NCT01247428

First-In-Human Trial of the MiStent Drug-Eluting Stent (DES) in Coronary Artery Disease

A First-In-Human Trial of a New Novel DES (MiStent System) With Sirolimus and a Bioabsorbable Polymer for the Treatment of Patients With De Novo Lesions in the Native Coronary Arteries

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Micell Technologies · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The DESSOLVE I clinical trial is to assess the safety and performance of the sirolimus-eluting MiStent SES.

Detailed description

The DESSOLVE I 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 \< 20 mm in length in the native coronary arteries with reference vessel diameters between 2.5 mm and 3.5 mm.

Conditions

• Coronary Artery Disease

Interventions

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

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-09-01
• Completion: 2016-03-01
• First posted: 2010-11-24
• Last updated: 2016-12-19
• Results posted: 2014-06-12

Locations

5 sites across 3 countries: Australia, Belgium, New Zealand