NCT02067091

Performance of Bioresorbable Scaffold in Primary Percutaneous Intervention of ST Elevation Myocardial Infarct

Performance of Bioresorbable Scaffold in Primary Percutaneous Intervention of ST Elevation Myocardial Infarct (BVS in STEMI)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients presenting with acute ST elevation myocardial infarct urgently need revascularization. Standard of care is establishing bloodflow through the coronary vessels using thrombus aspiration catheter, and securing the result by using a metallic drug eluting stent. New kinds of non-metallic bioresorbable stents are now available. They have however challenges in structural strength. The investigators want to compare the new bioresorbable scaffold with traditional metallic stents in this setting in a prospective, randomized, non-blinded, multicenter study in 120 patients. The investigators will use an imaging technique, optical coherence tomography, to evaluate the results after 12 months. The investigators also want to see if modern multislice computed tomography can give useful information in the follow-up of stented coronary arteries after 12 and 24 months.

Detailed description

Patients presenting with ST elevation myocardial infarction for primary PCI (percutaneous coronary intervention) will be screened. After thrombus aspiration, patient will be asked for oral consent if TIMI flow 2-3. Patient will then be randomized between drug eluting stent (Xience pro, Abbott Vascular Solutions) and bioresorbable scaffold (Absorb, Abbott Vascular Solutions). Optical coherence tomography (OCT) will be performed before stenting and after final result. Stent will be deployed without further predilatation if possible. Follow up at 12 months (clinical, angio with OCT and multislice CT coronary angiogram (MSCT-CA)) and 24 months (MSCT-CA).

Conditions

• Acute ST Segment Elevation Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	stent implant in a coronary artery	Implantation of device called a stent in a coronary artery Percutaneous coronary intervention

Timeline

• Start date: 2014-08-01
• Primary completion: 2018-04-01
• Completion: 2020-08-01
• First posted: 2014-02-20
• Last updated: 2017-05-31

Locations

2 sites across 2 countries: Denmark, Norway