MedTrace Logo

Trial to Demonstrate the Safety and Effectiveness of the MiStent II for the Revascularization of Coronary Arteries.

NCT03423511 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1300

Last updated 2020-09-04

No results posted yet for this study

Summary

To compare MiStent to either the Xience or Promus stents.with the primary objective being to assess the safety and efficacy of the MiStent in a patient population requiring revascularization of de novo obstructive lesions of coronary arteries in patients with stable and unstable coronary artery disease (CAD) including non ST-Elevation Myocardial Infarction (NSTEMI)

Conditions

Interventions

DEVICE

MiStent II coronary artery stent

Implantation of a coronary stent patient with stable and unstable coronary artery disease including non-ST-Elevated Myocardial Infarction

DEVICE

Xience or Promus coronary artery stents

Implantation of a coronary stent patient with stable and unstable coronary artery disease including non-ST-Elevated Myocardial Infarction

Sponsors & Collaborators

  • Baim Institute for Clinical Research

    collaborator OTHER

  • North American Science Associates Inc.

    collaborator UNKNOWN

  • Yale Cardiovascular Research Group

    collaborator OTHER

  • Micell Technologies

    lead INDUSTRY

Principal Investigators

  • Laura Mauri, MD, MSc · Brigham and Women's Hospial

  • Dean Kereiakes, MD · The Christ Hospital

  • David Kandzari, MD · Piedmont Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2023-06-01
Completion
2027-06-01
FDA Device
Yes

More Related Trials

Entities

Diseases

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 NCT03423511 on ClinicalTrials.gov