NCT01986803

ABSORB STEMI: the TROFI II Study

Comparison of the ABSORBTM Everolimus Eluting Bioresorbable Vascular Scaffold System With a Drug- Eluting Metal Stent (XienceTM) in Acute ST-Elevation Myocardial Infarction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 191 (actual)
• Sponsor: ECRI bv · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Prospective, randomized (1:1), active control, single-blind, non-inferiority, European multicenter clinical trial. The primary objective of this study is to assess the neointimal healing score (as evaluated by intra-coronary OFDI) in patients with ST-elevation Myocardial Infarction (STEMI) and treated with Abbott Vascular ABSORB everolimus eluting bioresorbable vascular scaffold (BVS) at 6 months follow-up by comparing with a metallic drug eluting stent (XIENCE). Furthermore, the safety and feasibility of implanting ABSORB BVS in patients with STEMI is assessed. It is hypothesized that acutely and at 6 months follow-up implantation of the ABSORB fully bioresorbable everolimus-eluting scaffold is at least as safe as implantation of metallic drug-eluting stent, and that at late follow-up the ABSORB scaffold could improve the arterial healing process and potentially reduce late stent thrombosis in patients presenting with STEMI. This is a preparatory trial in anticipation of a major outcome study.

Detailed description

A total of 190 patients will be included in this trial, at 8-10 European sites. The primary endpoint is arterial healing at 6 month follow up. To assess the arterial healing, at 6 months follow-up all patients will undergo angiographic follow-up with OFDI investigation. To score the arterial healing, a Healing Score is used.

Conditions

• Acute ST Segment Elevation Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	Percutaneous Coronary Intervention	Implanting a device ("Xience Xpedition" stent or "Abbott Vascular ABSORBTM everolimus eluting bioresorbable vascular scaffold system (BVS)" to open a diseased coronary artery by going to the coronary artery subcutaneously through the arteries from the radial or femoral artery access point.

Timeline

• Start date: 2014-01-06
• Primary completion: 2015-04-13
• Completion: 2017-09-21
• First posted: 2013-11-19
• Last updated: 2018-07-24

Locations

8 sites across 4 countries: Denmark, Netherlands, Spain, Switzerland