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Clinical Investigation of the MiStent Drug Eluting Stent (DES) in Coronary Artery Disease

NCT01294748 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2017-02-08

Study results available
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Summary

The DESSOLVE II clinical trial is to assess the safety and performance of the sirolimus-eluting MiStent for the treatment for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions in the native coronary arteries.

Conditions

Interventions

DEVICE

MiStent DES

The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).

DEVICE

Endeavor DES

The Endeavor is a device/drug combination comprised of two components; a stent and a drug product (everolimus within a durable polymer coating).

Sponsors & Collaborators

  • Micell Technologies

    lead INDUSTRY

Principal Investigators

  • William Wijns, MD · Cardiovascular Center, Onze-Lieve-Vrouwziekenhuis Aalst (OLV Hospital)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-06-30
Completion
2016-08-31

Countries

  • Belgium
  • France
  • Netherlands
  • New Zealand
  • Sweden
  • United Kingdom

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 NCT01294748 on ClinicalTrials.gov