Acute Coronary Syndrome
Conditions
Brief summary
Indication for use: The Svelte DES is indicated for improving coronary luminal diameter in patients with symptomatic heart disease, including patients with non-ST elevation MI due to discrete de novo native coronary artery lesions. The treated lesion length should be less than the nominal stent length with a reference vessel diameter of 2.25 mm - 4.00 mm
Interventions
DEVICEDES
PCI with implantation of a DES
Sponsors
Svelte Medical Systems, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is an eligible candidate for percutaneous coronary intervention (PCI); * Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia; * Subject is an acceptable candidate for coronary artery bypass grafting (CABG); * Subject has up to 3 de novo target lesions in up to 2 native coronary artery vessels, with no more than 2 lesions in a single vessel, each meeting the angiographic criteria and none of the
Exclusion criteria
. * Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥ 2.25 mm and ≤ 4.00 mm;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Lesion Failure (TLF) | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Target Vessel Failure (TVF) | 6 and 12 months, and annually through 5 years |
| Major Adverse Cardiac Event (MACE) | 6 and 12 months and annually through 5 years follow-up |
| Stent Thrombosis | 6 and 12 months and annually through 5 years follow-up |
Countries
Japan, Netherlands, United States
Outcome results
None listed