross only.
Primary outcome measures are divided into two: performance and safety. The null hypotheses
will be tested via the lower limit of the one-sided 95% exact confidence interval for the
respective proportions. The expected Acute Procedural Success rate is 95% as is the rate of
subjects free of device-related Major Adverse Events (MAEs) throughout a 30-day follow-up.
The sample size required to achieve a lower one-sided 95% exact confidence limit that is
greater than 85%, if the point estimate of the proportion is 95%, is calculated as 40
patients. To accommodate a potential 5% drop-out prior to completing 30 days follow-up, up to
42 patients may be required to be enrolled.
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