The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross* micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries. The procedure will be conducted on consenting…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Safety Endpoint:
30 day MACE, defined as the composite of death, myocardial infarction (MI), or
urgent revascularization (target vessel revascularization (TVR) or urgent
coronary artery bypass surgery (CABG)).
Primary Effectiveness Endpoint:
Intra-procedural technical success Defined as the ability of the NovaCross*
microcatheter to successfully facilitate placement of a guidewire beyond a
native coronary chronic total occlusion (CTO) in the true vessel lumen.
Secondary outcome
Secondary endpoints:
The following objectives are pre-specified but are not intended to support
product labeling:
1) The ability to cross the lesion with a guidewire in the true lumen,
effectively dilate the CTO lesion, and place a coronary stent with residual
lumen stenosis of less than 30% while restoring antegrade TIMI 3 flow.
2) The ability of the NovaCross* micro-catheter to facilitate a guidewire
successfully penetrating the proximal cap of the CTO.
3) The effectiveness of the extendable portion in intra-CTO microcatheter
crossability.
4) The ability to have full visualization of the NovaCross during the CTO
procedure.
5) Assess the usability of the NovaCross* by the operator.
6) Device-related perforation at the site of target coronary lesion and/or its
proximal reference segment.
Background summary
The purpose of this trial is to evaluate the safety and effectiveness of the
NovaCross* micro-catheter when used to facilitate crossing of Chronic Total
Occlusion (CTO) lesions in coronary arteries. The procedure will be conducted
on consenting patients diagnosed with a CTO in a coronary vessel that requires
revascularization after a previously failed attempt to cross or refractory to
10 minutes of conventional guidewire attempt.
Study objective
The purpose of this trial is to evaluate the safety and effectiveness of the
NovaCross* micro-catheter when used to facilitate crossing of Chronic Total
Occlusion (CTO) lesions in coronary arteries. The procedure will be conducted
on consenting patients diagnosed with a CTO in a coronary vessel that requires
revascularization after a previously failed attempt to cross or refractory to
10 minutes of conventional guidewire attempt.
Study design
This is a prospective, non-randomized, multi-center, pivotal investigational
study, intended to assess the safety and effectiveness, and deployment and
withdrawal characteristics of the NovaCross* micro-catheter during
interventional coronary angioplasty procedures involving efforts to cross
previously refractory CTOs.
Each study subject/patient will have a total of one (1) NovaCross* procedure
performed for this study.
All Data will be collected at baseline, procedure, and 30 days post procedure.
All adverse events will be recorded, and serious adverse events will be
reported in accordance with EC and regulatory requirements.
Intervention
The anterograde approach is the first choice technique in the vast majority of
percutaneous interventions of CTOs. After choosing the adequate guiding
catheter for maximal back-up support, and ensuring good distal vessel
opacification either by ipsilateral circulation or simultaneous contralateral
injection, it is mandatory to select the angiographic projection that best
shows the characteristics of the entrance to the CTO. To monitor the
progression of the guide wire over the microcatheter, an orthogonal view should
be selected and mentally trace the pathway to be followed by the guide wire
from the proximal cap to the distal lumen through the entire occlusion.
Selection of a Guide wire
Guide wire for a true CTO should be selected according to the age and
morphological features of the occlusion. Although there is a great variability
in guide wire selection to start a CTO procedure among experienced operators,
some general recommendations can be made:
* In a true CTO it is unlikely that floppy wires will cross the occlusion.
* Stiff wires should not be advanced through the proximal segment of a CTO,
especially when some tortuosity is present, due to the risk of damaging the
arterial
wall. A floppy wire is the best choice to negotiate the proximal segment to the
CTO and advance an OTW catheter up to the proximal stump and then exchange to a
dedicated stiffer wire.
* Polymeric coated guide wires may be the first choice when intraluminal
microchannels are visible on angiography, and in some angulated and calcified
lesions. Because of the poor tactile feedback of these wires, careful attention
should be paid to avoid the creation of long subintimal dissections.
* The majority of operators will choose a hydrophobic spring coil dedicated
guide wire for a CTO to start the procedure, with a step-up approach with wires
of moderate stiffness at the beginning with a subsequent switch to wires of
greater tip load for penetration capacity. Others believe that the risk of
dissections can be reduced and the procedure shortened by selecting stiffer
wires in the first place.
* Operators should be familiar and use a limited set of or dedicated CTO guide
wires.
* The wires should be used in combination with a microcatheter *NovaCross*
micro catheter to assist in preventing flexion and prolapsing of the wire
transmitting the push directly to the tip, facilitating torque transmission and
allowing wire exchange, which is frequently needed during a CTO procedure.
