MedTrace Logo

Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE)

NCT01930214 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2023-07-18

Study results available
· View outcomes & findings →

Summary

The objective of this study is to assess the current standard of care treatment outcome in none/mild, moderate and severely calcified coronary lesions using:

* A composite of MACE at 30-day and one (1) year post procedure, and
* Procedural and lesion success

Conditions

Interventions

DEVICE

Percutaneous Coronary Intervention

Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Samin K Sharma, MD · Icahn School of Medicine at Mount Sinai

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-26
Primary Completion
2016-11-07
Completion
2017-06-01

Countries

  • United States

Study Locations

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 NCT01930214 on ClinicalTrials.gov