Trials / Completed
CompletedNCT01294748
Clinical Investigation of the MiStent Drug Eluting Stent (DES) in Coronary Artery Disease
Clinical Investigation of a DES (MiStent™ System) With Sirolimus and a Bioabsorbable Polymer for the Treatment of Patients With De Novo Lesions in Native Coronary Arteries.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 184 (actual)
- Sponsor
- Micell Technologies · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The DESSOLVE II clinical trial is to assess the safety and performance of the sirolimus-eluting MiStent as compared to the Endeavor DES 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
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2011-02-01
- Primary completion
- 2012-06-01
- Completion
- 2016-08-01
- First posted
- 2011-02-11
- Last updated
- 2017-02-08
- Results posted
- 2014-03-26
Locations
28 sites across 6 countries: Belgium, France, Netherlands, New Zealand, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT01294748. Inclusion in this directory is not an endorsement.