Svelte SOAW Coronary Stent Clinical Observational Study

Completed

• Conditions: angina; coronary artery disease; 10011082

• Registration Number: NL-OMON33323
• Lead Sponsor: Svelte Medical Systems, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Major Adverse Cardiac Events (MACE): defined as cardiac death, MI [Q or Non<br /><br>Q-wave], emergent bypass surgery, or clinically driven target lesion<br /><br>revascularization (TLR) by percutaneous or surgical methods at 30 days.</p><br>