Trials / Terminated
TerminatedNCT01869738
MGuard™ Prime Stent System Clinical Trial in Patients With Acute ST Elevation Myocardial Infarction
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 310 (actual)
- Sponsor
- InspireMD · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety and efficacy of the MGuard™ Prime stent in the treatment of blocked arteries in coronary arteries in patients undergoing a stenting procedure due to having a heart attack. The MGuard Prime stent wil be compared to other FDA approved bare-metal (BMS) or drug-eluting (DES) coronary stents. The hypotheses are that (1) the MGuard Prime stent will achieve a higher rate of complete ST-segment resolution as seen on the post-procedure ECG as compared to the comparator stent, and will have a similar effect on the rate of all-cause death or recurrent target vessel myocardial infarction at 365 days post-procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MGuard Prime | |
| DEVICE | (BMS/DES) |
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2015-08-01
- Completion
- 2015-08-01
- First posted
- 2013-06-05
- Last updated
- 2015-09-02
Locations
56 sites across 12 countries: United States, Belgium, Czechia, Estonia, Finland, France, Germany, Israel, Netherlands, Poland, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01869738. Inclusion in this directory is not an endorsement.