Artimes Pro Low Profile Dilatation Catheters for Pre-Dilatation in Patients With Symptomatic Ischemic Heart Disease

NCT03301246 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-06-11

No results posted yet for this study

Summary

This is a prospective, non-randomized, open label, multi-center study including 60 patients with symptomatic ischemic heart disease with 70%-100% coronary artery stenoses and occlusions enrolled and treated in this investigational device study.

Conditions

Interventions

DEVICE

Artimes Pro Low Profile Dilatation Catheter

Pre-dilation catheter for the purpose of preparing the vessel to deliver the final therapy.

Sponsors & Collaborators

  • BrosMed Medical Co., Ltd

    collaborator INDUSTRY
  • Eminence Clinical Research, Inc.

    lead INDUSTRY

Principal Investigators

  • Jasvinder Singh, MD · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-31
Primary Completion
2020-01-29
Completion
2020-05-08
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT03301246 on ClinicalTrials.gov