NCT02151929

Bioresorbable Vascular Scaffold in Patients With Myocardial Infarction

Bioresorbable Vascular Scaffold in Patient With ST Elevation Myocardial Infarction: a Randomized Comparison With Everolimus Eluting Stent

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: San Giuseppe Moscati Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of the feasibility and safety of Bioresorbable Vascular Scaffold (BVS) in patient treated with primary PCI (pPCI).

Detailed description

Background. Drug-eluting stent (DES) implantation may offer benefits in terms of repeat revascularization in patients with ST elevation myocardial infarction (STEMI). The everolimus eluting bioresorbable vascular scaffold (BVS) has shown efficacy and safety in stable patient but not in acute coronary syndromes. The study tested the feasibility and safety of BVS in patient treated with primary PCI (pPCI) Methods. Consecutive STEMI patients admitted within 12 hours of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-hour primary PCI capability will be randomly assigned to everolimus eluting stent (EES) or BVS. Primary endpoints are procedural and clinical success. The MACE (cardiac death, non fatal myocardial infarction, target lesion revascularization (TLR)) and definite or probable ST will be evaluated at six months.

Conditions

• ST Elevation Acute Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	Bioresorbable vascular scaffold	stenting of an acute thrombotic lesion in patient within STEMI
DEVICE	Everolimus eluting stent	stenting of an acute thrombotic lesion in patient within STEMI

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-08-01
• Completion: 2014-04-01
• First posted: 2014-06-02
• Last updated: 2014-06-02

Locations

1 site across 1 country: Italy