The primary objective of this first-in-man safety and feasibility study is to assess the safety of the Volcano PreView FL.IVUS catheter when used after successful coronary stenting.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety
To evaluate the acute, and immediately post-imaging safety of the Volcano
PreView FL.IVUS catheter in vivo. This will be assessed by inserting the
catheter into the coronary artery after successful and uncomplicated coronary
stenting, imaging the stent and the artery just distal and proximal to the
stent, followed by the withdrawal of the catheter.
Efficacy
Clinical success will be assessed by evaluating the ability of the Volcano
PreView FL.IVUS catheter to visualize the vessel wall (in particular, the
medial layers), lumen and stent struts in coronary arteries.
Secondary outcome
The second primary objective of this study is to demonstrate the technical
feasibility of imaging and evaluate the efficacy of the Preview FL.IVUS
catheter and system.
Background summary
It is often stated that successful recanalization of chronic total occlusions
(CTOs) of native coronary arteries represents the "last frontier" of
Percutaneous Coronary Intervention (PCI). This statement is made in deference
to the fact that CTOs represent the most technically challenging lesion subset
that interventional cardiologists face, with procedural success rates
considerably lower than those achieved in non-occluded coronary vessels or
acutely occluded arteries. CTOs are associated with significant angina,
impaired left ventricular function, and worse long-term outcomes. Percutaneous
coronary interventions in CTOs are unsuccessful in up to 50%-70% of cases,
primarily because of inability to cross the lesion with a guide wire (Stone et
al. Circ 2004). [1]
Coronary dilatation catheters and Intravascular Ultrasound Imaging (IVUS) are
often used as complementary technologies to provide diagnostic accuracy for
coronary interventions. IVUS catheters are indicated for the evaluation of
vascular morphology in blood vessels of the coronary and peripheral vasculature
by providing a cross-sectional image of such vessels. They are designed for use
as an adjunct to conventional angiographic procedures to provide an image of
the vessel lumen and wall structures.
Study objective
The primary objective of this first-in-man safety and feasibility study is to
assess the safety of the Volcano PreView FL.IVUS catheter when used after
successful coronary stenting.
Study design
A first in men, non-randomized, unblinded, single center, prospective forward
looking PreView FL.IVUS catheter study in patients scheduled for coronary
stenting.
Intervention
The key feature of the Volcano FL.IVUS catheter to be used in this feasibility
trial is its ability to obtain a forward-looking view of the vascular anatomy
in front of the distal tip of the catheter. In the case of chronic total
occlusion of the artery to be opened, this is important so that one has the
opportunity to evaluate the vessel anatomy (especially the vessel wall) in a
forward-looking fashion without the need to advance the distal tip of the
catheter into the healthy wall of the artery and perhaps damage tissues or
extend dissections unnecessarily. Forward-looking IVUS imaging may also allow
the physician to safely advance the guide wire inside the vessel, avoiding
possible vessel wall injury.
Study burden and risks
The potential risks and benefits of participation in this study are clearly
identified in the subject consent form and will be explained to the patient
and/or his/her legal representative prior to participating in the study. There
are potential risks to the subject associated with participation in this study
of the Volcano PreView FL.IVUS catheter. Potential risks to the subject include
the risks standard to coronary angiography. These risks include but are not
limited to:
• thrombosis, embolization, dissection, perforation or rupture of the coronary
artery, myocardial infarction, other ischemic events, death, allergic reaction
to the contrast agent, renal failure, bleeding, infection, low blood pressure,
abnormal heart rhythm, cardiac tamponade, unstable angina, stroke, neurological
complications, plaque rupture
All the above can lead to prolonged illness, permanent damage, or in rare
cases, death.
2870 Kilgore Road
Rancho Cordova, CA 95670
US
2870 Kilgore Road
Rancho Cordova, CA 95670
US
Listed location countries
Age
Inclusion criteria
Stable patients scheduled to undergo single vessel coronary stenting due to symptoms of stable angina.
Patient must be between the ages of 21 and 85 years old.
Patient must be able to read, understand and sign the informed consent document before the planned procedure.
Exclusion criteria
-. Planned surgical percutaneous coronary intervention within 30 days.
-. Severe vascular disease, tortuosity, or angiographic evidence of thrombus.
-. A recent MI
-. Braunwald classification of unstable angina AI, II and III. (see Appendix 3)
-. Mainstem leasion
-. Ostial lesions.
-. Bifurcation lesions double guide wires.
-. Total occlusions.
-. Left ventricular ejection fraction (LVEF) of less than 30%
-. Clinically significant valvular disease.
-. CVA.
-. Persistent, uncontrolled hypertension
-. Hemodynamic instability
-. Significant (as determined by the investigator) gastro-intestinal bleeding in the past 3 months.
-. Contra-indication to antithrombotic regimen of anticoagulation therapy.
-. Patient is known that susceptible to vascular spasm.
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 | NL27775.078.10 |