MGuard™ Prime Embolic Protection Stent in Patients With Acute ST Elevation Myocardial Infarction

NCT02292823 | Terminated DMC

• 1 other identifier: IMD-13
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, non-randomized, single arm, multicenter observational study. The objective is to evaluate the safety and efficacy of the MGuard™ Prime stent in the treatment of de novo stenotic lesions in coronary arteries in patients undergoing primary percutaneous coronary intervention (PCI) due to acute ST elevation myocardial infarction (STEMI) in a real-world setting.

Conditions

ST Elevation Myocardial Infarction

Keywords

STEMI; heart attack; stent; Bare Metal Stent; myocardial infarction; PCI

Outcome Measures

Primary Outcomes (2)

• Complete ST-segment resolution

  1 day

• All cause death or MI at 30 days

  30 days

Secondary Outcomes (4)

• TIMI flow grade

  1 day

• Major Adverse Cardiac Events rate (MACE): cardiac death, re-MI, clinically-driven target lesion revascularization (TLR)

  Discharge, 30 days, 6 months, 12 months

• Acute success rates

  1 day

• Stent thrombosis rate

  Discharge, 30 days, 6 months,12 months

Interventions

MGuard™ Prime Embolic Protection Stent System DEVICE

Also known as: MGuard™ Prime EPS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects undergoing primary revascularization for STEMI and who are intended to undergo primary PCI with the MGuard™ Prime Embolic Protection Stent System.

You may qualify if:

• Subject is \>18 years of age.
• Subject is experiencing clinical symptoms consistent with ST elevation acute myocardial infarction (STEMI) of \>30 minutes and \<24 hours.
• Based on coronary anatomy, primary PCI is indicated for the culprit lesion with anticipated use of stenting.
• Subject agrees to all required follow-up procedures and visits and has provided informed consent where required.
• The target lesion is a de novo lesion in a native coronary artery.
• The reference vessel diameter (RVD) of the infarct lesion is 2.75-4.0 mm by visual assessment.

You may not qualify if:

• Subject undergoing cardiopulmonary resuscitation.
• Cardiogenic shock (SBP \<80 mmHg for \>30 minutes, or requiring IV pressors or intra-aortic balloon bump (IABP) or other hemodynamic support device for hypotension).
• Co-morbid condition(s) or others that could limit the subject's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.
• Target lesion involves a bifurcation with a side branch \>/=2.0 mm in diameter.
• In the Investigator's opinion the lesion/vessel is unsuitable for treatment with the MGuard™ Prime Embolic Protection Stent System for any reason.

Sponsors & Collaborators

• InspireMD: lead

Study Sites (1)

Onze Lieve Vrouwe Gasthuis

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2014
• First Posted: November 17, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2016
• Last Updated: September 2, 2015

Record last verified: 2015-08

Locations

NL (1)