During the Procedure:
Unless previously failed CTO crossing attempt was documented, the operator
should attempt to cross the CTO with guidewire for 10 minutes. Then after, The
CTO will be penetrated and crossed using a designated CTO guide wire (A number
of dedicated guide wires are available for CTO crossing. Individual operators
will select a guidewire with crossing characteristics that are likely to be
successful for the specific anatomy encountered in the procedure. However, the
wires should be used in combination with a NovaCross* micro catheter to assist
in preventing flexion and prolapsing of the wire transmitting the push directly
to the tip, facilitating torque transmission and allowing wire exchange, which
is frequently needed during a CTO procedure.) assisted by the NovaCross* micro
catheter. The NovaCross* will be placed/ positioned just proximal to the CTO
site (~5-15 mm) to facilitate the guide wire crossing procedural step. The
Nitinol loops will be deployed prior and during guide wire penetration and
propagation throughout the blocked segment. Following CTO guidewire crossing,
angiographic imaging will be obtained, the Nitinol loops will be collapsed and
the NovaCross* withdrawn. An Investigator chosen revascularization method
should follow.
Review of existing angiographic data of the treated vessel's post CTO crossing
should be obtained. Blood workup post procedure will occur at 3-6 hours and
then 12±4 hours to measure Troponin and CK-MB along with an ECG to assess for
peri-procedural myonecrosis.
The need for epinephrine given during the procedure and signs or symptoms of
anaphylaxis will be captured and information relating to the causality will be
provided.
Study burden and risks
Risks of PTCA are uncommon, and the procedure is widely practiced. Typical
known risks or discomforts anticipated as a result of a PTCA procedure include:
* Recurrence of angina
* Chest discomfort
* Bleeding from catheter the insertion point
* Bruising at the catheter insertion point
* Hematoma at catheter insertion point
* Ischemia due to restenosis of the dilated segment
* Ventricular failure
* Dissection or thrombosis with vessel occlusion
* Arterial Perforation
* Surgery required
* Vessel trauma
* Blood Toxicity
* Infection
* Toxicological response
* Fever
i. Rare risks as a result of a PTCA procedure
* Infection at skin puncture site
* Allergic reaction to contrast dye
* Deterioration of kidney function/kidney failure
* Provocation of heart attack/stroke
* Surgery to recover failed devices
* Surgery to repair a failed procedure
* Prolonged procedure time
* Occlusion of a branch of coronary artery
* Myocardial infarction with release of CK-MK into circulation
* Death
* When failures of PTCA occur, they are often treated using coronary artery
bypass surgery
8 Hamada St. 12892
Herzliya 4673342
IL
8 Hamada St. 12892
Herzliya 4673342
IL
Listed location countries
Age
Inclusion criteria
1. Adult aged 25-80
2. Patient understands and has signed the study informed consent form.
3. Patient has an angiographic documented Chronic Total Occlusion (i.e. >3 months occlusion duration) showing distal TIMI flow 0.
4. Suitable candidate for non-emergent, coronary angioplasty
5. Documented coronary angiography preceding the PCI reveals at least one CTO lesion situated in a non-infarct related coronary artery or its side branches with the following characteristics:
a) Thrombolysis in Myocardial Infarction (TIMI) 0 flow for at least 90 days;
b) Satisfactory distal vessel visualization
c) CTO should be amenable to percutaneous treatment and must be located in a coronary vessel with a reference diameter of at least 2 millimeters.
d) CTO refractory to a minimum of 10 minutes of conventional guide wire attempt.
6. Body Mass Index (BMI) < 40
7. Left ventricle ejection fraction > 25%
For the purpose of this trial, a CTO is defined as a 100% luminal narrowing without antegrade flow or
Exclusion criteria
1. Patient unable to give informed consent.
2. Current participation in another study with any investigational drug or device.
3. Patient is known or suspected not to tolerate the contrast agent.
4. Aorto-ostial CTO location (Ostial bifurcation origins may be considered), SVG CTO, in-stent CTO.
5. Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor).
6. Appearance of a fresh thrombus or intraluminal filling defects.
7. Recent major cerebrovascular event (history of stroke or TIA within 1 month)
8. Cardiac intervention within 4 weeks of the procedure
9. Renal insufficiency (serum creatinine of > 2.3mg/dl or 203umol/L)
10. Active gastrointestinal bleeding
11. Active infection or fever that may be due to infection
12. Life expectancy < 2 years due to other illnesses
13. Significant anemia (hemoglobin < 8.0 mg / dl)
14. Severe uncontrolled systemic hypertension (> 240 mmHg within 1 month of procedure)
15. Severe electrolyte imbalance
16. Congestive heart failure [New York Heart Association (NYHA) Class III\IV] CSA Class IV.
17. Unstable angina requiring emergent percutaneous trans-luminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG)
18. Recent myocardial infarction (MI) (within the past two weeks)
19. Uncontrolled diabetes >2 serum glucose concentrations of >350 mg/dl within 7 days.
20. Unwillingness or inability to comply with any protocol requirements
21. Pregnant or nursing
22. Extensive prior dissection from a coronary guidewire use
23. Drug abuse or alcoholism.
24. Patients under custodial care.
25. Bleeding diathesis or coagulation disorder;
26. Kawasaki's disease or other vasculitis.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL51902.029.14 |