To evaluate the 30-day Safety and Performance of the SOAW Coronary Stent System in the treatment of de novo coronary lesions.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Major Adverse Cardiac Events (MACE): defined as cardiac death, MI [Q or Non
Q-wave], emergent bypass surgery, or clinically driven target lesion
revascularization (TLR) by percutaneous or surgical methods at 30 days.
Secondary outcome
1. Target vessel failure (TVF), defined as cardiac death, target vessel
myocardial infarction (MI) [Q or Non Q-wave], or clinically driven target
vessel revascularization (TVR) by percutaneous or surgical methods at 6 months
2. Angiographic Restenosis rate at 6 months (for 50 patients)
3. Composite endpoint of cardiac death and MI at 30 days and 6 months post
procedure
4. TLR at 30 and 180 days
5. Rates for each component of the MACE composite endpoint (cardiac death, MI,
emergent coronary artery bypass graft (CABG)), and TLR at 30 days and 6 months
post-procedure
6. Rates for each component of target vessel failure (TVF) composite endpoint
(cardiac death, target vessel MI, TVR) reported at 30 days and 6 months
post-procedure
7. Acute success rates:
a. Device Success: Attainment of < 30% final residual stenosis of the target
lesion using only the Svelte Stent.
b. Lesion Success: Attainment of < 30% final residual stenosis of the target
lesion using any percutaneous method.
c. Procedure Success: Attainment of < 30% final residual stenosis of the target
lesion and no in-hospital MACE.
d. Direct Stenting Success: Attainment of < 30% final residual stenosis of the
target lesion using the Svelte Stent without predilation.
8. Bleeding or vascular complications at discharge
9. Late stent thrombosis at 6 months
10. Procedural resource utilization
11. SOAW performance evaluation at implant
Background summary
Conventional practice in PCI with stenting is to perform predilatation of the
target lesion prior to stent placement. This convention was dictated by the
first generation stent characteristics. The initial stent designs were large
profile, stiff devices making deliverability an issue. Additionally, these
stents were hand-crimped onto the balloon catheter, resulting in tenuous
securement of the device onto the delivery system. 5, 6 These features made
predilatation of the target lesion mandatory to permit stent placement. Current
stent delivery systems allow for stent placement without predilatation, a
strategy known as direct stenting.
The Svelte Medical Systems Stent-On-A-Wire (SOAW) system is a coronary stent
delivery system using a fixed-wire catheter platform. The system consists of a
wire, balloon, and cobalt chromium stent. The Svelte SOAW system represents the
next generation iteration of fixed wire technology and is unique in that it has
a direct stenting indication by design. The introduction of SOAW technology to
the practice of PCI would represent a significant advance in the field.
Study objective
To evaluate the 30-day Safety and Performance of the SOAW Coronary Stent System
in the treatment of de novo coronary lesions.
Study design
This is a prospective, nonrandomized, single-arm study to be conducted at a
single European site.
Intervention
Studystent implantation, followed by OCT during initial procedure and 6 month
follow-up angio with OCT.
Study burden and risks
It is to be expected that the risks are identitical to those of a conservative
PCI with stenting, with the acception that an extra catheter is introduced
(OCT). It should also be noted that a 6 month angio with OCT will be performed.
127 Main Street
Chatham, NJ 07928
USA
127 Main Street
Chatham, NJ 07928
USA
Listed location countries
Age
Inclusion criteria
- Patient >18 years old.
- Eligible for percutaneous coronary intervention (PCI).
- Patient understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.
- Patient is willing to comply with specified follow-up evaluation.
- Acceptable candidate for coronary artery bypass graft (CABG) surgery.
- (un)stable angina pectoris or a positive functional ischemia study.
- Male or non-pregnant female patient of non child-bearing potential.
- A number of specific Angiographic Inclusion Criteria (see protocol).
Exclusion criteria
- Currently enrolled in another trial that has not completed the primary endpoint.
- A previous coronary interventional procedure < 30 days prior to the procedure.
- The patient requires a staged procedure within 30 days post-procedure.
- The target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).
- Previous bare metal stent (BMS) deployment anywhere in the target vessel within the past 6 months.
- Any DES deployment anywhere in the target vessel within the past 9 months.
- Co-morbid condition(s) that could limit the patient*s ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.
- Concurrent medical condition with a life expectancy of <12 months.
- Documented LVEF < 30% at the most recent evaluation.
- Evidence of an AMI within 72 hours of the intended trial procedure.
- History of cerebrovascular accident or TIA <6 months.
- Specific Angiographic Exclusion Criteria, incl left main lesion (see protocol)
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 | NL28452.078.09 |