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Feasibility Study of the Amaranth Medical FORTITUDE Bioresorbable Drug-Eluting Coronary Stent

NCT02189499 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2016-06-08

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and feasibility of a new coronary artery stent for treating blockages in the arteries supplying blood to the heart muscle. The Amaranth FORTITUDE scaffold releases a drug (sirolimus) to reduce the likelihood of the treated blood vessel developing a new blockage. In addition, the scaffold dissolves away over time, leaving no permanent implant after the blood vessel has healed. This study will will be the first evaluation of this stent in humans.

Conditions

Interventions

DEVICE

AmM FORTITUDE Bioresorbable Drug-Eluting Coronary Scaffold

Placement of the investigational device into the diseased coronary artery to eliminate the vascular stenosis.

Sponsors & Collaborators

  • Amaranth Medical Inc.

    lead INDUSTRY

Principal Investigators

  • Juan F Granada, MD · Skirball Center for Cardiovascular Research, Columbia University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-06-30
Completion
2020-11-30

Countries

  • Colombia

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 NCT02189499 on ClinicalTrials.gov