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OPTIMIZE IDE for the Treatment of ACS

NCT03190473 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1630

Last updated 2023-03-23

No results posted yet for this study

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

Conditions

  • Acute Coronary Syndrome

Interventions

DEVICE

DES

PCI with implantation of a DES

Sponsors & Collaborators

  • Svelte Medical Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Shing C Wong, MD · Svelte Medical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-02
Primary Completion
2020-07-17
Completion
2023-03-08
FDA Device
Yes

Countries

  • United States
  • Japan
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03190473 on ClinicalTrials.gov